Document:

Exhibit 10.14

 

EXECUTION COPY

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[...***...].” A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

 

PURCHASE OF RIGHTS AGREEMENT

 

This Purchase of Rights Agreement (this “Agreement”), effective as of October 1, 2015 (the “Effective Date”), is by and between BeiGene, LTD, a corporation organized under the laws of the Cayman Islands having an address of c/o Mourant Ozannes Corporate Services, (Cayman) Limited, 94 Solaris Avenue, PO Box 1348, Grand Cayman KY1-1108, Cayman Islands GB (“BeiGene”), and Merck KGaA, a corporation with general partners organized under German law having a place of business at Frankfurter Strasse 250, 64293 Darmstadt, Germany (“Merck”).  BeiGene and Merck may be referred to herein as a “Party” or collectively as the “Parties.”

 

WHEREAS, the Parties are parties to the License Agreement, with an Effective Date of October 25, 2013 pertaining to the “Merck Territory”, as defined below (the “Ex-PRC Agreement”) and the License Agreement, with an Effective Date of October 25, 2013 pertaining to the “BeiGene Territory”, as defined below (the “PRC Agreement”);

 

WHEREAS, the Parties intend the PRC Agreement to continue in effect, as modified by this Agreement; and

 

WHEREAS, the Parties wish to provide for the purchase by BeiGene of all of Merck’s rights under the Ex-PRC Agreement as set forth herein and provide for the survival of certain provisions of the Ex-PRC Agreement as needed to effect the continuation of the PRC Agreement;

 

NOW, THEREFORE, in consideration of the various promises and undertakings set forth herein, the Parties agree as follows:

 

1.                                      Definitions.  The following terms shall have the following meanings:

 

1.1.                            “Merck Territory” means all the countries of the world, except the PRC Territory.

 

1.2.                            “BeiGene Territory” means The People’s Republic of China, excluding Hong Kong, Macau and Taiwan.

 

1.3.                            Capitalized terms used in herein but not defined shall have the meanings set forth in the PRC Agreement, or, if not defined in the PRC Agreement, as defined in the Ex-PRC Agreement.

 

2.                                      Purchase of Rights under the Ex-PRC Agreement.

 

2.1.                            Merck hereby sells and transfers all of its rights under the Ex-PRC Agreement to BeiGene, and agrees that Merck shall have no further rights and obligations under the Ex-PRC Agreement. The Ex-PRC Agreement is hereby terminated, except as set forth below.

 

3.                                      The PRC Agreement.

 

3.1.                            The PRC Agreement shall continue in full force and effect, except as set forth below.

 

 

4.                                      Payments.

 

4.1.                            Within [...***...] from the Effective Date in consideration of the termination of the Ex-PRC Agreement, BeiGene shall pay Merck a one-time payment net of any deductions and taxes on the payment (e.g. withholding tax, sales tax, vat or similar transactional taxes) of Ten Million US dollars (US$ 10,000,000). The Ex-PRC Agreement shall terminate upon payment of the aforementioned amount.

 

4.2.                            No other or further payments shall be due from BeiGene to Merck with regard to the transfer of Ex-PRC rights to BeiGene under this Agreement.

 

5.                                      Survival of Certain Provisions of the Ex-PRC Agreement.

 

5.1.                            All provisions of the Ex-PRC Agreement that are required in the event Merck exercises its rights under Section 2.3 or 2.4 of the PRC Agreement shall survive, solely for purposes of effecting the results of such exercise.  In addition, only the following provisions of the Ex-PRC Agreement shall survive the termination of the Ex-PRC Agreement:  Articles 1 (Definitions), 8 (Confidentiality) (other than Section 8.4 (Publications) and Section 8.5 (Press Releases and Disclosure), and with respect to the remaining sections only for the time period set forth in Section 8.1), 12 (Dispute Resolution), and 13 (Miscellaneous)(other than 13.2 (Assignment) and 13.4 (Change of Control)); and Sections 2.3(b) (No Other Rights); 10.4 (No Consequential Damages), and, without regard to the basis of termination,   Section 11.5(b)(ii).

 

6.                                      Amendment of Certain Provisions of the PRC Agreement.

 

The following provisions of the PRC Agreement are amended as set forth below:

 

6.1.                            Sections 2.1(a) and 2.1(b) are amended by replacing the words “and the Other License Agreement” with the words “and the surviving provisions of the Other License Agreement.”

 

6.2.                            Section 2.4, as previously amended, is amended by replacing the words “12-5 Status” with the words “12-5 Status or 13-5 Status.”

 

6.3.                            Section 3.5 is amended by (i) deleting the payment specified for the first milestone set forth therein [...***...],  and (ii) reducing the payments specified for the other milestones set forth therein by [...***...].

 

6.4.                            Section 7.3(c) is deleted.

 

6.5.                            Section 9.9 is amended by replacing the words “and the Other License Agreement” with the words “and the surviving provisions of the Other License Agreement.”

 

7.                                      Option Agreement for Combination Clinical Trials.  On the same day as of the Effective Date of this Agreement, the Parties shall enter into an option agreement (the “Option Agreement”) that provides Merck with the option to ask for Combination Clinical Trials (as defined in the Option Agreement).

 

8.                                      Press Release.  The Parties agree that there will be no press release covering the execution of this Agreement and the Option Agreement.

 

9.                                      Miscellaneous.  This Agreement supersedes all proposals, negotiations, conversations and/or discussions between or among parties relating to the subject matter of this Agreement.   No waiver, modification or amendment of any provision of this Agreement shall be valid or effective unless made in

 

*Confidential Information, indicated by [...***...], has been omitted from this filing and filed separately with the Securities and Exchange Commission.

 

 

a writing referencing this Agreement and signed by a duly authorized officer of each Party. Each Party agrees to execute, acknowledge and deliver such further instruments and to do all such other acts as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement. The captions to this Agreement are for convenience only, and are to be of no force or effect in construing or interpreting any of the provisions of this Agreement.  This Agreement shall be governed by and interpreted in accordance with the laws of England and Wales, excluding application of any conflict of laws principles that would require application of the Law of a jurisdiction outside of England and Wales, and will be subject to the exclusive jurisdiction of the courts of competent jurisdiction located in London, England.  Any notice, request, approval or consent required or permitted to be given under this Agreement shall be in writing and shall be deemed to have been sufficiently given if delivered in person, transmitted by facsimile (receipt verified) or by express courier service providing evidence of delivery to the Party to which it is directed at its address or facsimile number shown in Section 9.12 of the PRC Agreement or such other address or facsimile number as such Party shall have last given by notice to the other Party.  This Agreement may be executed in one or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same agreement.

 

 

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date.

 

 

	
BeiGene, LTD
    	
Merck   KGaA
    
	
 
    	
 
    	
 
    	
 
    
	
By:
    	
/s/   John V. Oyler
    	
 
    	
By:
    	
/s/   Birgit Reitmaier
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Name:
    	
John   V. Oyler
    	
 
    	
Name:
    	
Birgit   Reitmaier
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Title:
    	
Chief   Executive Officer
    	
 
    	
Title:
    	
Head   of Technologies and Biomarkers, Global Business Development &   Alliance Management
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
By:
    	
/s/   Jens Eckhardt
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
Name:
    	
Jens   Eckhardt
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
Title:
    	
Regional   General CounselExhibit 10.15

 

EXECUTION VERSION

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[...***...].” A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

 

OPTION AGREEMENT

 

This Option Agreement (this “Option Agreement”), effective as of October 1, 2015 (the “Effective Date”), is by and between BeiGene, LTD, a corporation organized under the laws of the Cayman Islands having an address of c/o Mourant Ozannes Corporate Services, (Cayman) Limited, 94 Solaris Avenue, PO Box 1348, Grand Cayman KY1-1108, Cayman Islands GB (“BeiGene”), and Merck KGaA, a corporation with general partners organized under German law having a place of business at Frankfurter Strasse 250, 64293 Darmstadt, Germany (“Merck”).  BeiGene and Merck may be referred to herein as a “Party” or collectively as the “Parties.”  The parties hereby agree as follows:

 

WHEREAS, the Parties are parties to the License Agreement, with an Effective Date of October 25, 2013 pertaining to the “Merck Territory”, as defined below (the “Ex-PRC Agreement”);

 

WHEREAS,  BeiGene has purchased all of the rights of Merck under the Ex- PRC Agreement and the Ex-PRC Agreement has terminated except as set forth in the Purchase of Rights Agreement between the Parties of even date herewith; and

 

WHEREAS, the Parties wish to provide for combination clinical trials of BeiGene PARP Inhibitors and Merck Proprietary Products on the terms set forth herein;

 

NOW, THEREFORE, in consideration of the various promises and undertakings set forth herein, the Parties agree as follows:

 

1.                                      Definitions.  The following terms shall have the following meanings:

 

1.1.                            “BeiGene PARP Inhibitor” means “Collaboration Compound” or another “Product” that is a “PARP Inhibitor” (each as defined in the Ex-PRC Agreement) owned or Controlled by BeiGene.

 

1.2.                            “Combination Clinical Trials” means clinical trials of a BeiGene PARP Inhibitor and a Merck Proprietary Product

 

1.3.                            “Major Country” means each of (i) the United States, (ii) any two (2) of the United Kingdom, Germany, France, Italy, Spain and (iii) Japan.

 

1.4.                            “Merck Proprietary Product” means a current or future product owned or Controlled by Merck.

 

1.5.                            “Merck Territory” means all the countries of the world, except the PRC Territory.

 

1.6.                            Capitalized terms used herein but not defined shall have the meanings set forth in the Ex-PRC Agreement.

 

2.                                      Future Agreements between the Parties.  At any time during the period from the Effective Date until the first Regulatory Approval received for the Commercialization of a BeiGene PARP Inhibitor (the

 

 

“Option Period”) in a Major Country, Merck may give written notice to BeiGene that Merck proposes to conduct a Combination Clinical Trial, which notice shall specify the Merck Proprietary Product to be included in such Combination Clinical Trial.  For clarity, during the Option Period, Merck may give multiple option notices relating to different Merck Proprietary Products as well as different BeiGene PARP Inhibitors.  At BeiGene’s request, Merck shall furnish BeiGene such information as BeiGene shall request regarding such Merck Proprietary Compound and the proposed Combination Clinical Trial.  Within [...***...] of the BeiGene’s receipt of such written notice, the Parties agree to enter into the following agreements, each of which shall contain the provisions described below, shall provide for survival in the case of a Change of Control of BeiGene, shall contain other provisions customary to agreements of that type, and shall be negotiated in good faith by the Parties.

 

2.1.                            A Clinical Trial Supply Agreement under which BeiGene shall supply BeiGene PARP Inhibitors for use in the proposed Combination Clinical Trial (including any control arm in such Combination Clinical Trial) at the [...***...] thereof during the period from the date of such agreement until the first Regulatory Approval received for the Commercialization of a BeiGene PARP Inhibitor in a Major Country. The Clinical Trial Supply Agreement will provide that if BeiGene outsources the manufacturing of the BeiGene PARP Inhibitors, BeiGene will notify Merck of the identity of the manufacturer and the pricing, and Merck will have the right to contact alternative manufacturers having the necessary capability and regulatory approvals for manufacture of BeiGene PARP Inhibitors and seek quotations for pricing of the manufacture of the BeiGene PARP Inhibitors. If Merck obtains a bona fide quotation from such a manufacturer with pricing lower than the pricing provided by BeiGene by [...***...], then BeiGene will supply the BeiGene PARP Inhibitors at the price in such quotation.

 

2.2.                            A Clinical Trial Agreement under which the Parties shall collaborate on the design of such Combination Clinical Trial (provided that Merck shall have final decision authority), Merck shall receive a non-exclusive fully paid up license to use BeiGene PARP Inhibitors in such Combination Clinical Trial and the Parties (i) shall jointly own all data generated in all Phase I Clinical Trials that are included in such Combination Clinical Trial but shall not be allowed to use the data for publication or IP filing without the prior written consent of the other Party, (ii) shall each have access to all data generated in such Combination Clinical Trial,  and (iii) shall, at the request of either Party following the last treatment of the last subject in the last Phase I Clinical Trial that is included in such Combination Clinical Trial (or earlier, upon mutual agreement of the Parties)  negotiate in good faith provisions regarding publication and intellectual property rights to all data generated in Phase II Clinical Trials and Phase III Clinical Trials included in such Combination Clinical Trial.

 

2.3.                            A Safety Data Exchange Agreement.

 

2.4.                            A Quality Assurance Agreement with respect to such Combination Clinical Trial meeting the standards of Good Clinical Practices.

 

2.5.                            A Quality Assurance Agreement with respect to the Clinical Supply Agreement meeting the standards of Good Manufacturing Practices.

 

3.                                      Miscellaneous.  This Option Agreement supersedes all proposals, negotiations, conversations and/or discussions between or among parties relating to the subject matter of this Option Agreement.  No waiver, modification or amendment of any provision of this Option Agreement shall be valid or effective unless made in a writing referencing this Option Agreement and signed by a duly authorized officer of each Party. Each Party agrees to execute, acknowledge and deliver such further instruments and to do all such other acts as may be necessary or appropriate in order to carry out the purposes and intent of this

 

*Confidential Information, indicated by [...***...], has been omitted from this filing and filed separately with the Securities and Exchange Commission.

 

 

Option Agreement.  The captions to this Option Agreement are for convenience only, and are to be of no force or effect in construing or interpreting any of the provisions of this Option Agreement.  This Option Agreement shall be governed by and interpreted in accordance with the laws of England and Wales, excluding application of any conflict of laws principles that would require application of the Law of a jurisdiction outside of England and Wales, and will be subject to the exclusive jurisdiction of the courts of competent jurisdiction located in London, England.  Any notice, request, approval or consent required or permitted to be given under this Option Agreement shall be in writing and shall be deemed to have been sufficiently given if delivered in person, transmitted by facsimile (receipt verified) or by express courier service providing evidence of delivery to the Party to which it is directed at its address or facsimile number shown in Section 9.12 of the PRC Agreement or such other address or facsimile number as such Party shall have last given by notice to the other Party.  This Option Agreement may be executed in one or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same agreement.

 

 

IN WITNESS WHEREOF, the Parties have caused this Option Agreement to be executed by their duly authorized representatives as of the Effective Date.

 

	
BeiGene, LTD
    	
Merck   KGaA
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/   John V. Oyler
    	
 
    	
By:
    	
/s/   Birgit Reitmaier
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Name:
    	
John   V. Oyler
    	
 
    	
Name:
    	
Birgit   Reitmaier
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Title:
    	
Chief   Executive Officer
    	
 
    	
Title:
    	
Head   of Technologies and Biomarkers, Global Business Development &   Alliance Management
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
By:
    	
/s/   Jens Eckhardt
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
Name:
    	
Jens   Eckhardt
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
Title:
    	
Regional   General Counsel

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