EX-10.21



 Exhibit 10.21 

Confidential Materials omitted and filed separately with the 

Securities & Exchange Commission. Double asterisk denote omissions. 

 
 



 
  

			
	 MorphoSys AG • Postfach 16 58 • 82145 Planegg

  Emergent Product Development Seattle, LLC

  2401 4th Ave. Suite 1050
   Seattle,
Washington 98121
	  	 MorphoSys AG
 Lena-Christ-Strabe 48
 82152 Martinsried / Planegg

Germany
 Telefon: +49 (0)89 899 27-0

Fax: +49 (0)89 899 27-222
 Email: info@morphosys.com

Internet: www morphosys.com


 CONFIDENTIAL 

19 June 2015 
 For the attention of: Site Head

 First Amendment (“First Amendment”) to the License and Co-Development Agreement (“Agreement”) dated as of August 19, 2014 and
entered into by and between 
  

	 	1.	MorphoSys AG, a German company having a place of business at Lena-Christ-Strasse 48, 82152 Martinsried/Planegg, Germany (“MorphoSys”), and 


 

	 	2.	Emergent Product Development Seattle, LLC, a Delaware limited liability corporation with offices at 2401 4th Ave. Suite 1050, Seattle, Washington 98121, USA (“Emergent”). 


This First Amendment is supplemental to the terms of the Agreement and intends to postpone certain timelines and to clarify compliance of certain obligations
of the Agreement. 
 Therefore, the Parties wish to clarify and agree on the following: 

 

	 	1.	Satisfaction of certain obligations under Section 2.1.2 of the Agreement 

 The
Parties agree that both companies used best efforts in trying to obtain the Second Third Party Manufacturing Amendment within the timeline set forth in Section 2.1.2 of the Agreement (i.e. six months after the Effective Date). MorphoSys may now
seek and obtain a direct license from Existing Manufacturing Licensor pursuant to Section 2.1.2 of the Agreement. For the avoidance of doubt, Section 2.1.2 remains in full force and effect. 

 

	 	2.	Section 4.3.3 (a) of the Agreement 

 The Parties agree to change the timeline
for approval of the Development Plan and the Development Budget from September 30th to October 31st. Therefore, Section 4.3.3 (a) of the Agreement shall be deleted in its entirety and be replaced by the following: 

  

							
	 Vorstand
 Dr Simon Moreney
(Vorsitzender)
 Jens Holstein, Dr. Arndt Schottelius
 Dr Marlies
Sproll
 Aufsichtsratsvorsitzender
 Dr. Gerald
Möller
	 	 Bankverbindungen
 HypoVereinsbank
München
 BLZ 700 202 70
 Kto. 419 482 56

IBAN DE55 7002 0270 0041 9482 56
 SWIFT (BIC): HYVEDEMMXXX
	  	Deutsche Sank
 BLZ 700 700 10
 Kto. 200
221 000
 IBAN: DE11 7007 0010 0200 2210 00

SWIFT (BIC): DEUTDEMM
	  	St.-Nr.
 9143/101/21259

Handelsregister:
 München HRB 121023

VAT-ID. No:
 DE 15506 9821











 



 
  


                “(a) On or before
October 31st of each year during the Term, the JSC shall review, update and approve the Development Plan (including the Development Budget contained therein) which shall cover the Development Activities to be conducted during the upcoming
Calendar Year, and the JSC shall, on at least an annual basis, review and update, as appropriate, the then-current Development Plan (including the Development Budget) to reflect any changes, reprioritizations of, or additions to the Development
Plan; provided, however, that any disputes with respect thereto shall be resolved pursuant to Sections 3.4 and 3.5.” 
  

	 	3.	Section 5.4.1 of the Agreement 

 The Parties acknowledge the JSC approval of the
clinical safety reporting plan (file named “Clinical Safety Reporting Plan MOR209/ES414 Protocol: 401,” final version 1.0), approved by team members of both Parties and effective as of November 05th, 2014, complies with the
requirements set forth in Section 5.4.1 of the Agreement in regard to the execution of a pharmacovigilance agreement prior to first dosing of the first patient in the first Clinical Trial. In addition, the JSC has agreed as required in
Section 5.4.1 of the Agreement that Emergent will maintain the global safety database for the Product for the current stage of clinical development. 
  

	 	4.	Section 6.5 of the Agreement 

 The following language shall be added at the end of
Section 6.5.1. 
 The Parties clarify and acknowledge that their policies and internal guidelines may be updated from time to time and
that currently it is not feasible to provide the guidelines for trademark usage valid at the time of creation of Promotional Materials. The Parties agree to exchange the valid guidelines for trademark usage before the creation of Promotional
Material. Except as provided herein, Section 6.5 of the Agreement shall remain unaffected in its entirety. 
  

	5.	Section 7.5 of the Agreement 

 The Parties agree to postpone the timeline for
execution of the quality agreement for development supply of the Product until July 31, 2015. The Parties also agree that, in the interest of complying with all Laws, internal controls, and the requirements of Section 7.5, an additional
document (Quality Technical Agreement) will be executed by the Parties not later than August 31, 2015 setting forth the roles and responsibilities of each Party relative to those activities related to but not covered by the Quality
Agreement. Therefore, Section 7.5 of the Agreement shall be deleted in its entirety and be replaced by the following: 

“7.5 Quality Agreements. The Parties shall execute a (i) Quality Agreement for development supply of the
Product not later than July 31st, 2015 and (ii) a quality agreement for commercial supply of the Product within ninety (90) calendar days of execution of the Supply Agreement, which shall set forth the Parties’ quality and
compliance obligations with respect to Manufacture of the Finished Product (both quality agreements, the “Quality Agreements”). MorphoSys and Emergent agree to comply with the requirements and provisions set forth in the Quality
Agreements.” 

  
 Letter Agreement MorphoSys/Emergent June
18, 2015 
 - 2 - 









 



 
  

 For purposes of this Agreement “Quality Agreement” shall mean a legally
binding agreement that establishes the obligations and responsibilities of the quality units of the Parties. The Quality Agreement for development supply is established for clinical phase MorphoSys-sponsored activities and does not apply to
commercial supply. The Quality Agreement describes which cGMP activities will be carried out by each Party per applicable regulations and defines in detail the GMP responsibilities, including the quality measures, of each Party. 

7.5.1 Quality Technical Agreements. The Parties shall execute a (i) Quality Technical Agreement for development
supply of the Product not later than August 31st, 2015 and (ii) quality technical agreement for commercial supply of the Product within ninety (90) calendar days of execution of the Supply Agreement, which shall set forth the
Parties’ quality and compliance obligations with respect to Manufacture of the Finished Product not otherwise covered by the Quality Agreements (both quality technical agreements, the “Quality Technical Agreements”). MorphoSys
and Emergent agree to comply with the requirements and provisions set forth in the Quality Technical Agreements.” 
 For purposes of
this Agreement “Quality Technical Agreement” shall mean a legally binding agreement that describes which cGMP activities will be carried out by Emergent and MorphoSys for clinical phase Emergent-sponsored activities per applicable
regulations and defines in detail the GMP responsibilities, including the quality measures, of each Party. The Quality Technical Agreement for development supply is established for all clinical phase activities and does not apply to commercial
supply. 
  

	 	6.	Section 8.12 of the Agreement 

 The Parties agree to correct a deviation of the
stated FTE rate in numbers from the one in words. Therefore, Section 8.12 of the Agreement shall be deleted in its entirety and be replaced by the following: 

“8.12 FTE Costs. With respect to those costs under Article 4 and Article 5 or with respect to costs for which this
Agreement expressly refers to this Section 8.12 which a Party is obligated to bear internally and then submit to the other Party for sharing, or reimbursement, as the case may be, each Party shall calculate its internal costs using an FTE rate
of [**] Dollar ($[**]) per year. The FTE rate covers employee salary, employee specific benefits, travel costs and materials. After the [**] anniversary of the Effective Date, the FTE rates shall be subject to adjustments to reflect changes in the
Producer Price Index for the Pharmaceutical Sector as reported by the U.S. Bureau of Labor Statistics for the previous twelve (12) months.” 

  
 Letter Agreement MorphoSys/Emergent June
18, 2015 
 - 3 - 









 



 
  


	 	7.	Section 16.3 of the Agreement 

 The language currently reading: 

                    
“and to: 
 Emergent BioSolutions Inc. 

2273 Research Blvd., Suite 400 

Rockville, MD 20850 

Attention: General Counsel 

Fax: [**]” 

shall be deleted in its entirety and replaced by the following: 

                    
“and to: 
 Emergent Biosolutions Inc. 

400 Professional Drive, Suite 400 

Gaithersburg, MD 20879 

Attention: General Counsel 

e-Fax: [**]” 

[Remainder of page intentionally left blank, signatures follow on next page] 

  
 Letter Agreement MorphoSys/Emergent June
18, 2015 
 - 4 - 









 



 
  

 The terms of the Agreement continue in full force and effect and unchanged except to the
extent clarified above. 
 Please indicate Emergent’s acceptance and agreement to this First Amendment by arranging for authorized
representatives of Emergent to sign both copies of this First Amendment and returning one signed original to MorphoSys. 
  

			
	MorphoSys AG	  	
		
	/s/ Dr. Arndt Schottelius                                	  	/s/ Dr. Marlies Sproll                                
	 Dr. Arndt Schottelius
 Chief Development
Officer
	  	 Dr. Marlies Sproll
 Chief Scientific
Officer

		
	 AGREED and ACCEPTED on behalf of Emergent:

Emergent Product Development Seattle,
 LLC
	  	

  

							
	(signature)	  	(signature)
	Name:	  	/s/ [Illegible]                        	  	Name:	  	/s/ [Illegible]                            
	Title/Position:	  	CMO, SVP	  	Title/Position:	  	S. VP & CSO
	Date:	  	7/7/2015	  	Date:	  	7/8/15

 cc. Emergent BioSolutions Inc. (General Counsel) 

      Morgan, Lewis & Bockius LLP ([**]) 

  
 Letter Agreement MorphoSys/Emergent June
18, 2015 
 - 5 - 









							
		  		  	MorphoSys AG
		  		  	Lena-Christ-Strße 48
		  		  	82152 Martinsried / Planegg
			
	MorphoSys AG • Postfach 16 58 • 82145 Planegg	  		  	Germany
				
		  		  	Telefon:	  	+49 (0)89 899 27-0
	Emergent Product Development Seattle, LLC	  		  	Fax:	  	+49 (0)89 899 27-222
	2401 4th Ave. Suite 1050	  		  	Email:	  	info@morphosys.com
	Seattle, Washington 98121	  		  	Internet:	  	www.morphosys.com

 CONFIDENTIAL 

Letter Extension Term Development Plan 2016 

October 27, 2015 
 For the attention of: Site
Head 
 Reference is made to the License and Co-Development Agreement dated as of August 19, 2014, as amended by first amendment dated June 19,
2015 (“Agreement”), entered into by and between MorphoSys AG, (“MorphoSys”), and Emergent Product Development Seattle, LLC, (“Emergent”) 

Emergent and MorphoSys intend to extend the timeline set forth in Section 4.3.3 (a) of the Agreement, to review, discuss and approve the Development
Plan for the year 2016, therefore the Parties agree on the following: 
 Solely with respect to the Development Plan (including the Development Budget
contained therein) for the year 2016, the Parties agree to extend the timeline to review, discuss and approve such 2016 Development Plan from October 31st, 2015 to December 28th, 2015. 
 All other terms of the Agreement shall remain unchanged and, except for the specific timeline
extended hereby, the Agreement, including Section 4.3.3 shall continue in full force and effect. This Letter Agreement is supplemental to the Agreement. In the event of any conflict or inconsistency between the Agreement and this Letter
Agreement with respect to the timeline extended hereby, the latter shall prevail. This Letter Agreement shall become effective upon Emergent’s countersignature below. 

If the foregoing terms are agreeable to Emergent, please countersign and date this letter here below and return the original to MORPHOSYS. 

 

							
	Vorsand	  	Bankverbindungen	  	Duetsche Bank	  	St.-Nr.
	Dr. Simon Moroney (Vorsitzender)	  	BayemLB	  	BLZ 700 700 10	  	9143/101/21259
	Jens Holstein, Dr. Arndt Schottelius	  	BLZ 700 500 00	  	Kto. 200 221 000	  	Handelsregister:
	Dr. Marlies Sproll	  	Kto. 1259861	  	IBAN: DE11 7007 0010 0200 2210 00	  	München HRB 121023
	Aufsichtsratsvorsitzender	  	IBAN: DE59 7005 0000 0001 259861	  	SWIFT (BIC): DEUTDEMM	  	VAT-ID. No:
	Dr. Gerald Möller	  	SWIFT (BIC): BYLADEMMXXX	  		  	DE 15506 9821









									
	With kind regards	 		  	
			
	MorphoSys AG	 		  	
			
	(i.A, i.V.)	 		  	(i.A, i.V.)
			
	Name	 		  	Name
	Function or Department	 		  	Function or Department
			
	AGREED and ACCEPTED on behalf of	 		  	
	Emergent:	 		  	
	Emergent Product Development Seattle, LLC	 		  	
					
	(signature)	 		 		  	(signature)	  	
	Name:	 	 /s/ Scott C. Stromatt
	 		  	Name:	  	 /s/ W. James Jackson

	Scott C. Stromatt	 		  		  	
	Title/Position:	 	SVP CMO	 		  	Title/Position:	  	SVP, CSO
					
	Date:	 	10/29/2015	 		  	Date:	  	11/04/15

  

							
	Vorsand	  	Bankverbindungen	  	Duetsche Bank	  	St.-Nr.
	Dr. Simon Moroney (Vorsitzender)	  	BayemLB	  	BLZ 700 700 10	  	9143/101/21259
	Jens Holstein, Dr. Arndt Schottelius	  	BLZ 700 500 00	  	Kto. 200 221 000	  	Handelsregister:
	Dr. Marlies Sproll	  	Kto. 1259861	  	IBAN: DE11 7007 0010 0200 2210 00	  	München HRB 121023
	Aufsichtsratsvorsitzender	  	IBAN: DE59 7005 0000 0001 259861	  	SWIFT (BIC): DEUTDEMM	  	VAT-ID. No:
	Dr. Gerald Möller	  	SWIFT (BIC): BYLADEMMXXX	  		  	DE 15506 9821