Document:

EX-10.8

 Exhibit 10.8 

ADDENDUM N° 2 TO 

EXCLUSIVE SUPPLY AGREEMENT 

for L-Asparaginase 

This Addendum is entered between: 
 ERYTECH Pharma S.A, a
company incorporated under the laws of the Republic of France (n° 479 560 013 RCS Lyon; VAT No. FR 10479560013)), having its registered head office at Bâtiment Adenine, 60 avenue Rockefeller, 69008 Lyon, France, represented by Mr
GIl Beyen, Chief Executive Officer, and by Mr Jérôme Bailly, Qualified Person, 
 hereinafter referred to as “ERYTECH
Pharma”. 
 And, 
 medac GmbH, a
company having its registered head office at Theaterstrasse 6, D22880 Wedel, Germany represented by Mr Nikolaus Graf Stolberg, Managing Director and Dr. Michaela Rehberg, Director Drug Regulatory Affairs (VAT No. DE 118579535) 

hereinafter referred to as “Medac”. 

hereinafter referred to individually or collectively as the “Parties” and individually as a “Party”. 

WHEREAS 
 The Parties have signed an Exclusive Supply
Agreement on 12th December 2008, as amended by virtue of Addendum 1 executed on 19th August 2009, (hereinafter “the
Agreement”). 
 The Parties agree to modify certain Articles of the Agreement. 

Therefore, the Agreement is hereby amended to read as follows: 
  

	1)	The exclusivity of supply set forth in Section 3.1 of the Agreement shall be converted into non-exclusivity. 

 

	2)	Section 4.3 of the Agreement shall be null and void. 

  

	3)	Section 15.1 of the Agreement shall be null and void and replaced by the following: 

“15.1. Term. 

The term of this Agreement shall commence upon the Effective Date (i.e. 10th December
2008) and unless terminated earlier or extended pursuant to this Agreement shall expire twenty (20) years thereafter (i.e. 10th December 2028). 

It is agreed between the Parties that in the event that after December 31, 2017, Medac’s supplier of the Product discontinues
in full the production of the Product for supplies to medac for the EU countries, the Agreement is suspended, including all rights and obligations of the Parties. This means that neither Party may claim or be liable for any contractual rights and/or
obligations accordingly (with exception to Article XI. Confidentiality, Article XIII. Indemnification and Article XIV. Insurance). 

It is understood between the Parties that in case the circumstance under the proceeding sentence occurs, Medac will not be deemed liable
for the lack of supply of the Product to ERYTECH Pharma according to the Agreement and ERYTECH Pharma shall not be entitled to claim any compensation, direct, indirect, incidental or consequential losses or damages howsoever caused, and whether
based on warranty, contract, tort including negligence, strict liability or otherwise from Medac. 
  

	4)	Section 15.2 of the Agreement shall be amended as follows: 

 “15.2. b):

 [...]. Such possibility of termination does not exist in case of suspension of the Agreement according to Article 15.1.
second paragraph of the Agreement. 

  
 Page 1 of 3

 “15.2. c): 

After December 31, 2017, without notice and compensation by Medac in case (a) the European Commission definitely denies the
current marketing authorisation application for GRASPA® (EMEA/H/C/004055) (the “MAA”), (b) ERYtech withdraws the
MAA or (c) ERYtech changes the MAA from using the Product to recombinant L-Asparaginase and obtains the marketing authorization relating to the changed MAA. 

 

	5)	Section 15.3 first paragraph of the Agreement shall be null and void and replaced by the following: 

“15.3. Consequences of Termination 

Except with respect to a termination by Medac pursuant to Section 15.2. b), the expiration or termination of this Agreement will not
relieve Medac from its obligation to provide with any Product to be delivered prior to the effective date of such expiration or termination.” 
  

	6)	Except as otherwise provided herein, all terms and conditions of the Agreement shall remain in full force and effect and all terms beginning by a capitalized letter shall have the same meaning as those defined in the
Agreement. 

 IN WITNESS whereof, the Parties have caused this Addendum to be executed by their duly authorized officers. 

 

					
	 ERYTECH Pharma
  
	  	
	Mr Gil Beyen	  	Place and date:	  	
	Chief Executive Officer	  		  	
		  	Lyon, July 5th, 2016	  	
	/s/ Gil Beyen	  		  	
			
	Signature	  		  	
		
	 ERYTECH Pharma
  
	  	
	Mr Jérôme Bailly	  	Place and date:	  	
	Qualified Person	  		  	
		  	Lyon, July 5th, 2016	  	
	/s/ Jérôme Bailly	  		  	
			
	Signature	  		  	
		
	 Medac
  
	  	
	Mr Nikolaus Graf Stolberg	  	Place and date:	  	
	Managing Director	  		  	
		  	Hamburg, July 15th, 2016	  	
	/s/ Nikolaus Graf Stolberg	  		  	
			
	Signature	  		  	

  
 Page 2 of 3

					
		
	 Medac
  
	  	
	ppa. Dr. Michaela Rehberg	  	Place and date:	  	
	Director Drug Regulatory Affairs	  		  	
		  	Hamburg, July 25th, 2016	  	
	/s/ Dr. Michaela Rehberg	  		  	
			
	Signature	  		  	

  
 Page 3 of 3

	B)	Execution version of Addendum 2 to the 2011 Medac AgreementEX-10.9

 Exhibit 10.9 

[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. 
 ADDENDUM N° 2 TO 

EXCLUSIVE SUPPLY AGREEMENT 

for recombinant L-Asparaginase 
 This
Addendum is entered between: 
 ERYTECH Pharma S.A, a company incorporated under the laws of the Republic of France (n° 479 560 013 RCS Lyon; VAT
No. FR 10479560013)), having its registered head office at Bâtiment Adenine, 60 avenue Rockefeller, 69008 Lyon, France, represented by Mr Gil Beyen, Chief Executive Officer, and by Mr Jérôme Bailly, Qualified Person, 

hereinafter referred to as “ERYTECH Pharma”. 

And, 
 medac GmbH, a company having its
registered head office at Theaterstrasse 6, D22880 Wedel, Germany represented by Mr Nikolaus Graf Stolberg, Managing Director and Dr. Michaela Rehberg, Director Drug Regulatory Affairs (VAT No. DE 118579535) 

hereinafter referred to as “medac”. 

hereinafter referred to individually or collectively as the “Parties” and individually as a “Party”. 

WHEREAS 
 The Parties have signed an Exclusive Supply
Agreement on 3rd May 2011, as amended by virtue of Addendum 1 executed on 4th April 2014, (hereinafter “the
Agreement”). 
 The Parties agree to modify certain Articles of the Agreement. 

Therefore, the Agreement is hereby amended to read as follows: 
  

	1)	From the date of signature of this Addendum, for the avoidance of doubt, the term “GRASPA®”, which for purposes of the Agreement, designates the
medicinal product consisting in suspension of erythrocytes encapsulating recombinant L-asparaginase and released by ERYTECH Pharma, shall also include the medicinal product, internally designated as eryasp, consisting in suspension of erythrocytes
encapsulating recombinant L-asparaginase and released by ERYTECH Pharma, which may not be commercialized under the “GRASPA®” trademark. 

 

	2)	The exclusivity obligation under Section 3.1 of the Agreement (as well as any reference to such exclusivity obligation in the Agreement) shall be in force for five years from the first supply of the Product for
commercial purposes. 

  

	3)	Section 3.3 of the Agreement shall be null and void and replaced by the following: 

  

	 	3.3	Forecast 

  

	 	•	 	ERYTECH Pharma shall provide medac with a rolling forecast of the quantities to be purchased over the next [***] (“Forecast”) of which the first [***] shall be made of quarterly projections, while the
subsequent [***] shall be made of annual projections. 

 [***] = CONFIDENTIAL TREATMENT REQUESTED 

 

	4)	Sections 4.1.1 and 4.1.2. of the Agreement shall be null and void and replaced by the following: 

“4.1. Supply price of the Product 

The price of the Product will be according to the following table: 

 

			
	  

Order volumes
	  	  

Price per Product/ Euro

	 	 
	 [***] batch

 
	  	 [***]

 

	 	 
	 [***] batch

 
	  	 [***]

 

	 	 
	 [***] batches ([***] campaign per
year which will
 run from first Firm Order (“Commercial Year”)

 
	  	 [***]

 

	 	 
	 [***] batches ([***] campaigns of
[***] batches
 per Commercial Year)
  
	  	 [***]

 

	 	 
	 [***] batches ([***] campaigns of
[***] batches
 per Commercial Year)
  
	  	 [***]

 

 It is agreed that each batch comprises a number of Products between around [***] and around
[***].” 
  

	5)	Section V of the Agreement shall be null and void and replaced by the following: 

 Article V.
MUTUAL CONSENT 
 “[***].” 
  

	6)	Section 7.1 of the Agreement shall be null and void and replaced by the following: 

“7.1. Shipment. 

Except as set out in Article 3.6 hereof and as long as the purchase orders made by ERYTECH Pharma are in compliance with the Forecast as
defined under Article 3.3 hereof, medac shall ship, directly or through any Third Party, the Product to ERYTECH Pharma to one (1) delivery destination(s) in the European Union (in case of purchase order for commercial purposes) and any delivery
destinations in the European Union (in case of purchase order for clinical purposes) specified in ERYTECH Pharma`s purchase orders within the lead-times described below, each of which will run, following the Firm Order: 

(i) [***] for [***] batch, if [***] 

 [***] = CONFIDENTIAL TREATMENT REQUESTED 

 

 (ii) [***] in case of [***] batch, if [***] 

(iii) [***] in case of [***] to [***] batches ([***] to [***] campaigns of [***] batches each) per [***], if [***] 

(iv) [***] in case of minimum [***] batches per Commercial Year, if [***] 

Pursuant to shipment of at least [***] batch, Medac shall deliver Products with [***] of the Product. 

[***]. 
  

	7)	Section 16.1 of the Agreement shall be cancelled and replaced with the following: 

“16.1. Term and termination 

The term of this Agreement shall commence upon the Effective Date and shall expire on
11th December 2028. 
 It is understood that save for the case of Force Majeure,
only following the expiration of the exclusivity period of five years as per Section 3.1 of this Agreement and only in the event that medac’s supplier of the API discontinues in full the production of the API and medac, therefore, becomes
unable to supply the Product to ERYTECH Pharma, medac will be entitled to terminate the Agreement, by sending ERYTECH Pharma a 5-years prior written notice. For the avoidance of doubt, during this 5-years notice period, medac shall remain committed
to ensure continuous supply of the Product in accordance with this Agreement.” 
  

	8)	Section 16.2 shall be cancelled and replaced with the following: 

 “16.2
Termination. The Agreement may be terminated: 
 a) without notice and compensation by the mutual written agreement of the
Parties; and 
 b) by either Party in the event a Party is in material default of the terms and conditions of this Agreement and fails to
remedy the material default within one hundred twenty (120) days after receiving written notice specifying such default.” 
  

	9)	Section XVIII below shall be added to the Agreement: 

 Article XVIII. RIGHT OF NEGOTIATION

 medac, on its behalf and on behalf of its Affiliates acknowledges, it has been informed and understood that: 

 

	 	•	 	as at the signature date of this Addendum, ERYTECH has granted to a partner with right to assign to [***] affiliates (hereinafter the “Partner”): 

 

	 	•	 	distribution and license rights with respect to a product developed by ERYTECH Pharma consisting of suspension of erythrocytes encapsulating L-Asparaginase: 

 

	 	•	 	in the 28 countries currently forming the European Union, [***]; and 

  

	 	•	 	for the ALL indication and the AML indication 

  

	 	•	 	a right of first negotiation notably in some additional territories, such as [***]. 

  

	 	•	 	In case of discrepancies between, the provisions of this Article 18 and any applicable provisions between the Partner and ERYTECH with respect to the rights granted as set out above, the provisions of this Article 18
will be modified automatically to the extent necessary to reflect what was agreed by the Partner and ERYTECH Pharma. ERYTECH Pharma shall notify medac of such modifications in writing. 

  

 [***] = CONFIDENTIAL TREATMENT REQUESTED 

 

 For the sole purpose of this Section, medac agrees and accepts that ERYTECH may disclose the existence of the
following sections to Third Parties. 
 18.1. Right of first negotiation 

In the event that within [***] of the date of this Addendum: 
  

	 	•	 	ERYTECH Pharma is no longer bound by the distribution and license rights granted to the Partner and 

  

	 	•	 	ERYTECH Pharma intends to enter into a license or other distribution arrangement with respect to GRASPA with any Third Party in relation to: 

 

	 	•	 	the 28 countries currently forming the European Union, [***] (hereinafter referred to as “Territories”); and in 

  

	 	•	 	the ALL indication and/or the AML indication (hereinafter referred to as “Indications”); 

 ERYTECH
Pharma shall notify medac of such intention in writing without undue delay. 
 18.2. Right of second negotiation 

In the event that within [***] of the date of this Addendum: 
  

	 	•	 	ERYTECH Pharma intends to enter into a license or other distribution arrangement with respect to GRASPA with any Third Party besides the Partner in relation to: 

 

	 	•	 	Turkey, Russia [***] (hereinafter referred to as “Additional Territories”); and to 

  

	 	•	 	the Indications, 

  

	 	•	 	and the Partner notifies ERYTECH Pharma that it does not wish to enter into discussions in relation to a license or other arrangement for such Additional Territories or Indications, or in the absence of any notification
by the Partner within a period mutually agreed by ERYTECH Pharma and the Partner, or if ERYTECH Pharma is no longer bound by the right of first negotiation with the Partner; 

ERYTECH Pharma shall notify medac of such intention in writing without undue delay. 

18.3. Negotiation’s proceedings 
 Within [***]
of ERYTECH Pharma’s notice to medac (within [***] if the notice falls in [***] or [***]), medac shall notify ERYTECH Pharma in writing whether it wishes to enter into discussions in relation to a license or other distribution arrangement with
ERYTECH Pharma for the Territories, Additional Territories and Indications for which medac has a right of first negotiation or second negotiation in accordance with Sections 18.1 and 18.2. If medac notifies ERYTECH Pharma that it does not wish to
enter into discussions in relation to a license or other distribution arrangement for such Territories, Additional Territories and Indications, or in the absence of any notification by medac within such period, ERYTECH Pharma shall be entitled to
enter into a license or other distribution arrangement in relation to such Territories, Additional Territories and Indications with a Third Party. 
 If
medac notifies ERYTECH Pharma that it wishes to enter into discussions in relation to a license or other distribution arrangement for such Territories, Additional Territories and indications the Parties shall negotiate exclusively in relation to the
same for a period of [***] from the response of medac. 
 If the Parties have not entered into a definitive agreement in relation to such Territories,
Additional Territories and Indications within the [***] period, ERYTECH Pharma shall be entitled to enter into a license or other distribution arrangement in relation to such Territories, Additional Territories and Indications with a Third Party
provided that the [***]. 

  

 [***] = CONFIDENTIAL TREATMENT REQUESTED 

 

 18.4 Right of information 

Without prejudice to the right of first negotiation of the Partner as described above, in the event that within [***] of the date of this Addendum: 

 

	 	•	 	ERYTECH intends to enter into a license or other distribution arrangement with respect to GRASPA with any Third Party in relation to: 

 

	 	•	 	countries where medac proves to be conducting significant distribution activities. Such countries are listed in Exhibit 4 and should be amended as the case may be by mutual agreement of the Parties; and to

  

	 	•	 	the Indications, 

 ERYTECH undertakes to inform medac of such intention in writing without undue delay. If
within [***] of ERYTECH Pharma’s notice to medac (within [***] if the notice falls in [***] or [***]), medac notifies ERYTECH Pharma that it wishes to make an offer in relation to a license or other distribution arrangement for such countries
and Indications, ERYTECH Pharma shall consider such offer in good faith but ERYTECH Pharma shall be free to enter into such license or other distribution arrangement with any Third Party. 

10) Section XIX below shall be added to the Agreement: 

“Article XIX: MUTUAL EFFORTS 
 medac
hereby authorises ERYTECH Pharma to use the information and documents related to the recombinant L-asparaginase, already provided to ERYTECH Pharma in connection with the GRASPA® registration
in ALL. 
 Without prejudice to the above, medac shall provide within a reasonable time and free of charge, ERYTECH Pharma with assistance and all the
information/documents related to the recombinant L-asparaginase available at medac and not being under confidentiality obligations towards third parties and necessary to obtain the marketing authorization of the product developed by ERYTECH Pharma
consisting of [***]. ERYTECH Pharma shall use reasonable commercial efforts to avoid any direct harm to medac. 
 If the documents/information to be
provided by medac according to the preceding sentence are under confidentiality obligations towards third parties, medac shall make reasonable efforts to obtain disclosure of said documents or information from such third parties. 

Without prejudice to the provisions of the Agreement as amended by this Addendum, ERYTECH Pharma shall [***].” 

11) In case medac wishes to carry out investment to improve the manufacturing capacity for the Product, the Parties shall promptly inform each other and send
the other Party a prospectus outlining the type of investment medac intends to make, and related costs and timeframes. Then, the Parties will discuss a possible cooperation and cost sharing, which shall not be unreasonably withheld by the Parties.

 12) Except as otherwise provided herein, all terms and conditions of the Agreement shall remain in full force and effect and all terms beginning by a
capitalized letter shall have the same meaning as those defined in the Agreement and in the Addendum n°1. 

  

 IN WITNESS whereof, the Parties have caused this Addendum to be executed by their duly authorized officers. 

ERYTECH Pharma 
  

					
	 Mr Gil Beyen
	  	Place and date:	  	
	 Chief Executive Officer
	  	Lyon, July 5th, 2016	  	
			
	 /s/ Gil Beyen
	  		  	
			
	 Signature
	  		  	
			
	 ERYTECH Pharma
  
	  		  	
	Mr Jérôme Bailly	  	Place and date:	  	
	Qualified Person	  	Lyon, July 5th, 2016	  	
			
	 /s/ Jérôme Bailly
	  		  	
			
	 Signature
	  		  	
			
	 Medac
  
	  		  	
	 Mr Nikolaus Graf Stolberg
	  	Place and date:	  	
	Managing Director	  	Hamburg, 15.7.16	  	
			
	 /s/ Nikolaus Graf Stolberg
	  		  	
			
	 Signature
	  		  	
			
	 Medac
  
	  		  	
	 ppa. Dr. Michaela Rehberg
	  	Place and date:	  	
	Director Drug Regulatory Affairs	  	Hamburg, 25.07.16	  	
			
	 /s/ Michaela Rehberg
	  		  	
			
	 Signature
	  		  	

 [***] = CONFIDENTIAL TREATMENT REQUESTED 

Execution version 
 SCHEDULE F: Update of
SCHEDULE 1.1.3 of the Agreement (List of Patents in Licensed IP) 
 [***] 

 [***] = CONFIDENTIAL TREATMENT REQUESTED 

Execution version 
  

 SCHEDULE 1.1.4: Cost items in the Supply Price calculation 

[***]

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