Document:

EX-10.61

 Exhibit 10.61 

[***] Indicates that information has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions. 
 SUPPLY AND LICENSE AGREEMENT 

BETWEEN 
 GEMA Biotech S.A. 

San Vladimiro 3056, San Isidro, 

Province of Buenos Aires, Argentina 

AND 
 Serendex ApS 

CVR 3053 2228 
 Slotsmarken 12,1

 2970 Horsholm 
 Denmark 

 [***] Indicates that information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions. 
 CONTENTS 

 

							
	1.	 	DEFINITIONS	  	 	1	  
			
	2.	 	LICENSES	  	 	4	  
			
	3.	 	LICENSE FOR A TECHNICAL TRANSFER AND SELLING OF THE MASTER CELL BANK	  	 	4	  
			
	4.	 	RIGHT OF FIRST REFUSAL	  	 	5	  
			
	5.	 	EXCLUSIVITY	  	 	5	  
			
	6.	 	SUPPLY OF PRODUCTS	  	 	6	  
			
	7.	 	FORECAST	  	 	6	  
			
	8.	 	PURCHASE ORDER	  	 	6	  
			
	9.	 	PRICING AND ROYALTY	  	 	6	  
			
	10.	 	MANUFACTURE, RESEARCH AND DEVELOPMENT	  	 	7	  
			
	11.	 	INTELLECTUAL PROPERTY RIGHTS	  	 	7	  
			
	12.	 	TRADEMARK AND DESIGN	  	 	8	  
			
	13.	 	REGULATORY DOCUMENTATION	  	 	8	  
			
	14.	 	QUALITY AGREEMENT	  	 	9	  
			
	15.	 	CONFIDENTIAL INFORMATION	  	 	9	  
			
	16.	 	REPRESENTATIONS AND WARRANTIES	  	 	10	  
			
	17.	 	LIABILITY AND INDEMNIFICATION	  	 	10	  
			
	18.	 	TERM AND TERMINATION	  	 	11	  
			
	19.    	 	MISCELLANEOUS	  	 	11	  

 [***] Indicates that information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions. 
 SUPPLY AND LICENSE AGREEMENT 

BETWEEN 
 GEMA Biotech S.A. 

San Vladimiro 3056, San Isidro, 
 Province of Buenos Aires,
Argentina 
 (hereinafter referred to as “GEMA”) 

AND 
 Serendex ApS 

CVR 3053 2228 
 Slotsmarken 12,1 

2970 Horsholm 
 Denmark 

(hereinafter referred to as “Serendex”) 
 GEMA and
Serendex are referred to herein as a “Party” and collectively as the “Parties”. 
 PREAMBLE 

Whereas: 
  

	 	•	 	GEMA is a highly experienced company within the area of production of biopharmaceutical products including the Active Pharmaceutical Ingredients (API), and 

 

	 	•	 	GEMA is also producing finished product from the Active Pharmaceutical Ingredient 

  

	 	•	 	Serendex is in the business of research and development, distribution, commercialization and marketing of medicinal products, and 

  

	 	•	 	Serendex is interested in purchasing supplies of an Active Pharmaceutical Ingredient for the research and development, distribution, commercialization and marketing thereof, in the Territory, of the potentially Final
Product developed by Serendex from de API, and potentially exploit a license to manufacture API. 

 The Parties have decided to enter into
this Supply and License Agreement concerning the Active Pharmaceutical Ingredient on the terms set out below: 
  

	1.	DEFINITIONS 

 “Affiliate” of a Party shall mean any company or legal entity, which is
owned or controlled directly or indirectly by such Party. For the purpose of this clause, “control” shall mean ownership of more than fifty percent (50%) of the equity ownership and/or the power to direct, to cause the direction of the
management and policies of such legal entity. 
 “Agreement” shall mean this Supply and License Agreement, including its appendices. 

 [***] Indicates that information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

 “Active Pharmaceutical Ingredient” or “API” shall mean GEMA recombinant
human Granulocyte-Macrophage Colony-Stimulating Factor (rhGM-CSF) obtained from the [***] meeting all the API Specifications mutual agreed by the parties. The amino acid sequence of rhGM-CSF is identical to the natural molecule but it is
non-glycosylated. The molecular weight is 14.5 kD, and the API is formulated as a concentrated solution as set out in Appendix 1. 

“Applicable Law” shall mean the law set out in Article 19.5. 

“API Specifications” shall mean the specifications set out in Appendix 2. 

“Batch Records” shall mean the formal set of instructions for the cGMP production of each Lot of API. 

“Certificate of Analysis” shall mean an authenticated document, issued by an appropriate authority that certifies the quality and purity of
pharmaceutical APIs. 
 “Confidential Information” shall mean any and all technical or commercial information which is now or at any time
hereafter during the term of this Agreement in the possession of either Party or its Affiliates and is derived from the other Party or that other Party’s Affiliates which is of a confidential nature or is received under circumstances which the
receiving Party knows or should know that the information is confidential, including without limitations any data, know-how, formulae, processes, designs, photographs, drawings, specifications and samples and
any other material bearing or incorporating any such information together with any financial or commercial information relating to the business of a Party. 

“CMC Biologics” shall mean the biopharmaceutical manufacturing and development organization registered under ttle laws of Denmark under
company registration number (CVR): 2595 0941. 
 “CMO” shall mean GEMA or a Contract Manufacturing Organisation appointed by either party
that is able to produce recombinant proteins of cGMP quality according to the API specifications. 
 “Current Good Manufacturing Practices”
or “cGMP” shall mean the current Good Manufacturing Practices and standards for the manufacture, testing, filling and or preparation for delivery of the API pursuant to the Guidelines accepted, recognized and issued by
Argentina’s Health Authorities for good manufacturing practices for medicinal products for human use and the ICH Q7A guidelines as formally included into the EU GMP regulations as “Part II - Basic Requirements for Active Substances used as
Starting Materials”. 
 GEMA’s current site of API manufacturing has been audited by an international recognized Qualified Person on April 24th,
2012 and April 25th, 2012 and found, that GEMA’s site currently complies with ICH Q7A guidelines as formally included into the EU GMP regulations as “Part II - Basic Requirements for Active Substances used as Starting Materials”. 

“Delivery Date” shall mean the date of handing over ordered API or Finished Product to the first carrier as chosen by Serendex. 

“Effective Date” shall mean the date of signature of the last of the Parties hereto. 

  
 -2- 

 [***] Indicates that information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

 “Field” shall mean any disease /diagnosis to be treated by inhalation and/or local pulmonary
administration and/or parenteral administration and/or local administration with the agreed API / FP. 
 “Finished Product” (FP) shall mean
any pharmaceutical formulation of the API in a defined embodiment (vial, syringe or other devises including stoppers, liners and caps as applied). See Appendix 3. 

“GEMA Know-How” shall mean any and all know-how directly
relating to the specific manufacture of the API and Finished Product listed in Appendix 4 including the Master Cell Bank and the Working Cell Bank. 

“Lot” shall mean a “Bulk Lot”, “Filling Lot” or “Packaging Lot”. A Bulk Lot shall mean the
quantity of uniform API material identified by GEMA as having been manufactured in one batch fermentation. A Filling Lot shall mean the group of final containers identical in all respects, which have been filled with the same Finished Product from
the same Bulk Lot without changes that will affect the integrity of the filling assembly. Packaging Lot shall mean the uniform quantity of final containers derived from a single Filling Lot. 

“Master Cell Bank” shall mean the cell bank from which the Working Cell Bank has been derived, manufactured a d characterized and stored as
described in ICH guideline Q5B and as set out in Appendix 5. 
 “Net Sales” shall mean, for the purposes of calculating royalties,
in any case where a Product is sold or commercially disposed of for value by Company or its Affiliate in an arm’s length transaction with a third party (other than an Affiliate of Company) in the Territory, the gross invoice price for such
Product: 
 less the following: 
  

	 	•	 	discounts, coupons, rebates, and co-operative advertising allowances, directly identifiable to the Product, to purchasers actually taken or allowed, which are consistent with the
normal business practices of Company across its product line; 

  

	 	•	 	credits or allowances given or made for rejections or return of any previously sold Products (for which a royalty has already been paid) actually taken or allowed, which are consistent with the normal business practices
of Company across its product line; 

  

	 	•	 	to the extent included in such gross invoice price and actually paid by Company, any tax or government charge imposed on the production, import, export, sale, delivery or use of such Products, including, without
limitation, any value added or similar tax or government charge, but not including any tax levied with respect to income; 

  

	 	•	 	to the extent included in such gross invoice price, any shipping or freight charges for delivery to the third-party purchaser, to the extent that such shipping charges are consistent with the normal business practices
of Company across its product line; and 

  

	 	•	 	notwithstanding any other provision in this Agreement, Net Sales shall not include the transfer/use without consideration of any Product by Company: 

for use in any clinical trial or in any pre-clinical or other research; 

  
 -3- 

 [***] Indicates that information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

 as samples or other use to promote additional Net Sales in amounts consistent with the
normal business practices of Company across its product line; or 
 for compassionate use. 

The sale of a single unit of Product may be considered only once in calculating Net Sales. 

“Process Change Request” shall mean a document that describes any proposed change or modification to one or more of the API Specifications,
excipients, a process or equipment but not limited to use during the manufacturing process. 
 “Regulatory Information” shall mean without
limitation any and all data relating to the quality and safety of the API including pharmaceutical/technical information (including description of facilities, equipment and processes, process and methods validation data, stability programs and
stability data, analytical methods, etc.), and pharmacological, data. 
 “Serendex IP” shall mean the
know-how and intellectual property rights described and listed in Appendix 11 as amended by the sole discretion of Serendex from time to time. 

“Term and Termination” shall for the purpose of this Agreement have the meaning set out in Article 18. 

“Territory” shall mean the entire world except Latin America, Mexico and Central America. 

“Working Cell Bank” shall mean the cell bank as set out in Appendix 6 from which the API is manufactured. 

 

	2.	LICENSES 

  

	2.1	Subject to the terms of this Agreement, GEMA hereby grants Serendex exclusive license for free with and unlimited right to sublicense within the Field to use and in any way exploit GEMA
Know-How and to market, distribute and sell Finished Products and medicinal products based upon the Active Pharmaceutical Ingredient in the Territory. 

 

	2.2	The information related to the API is and will always be the property of GEMA. All relevant information requested from any authorities shall be provided without undue delay by GEMA to Serendex without any cost for
Serendex. 

  

	3.	LICENSE FOR A TECHNICAL TRANSFER AND SELLING OF THE MASTER CELL BANK 

  

	3.1	No later than 6 month after the effective date GEMA Biotech is obliged to make a deposit of a copy of the Master Cell Bank (here and after “the Back-up Master Cell
Bank”) at CMC Biologics in Herlev, Denmark (www.cmcbio.com) who on their site offer cGMP Cell Banking. The scope is for CMC only to serve as back up for both parties. The deposit will be in the name of GEMA Biotech. Serendex shall bear the
maintenance and stock costs. 

  
 -4- 

 [***] Indicates that information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

	3.2	If for any reason whatsoever GEMA cannot fulfil the obligations set forth in the present Agreement and Serendex is forced to establish its own production, the ownership of the
Back-up Master Cell Bank is transferred free of charge to Serendex and Serendex will have the right to produce GM-CSF API on the following conditions: 

 

	 	a.	Serendex pays to GEMA [***] for the Technology transfer, Technical information and Technical support ensuring that Serendex is able to set up its own cGMP GM-CSF production. [***]
is due when the first batch has been successfully produced (cGMP - GM-CSF). 

  

	 	b.	GEMA continues to receive the royalties according to the present contract and keep the agreed geographically territory. GEMA shall buy FDF from Serendex. 

 

	3.3	If for any reason whatsoever GEMA after the period set out in Article 18.3 does not want to produce cGMP GM-CSF or GEMA and Serendex agree that Serendex can set up a parallel
production and Serendex shall have right to take over the Back-up Master Cell Bank on the following conditions: 

  

	 	a.	The ownership of the Back-up Master Cell Bank is transferred to Serendex. For this Serendex pays to GEMA [***] whereof [***] is paid upfront and [***] when the first batch has
been successfully produced (cGMP - GM-CSF). 

  

	 	b.	Serendex pays to GEMA [***] for the Technology transfer, Technical information and Technical support ensuring that Serendex is able to set up the cGMP GM-CSF production. The
amount is due when the first batch has been successfully produced (cGMP - GM-CSF). 

  

	 	c.	GEMA continues to receive the royalties according to the present contract and keep the agreed geographically territory. GEMA shall buy FDF from Serendex. 

 

	4.	RIGHT OF FIRST REFUSAL 

  

	4.1	Serendex is granted first right of refusal for all the FP products that GEMA might produce from the cGMP GM-CSF API and a firm contract will be outlined and signed accordingly.

  

	5.	EXCLUSIVITY 

  

	5.1	The Parties have agreed that GEMA or a company appointed by GEMA shall be the exclusive supplier of the Active Pharmaceutical Ingredient to Serendex for research, development, use, distribution and marketing within the
Field and within the Territory, and Serendex undertakes only to purchase Active Pharmaceutical Ingredient from GEMA. 

  

	5.2	Furthermore the Parties have agreed that GEMA undertakes within the Field and within the Territory to supply the Active Pharmaceutical Ingredient exclusively to Serendex. If GEMA produces Finished Product containing the
Active Pharmaceutical Ingredient, as pointed out in the previous paragraph, GEMA shall only supply Finished Product containing the Active Pharmaceutical Ingredient exclusively to Serendex, for which a specific contract will be entered into by both
Parties. 

  
 -5- 

 [***] Indicates that information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

	6.	SUPPLY OF PRODUCTS 

  

	6.1	GEMA undertakes to supply Serendex with its entire need for the Active Pharmaceutical Ingredient for research, development, sales, marketing, distribution, import and export. 

 

	6.2	Each shipment of the Active Pharmaceutical Ingredient shall be accompanied by a Certificate of Analysis documenting that the Active Pharmaceutical Ingredient is meeting the Specifications and has been manufactured in
accordance with cGMP and the Batch Records. All Active Pharmaceutical Ingredient shipped to Serendex must have a residual shelf life of at least [***] at the time of delivery. 

 

	6.3	It will be Serendex’s exclusive obligation to obtain the necessary import permits for the Active Pharmaceutical Ingredient before the relevant health and customs authorities and/or any other relevant authority.
GEMA undertakes to do its outmost within its power and in any way cooperate in order to obtain such permits. 

  

	6.4	The Active Pharmaceutical Ingredient will be delivered ex works Inco Terms. 

  

	7.	FORECAST 

  

	7.1	The Parties agree that Serendex, shall submit a forecast to GEMA for its need of the Active Pharmaceutical Ingredient no later than 8 weeks from effective date valid for the rest of the year. Thereafter, Serendex shall
submit a forecast every year in the month of October covering Serendex’s need of the Active Pharmaceutical Ingredient in the following calendar year. 

  

	7.2	The forecast may be amended from time to time by mutual agreement. 

  

	7.3	The forecast as set out in Appendix 9 and which shall be updated each year in October constitutes Serendex’s minimum purchase obligation of the Active Pharmaceutical Ingredient according to this Agreement.

  

	8.	PURCHASE ORDER 

  

	8.1	Serendex undertakes to place its purchase orders for the Active Pharmaceutical Ingredient in writing no later than 120 days prior to the desired Delivery Date. All purchase orders shall be confirmed in writing by GEMA
within 10 working days of receipt. 

  

	8.2	GEMA undertakes to fulfil the orders of Serendex for the Active Pharmaceutical Ingredient within 120 days of confirmation of an order. Products shall be delivered to a Serendex appointed facility in Denmark or such
other place as instructed by Serendex. 

  

	9.	PRICING AND ROYALTY 

  

	9.1	Serendex is entitled to order the Active Pharmaceutical Ingredient for research and clinical studies and compassionate use. Such material shall be provided at a mutual agreed net price. Payment shall take place no later
than 180 days after Delivery Date. 

  
 -6- 

 [***] Indicates that information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

	9.2	As regards orders for the Active Pharmaceutical Ingredient for commercial sales and use in approved medicinal products Serendex shall pay GEMA a mutual agreed net price per vial of 1 gram as set forth in Appendix
12. Delivered ex works inco terms. The price for vials containing other amounts of the Active Pharmaceutical Ingredient than 1 gram shall be adjusted in proportion hereto. 

 

	9.3	If Serendex successfully develops and registers within the proper Health Authorities in any Country of the Territory a Final Product for human use with the API, Serendex will pay a royalty covering Finished Products for
commercial sales and use in approved medicinal products, which is established below from its annual Net Sales in the Territory. The parties have agreed that there shall be no minimum royalty, no signing fee or milestones included in the royalty
payments: 

  

					
	 Net Sales US $
	  	Royalty of Net Sales	 
	 < 100 million
	  	 	[***	] 
	 100 million - 250 million
	  	 	[***	] 
	 250 million - 500 million
	  	 	[***	] 
	 > 500 million
	  	 	[***	] 

  

	9.4	Within 60 days after the expiry of a calendar year, Serendex shall report the Net Sales of the previous year and pay the royalties on Net Sales as set out in article 9.3. 

GEMA will have the right to audit Serendex’s selling numbers, figures and books. 

This Royalty shall not be applicable if the present Agreement is terminated and Serendex decides not to exercise its right under Article 3,
above (License of Technical Transfer and Selling of Master Cell Bank). 
  

	10.	MANUFACTURE, RESEARCH AND DEVELOPMENT 

  

	10.1	GEMA undertakes to notify Serendex of Process Change Requests or changes to the facilities or equipment etc. with 60 days prior written notice. If such changes may influence on the regulatory status of the Active
Pharmaceutical Ingredient GEMA is not entitled to implement the changes without the prior written acceptance from Serendex. 

  

	11.	INTELLECTUAL PROPERTY RIGHTS 

  

	11.1	Serendex IP includes know-how related to the Active Pharmaceutical Ingredient and Finished Product and the Field, and will therefore to some extent be overlapping with GEMA Know-How. The Parties have acknowledged and accepted this. 

  

	11.2	Serendex IP remains the sole and exclusive property of Serendex and nothing in this Agreement shall be construed as a grant of license or any other rights over Serendex IP. Serendex is solely responsible for filing,
prosecuting, maintaining and defending the Serendex IP. Consequently, Serendex is liable to pay any costs and expenses relating to prosecuting, maintaining and defending Serendex IP. 

  
 -7- 

 [***] Indicates that information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

	11.3	The Parties agree that to the extent possible any and all know-how, patents and other intellectual property rights generated during this Agreement shall be solely owned by
Serendex and Serendex shall be solely responsible for filing, prosecuting, maintaining and defending such developed intellectual property rights at its own cost. 

  

	11.4	GEMA undertakes to refrain from taking actions of any nature whatsoever that might damage Serendex reputation, name or jeopardize Serendex IP. 

 

	12.	TRADEMARK AND DESIGN 

  

	12.1	In respect of trademarks and designs it is separately noted that Serendex shall perform, research, development, distribution, commercialization and marketing of Finished Products and medicinal products based on the
Active Pharmaceutical Ingredient with its own registered or unregistered trademarks as well as with Serendex’s own packaging design. Nothing in this clause prevents Serendex from selling the developed FP in white labelling. 

 

	12.2	Any such trademarks and/or design used by Serendex are and remain the exclusive property of Serendex. GEMA acknowledges that any use of such trademarks and designs require the prior written approval of Serendex.

  

	13.	REGULATORY DOCUMENTATION 

  

	13.1	Regulatory update shall take place at least every year with a copy of the API batch records and release documentation in the form of Certificate of Analysis according to specifications shall be delivered no later than 1
month after release of batch. 

  

	13.2	GEMA undertakes to provide Serendex with all reasonable assistance in Serendex’s efforts to obtain regulatory approval/marketing authorizations for Finished Products/medicinal products based on the Active
Pharmaceutical Ingredient with the relevant national and international regulatory authorities. GEMA shall provide Serendex with access to ifs biologic license applications and other relevant files including site master files as may be amended from
time to time. 

  

	13.3	GEMA shall support Serendex in developing an Investigator Brochure (IB) for the API and Finished Product and at all times keep Serendex current of any changes and revisions. Serendex shall keep GEMA informed of any
studies that is to be incorporated into the 1B and supply the appropriate information to GEMA. GEMA is only entitled to use the results of any such studies performed by Serendex or third parties on behalf of Serendex with Serendex prior written
consent. If required for obtaining regulatory approval or otherwise satisfy demands from public authorities, Serendex shall upon request have access to all underlying raw data, analysis and reports from CMC development, preclinical and clinical
studies. 

  
 -8- 

 [***] Indicates that information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

	14.	QUALITY AGREEMENT 

  

	14.1	The manufacturing of Active Pharmaceutical Ingredient and Finished Products shall take place in full compliance with the Active Pharmaceutical Ingredient Specifications, the Quality Agreement set out in Appendix
10 and the cGMP rules and other applicable local regulations (environmental, safety regulations etc.), including any and all amendments to these regulations which are effective during the term of the Agreement. 

 

	14.2	All Active Pharmaceutical Ingredient and Finished products supplied under this Agreement is subject to Serendex release testing and Serendex inspection prior to acceptance. Serendex shall use best effort to complete
such inspection within thirty (30) days from date of receipt of Active Pharmaceutical Ingredient. Serendex reserves the right to reject any Lot of Active Pharmaceutical Ingredient or subdivision thereof by reason of the failure of such Lot to
meet any applicable specification or standard as set forth in the this Agreement, including but not limited to the Active Pharmaceutical Ingredient Specifications. 

 

	14.3	GEMA must retain samples of Active Pharmaceutical Ingredient under storage conditions appropriate to assure stability and quality of the Active Pharmaceutical Ingredient for a period of at least [***] from the
manufacturing date. 

  

	14.4	The Parties undertake to notify each other in writing of any reports of adverse drug events with respect to the API/finished products or medicinal products based on the Active Pharmaceutical Ingredient which comes to
either Party’s knowledge, regardless of the origin of such reports. 

  

	14.5	In order to ensure continued compliance with the provisions of this Agreement and cGMP, Serendex reserves the right to perform inspections and audits of GEMA’s documentation, procedures, capabilities and facilities
anywhere in the world at any time with 90 (ninety) days’ prior written notice. GEMA undertakes to use its best efforts to facilitate such audits and to provide any relevant and necessary information and documentation. 

 

	15.	CONFIDENTIAL INFORMATION 

  

	15.1	During the term of this Agreement, and for five (5) years thereafter, each Party shall maintain in strict confidence any and all Confidential Information disclosed to it by the other Party pursuant to this
Agreement. Each Party agrees that it shall not use for any purpose other than the purposes expressly contemplated under this Agreement and shall not disclose to any third party the Confidential Information of the other Party. A Party’s
employees shall sign a confidentiality statement, which wording must be approved by the other Party, before such employees get access to Confidential Information of the other Party. 

 

	15.2	The confidentiality obligations of Article 15.1 shall not apply to: 

  

	 	1)	information which is or becomes known publicly through no fault of the Receiving Party; 

  

	 	2)	information learned by the Receiving Party from a third party entitled to disclose it; 

  

	 	3)	Information already known to the Receiving Party before the Disclosing Party disclosed the Confidential Information as shown and documented by written records. 

  
 -9- 

 [***] Indicates that information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

	15.3	Confidential Information which is required to be disclosed by law or any regulatory or government authority, provided however, if a Party becomes legally compelled to disclose any Confidential Information, that the
Receiving Party promptly consult with the Disclosing Party as to the reasons for such disclosure, and attempt to afford the Disclosing Party a reasonable opportunity to obtain a protective order as to such Confidential Information, and will use
reasonable efforts to obtain reliable assurance that such Confidential Information will be treated confidentially. 

  

	16.	REPRESENTATIONS AND WARRANTIES 

 Each Party warrants to the other that: 

 

	16.1	it is a corporation duly organised, validly existing and in good standing under the laws of their respective constitution; 

  

	16.2	it has the full and unrestricted power and authority to enter into this Agreement, to perform the activities under this Agreement and to disclose Confidential Information for the purpose of this Agreement; and

  

	16.3	as of the Effective Date of this Agreement, it has no conflicting third-party agreements, and it shall not enter into any third-party agreements during the term of this Agreement that would prevent or interfere with its
performance of its obligations hereunder. 

  

	17.	LIABILITY AND INDEMNIFICATION 

  

	17.1	Serendex agrees to defend, indemnify, and hold harmless GEMA and its respective employees, officers, directors (collectively “GEMA’s Indemnities”) against and from any damages or losses resulting from
third party claims, proceedings or investigations caused by (a) any negligent actions or wilful misconduct of Serendex or its Affiliates or (b) any violation of law or regulation by Serendex or its Affiliates, provided that Serendex shall
have no obligation to indemnify any GEMA Indemnities for any damages or loss to the extent that such damages or loss is caused by (a) any gross negligent actions or wilful misconduct of any GEMA Indemnities or (b) any violation of law or
regulation by any GEMA Indemnities. 

  

	17.2	GEMA agrees to defend, indemnify, and hold harmless Serendex and its respective employees, officers, directors (collectively “Serendex Indemnities”) against and from any damages or losses resulting from third
party claims, proceedings or investigations caused by (a) any negligent actions or wilful misconduct of GEMA or its Affiliates or (b) any violation of law or regulation by GEMA or its Affiliates, provided that GEMA shall have no obligation
to indemnify any Serendex Indemnities for any damages or loss to the extent that such damages or loss is caused by (a) any gross negligent actions or wilful misconduct of any Serendex Indemnities or (b) any violation of law or regulation
by any Serendex Indemnities. 

  

	17.3	For the avoidance of doubt neither Party shall be liable for any indirect or consequential loss or damages suffered by the other Party or its Affiliates. 

  
 -10- 

 [***] Indicates that information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

	18.	TERM AND TERMINATION 

  

	18.1	This Agreement shall be effective as of the Effective Date and continue in force until [***] from the Effective Date, whichever is longer. 

 

	18.2	6 months before termination of the initial period set out in Article 18.1 the Parties agree in good faith to negotiate a potential continuation of this Agreement. 

 

	18.3	Upon a material breach of this Agreement by a Party, the non-breaching Party shall provide a written notice to the Party in breach describing the material breach and stating its
intention to terminate this Agreement if the material breach is not remedied within fourteen (14) days after receipt of such notice. If the breaching Party does not remedy the breach within forty five (45) days after receipt of the notice,
the non-breaching Party is entitled to terminate this Agreement with immediate effect and without further notice. 

  

	18.4	Five (5) years after the effective Date GEMA can, at its sole discretion, with a 18 months prior written notice to Serendex terminate its obligation to produce and deliver
GM-CSF (cGMP Standard) to Serendex (for the avoidance of doubt the obligation to produce and deliver according to cGMP standard can in no event end prior to 6 1/2 years after the Effective Date). In this event
Serendex can without extra cost other than those set out in Article 3.3 take possession of - and use for cGMP production - the Back-up Master Cell Bank stored according to Appendix 7. GEMA shall assist
Serendex in setting up the production after the guidelines set up by Serendex. 

  

	19.	MISCELLANEOUS 

  

	19.1	Each Party shall do all such acts and execute all such documents as may be necessary in order to give effect to the provisions of this Agreement. 

 

	19.2	A party is not liable for a failure to perform any of his obligations if he proves that the failure was due to an impediment beyond his control and that he could not reasonably be expected to have taken the impediment
into account at the time of the conclusion of the agreement or to have avoided or overcome it or its consequences. 

  

	19.3	If the party’s failure is due to the failure by a third person whom he has engaged to perform the whole or a part of the contract, that party is exempt from liability only if: 

 

	 	a.	the is exempt under the preceding paragraph; and 

  

	 	b.	the person whom he has so engaged would be so exempt if the provisions of that paragraph were applied to him. 

  

	 	c.	the exemption provided by this paragraph has effect for the period during which the impediment exists. 

  

	 	d.	the party who fails to perform must give notice to the other party of the impediment and its effect on his ability to perform. If the notice is not received by the other party within a reasonable time after the party
who fails to perform knew or ought to have known of the impediment, he is liable for damages resulting from such non-receipt. 

 

	 	e.	nothing in this article prevents either party from exercising any right other than to claim damages under this Agreement. 

  
 -11- 

 [***] Indicates that information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

	19.4	Neither Party is entitled to assign any or all of its rights and transfer any or all of its obligations hereunder without the prior written consent of the other Party. 

 

	19.5	This Agreement shall be governed by and interpreted in accordance with Spanish Law, as practiced in the Kingdom of Spain, exclusive of choice of law provisions. 

 

	19.6	Any dispute arising out of or in connection with this Agreement, including any question regarding its existence, validity or termination, shall be referred to international arbitration and finally resolved by Madrid
Arbitration in accordance with the rules of arbitration procedures adopted by International Chamber of Commerce Arbitration and in force at the time when such proceedings are commenced. The rules of arbitration are deemed to be incorporated by
reference in this Clause. The arbitration tribunal shall consist of three (3) arbitrators. Each Party shall appoint one (1) arbitrator and the Chairman of Madrid Arbitration shall appoint a third arbitrator who shall be the chairman of the
arbitration tribunal. If within twenty-one (21) days after the receipt of a Party’s notification of the appointment of an arbitrator, the other Party has not notified the first Party of the
arbitrator he has appointed, the first Party may request the Chairman of London Arbitration to appoint the arbitrator. The language of the arbitration shall be English. 

This arbitration clause does not prevent the Parties to seek intermediate relief according to relevant national law. 

 

	19.7	In case any one or more of the provisions of this Agreement shall be determined to be invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions hereof shall
not in any way be affected or impaired thereby. 

  

	19.8	This Agreement contains the entire agreement between the Parties concerning the subject matter hereof and supersedes all prior representations, arrangements and understandings, oral or written, with respect to such
subject matter, including the CDA executed on 12 December 2007. Any amendment to this Agreement must be in writing and signed by an authorized representative of each Party. 

 

	19.9	The Parties are acting as independent contractors and shall not be deemed to be partners, joint ventures or each other’s agent or otherwise related. The Parties shall have no right to act on behalf of the other,
except as expressly set forth in this Agreement. 

  
 -12- 

 [***] Indicates that information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

	19.10	All notices required or provided for use in this Agreement shall be in English and in writing and shall be given by registered mail, courier and properly addressed to the address of the Party to be served as shown
below: 

 GEMA Biotech 

San Vladimiro 30256, 1st. Floor 

B1642GMB San Isidro, Buenos Aires, 

Argentina 
 Att.: The CEO 

 
  

Serendex ApS 
 Slotsmarken 12, 1
th 
 2970 Hoersholm 
 Denmark

 Att.: The CEO 
 This Agreement will be
executed in 2 (two) counterparts, each of which will be deemed an original, but all of which together will constitute one and the same instrument. Facsimile signatures are acceptable to be followed by original signatures. 

 

					
			
	Date:	 		 	Date:
			
	For GEMA Biotech:	 		 	For Serendex Aps:
			
	 /s/ Carlos Dupetit
	 		 	 /s/ Lasse Lindblad

	CEO	 		 	CEO
			
		 		 	 Lars Heslet

		 		 	Chairman

  
 -13- 

 [***] Indicates that information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

 APPENDICES 
  

			
	Appendix 1	 	API Formulation
	Appendix 2	 	API Specifications
	Appendix 3	 	Finished Product
	Appendix 4	 	GEMA Know-How
	Appendix 5	 	Description of Master Cell Bank
	Appendix 6	 	Description of Working Cell Bank
	Appendix 7	 	Back-up Master Cell Bank
	Appendix 8	 	Terms for Transfer and Release
	Appendix 9	 	Forecast
	Appendix 10	 	Quality Agreement
	Appendix 11	 	Serendex IP
	Appendix 12	 	Price per vial of 1 Gram

  
 -14- 

 [***] Indicates that information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

 Appendix 1 

API Formulation 
 “Active
Pharmaceutical Ingredient” or “API” shall mean Amega recombinant human Granulocyte-Macrodphage Colony-Stimulating Factor (rhGM-CSF) obtained from [***] meeting all the API Specifications mutual agreed by the parties. The
amino acid sequence of rhGM-CSF is identical to the natural molecule but it is non-glycosylated. The molecular weight is 14.5 kD, and the API is formulated as a concentrated solution. 

Serendex shall be offered as right of first refusal any new formulations and/or modifications of API on terms comparable to the terms of the Supply and
License Agreement, including but not limited to e.g. pegylated forms of rhGM-CSF. 

  
 Appendix 1, Page 1 of 1

 [***] Indicates that information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

 Appendix 2 

API Specifications 
  

			
	Description:	  	Human Recombinant Molgramostin (rhGM-CSF) Concentrated Solution
		
	Exipients:	  	[***]
		
	Storage:	  	Below -20°C, protected from light

 [***] 

  
 Appendix 2, Page 1 of 1

 [***] Indicates that information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

 Appendix 3 

Finished Product 
 “Finished
Product” (FP) shall mean any pharmaceutical formulation of the API in a defined embodiment (vial, syringe or other devises including stoppers, liners and caps as applied) produced by Amega. 

The amino acid sequence of rhGM-CSF is identical to the natural molecule but it is non-glycosylated. The molecular weight is 14.5 kD. The API is formulated in
a concentration of 300 μg/ml. 

  
 Appendix 3, Page 1 of 1

 [***] Indicates that information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

 Appendix 4 

Amega Know-How 

“Amega Know-How” shall mean any and all know-how directly
relating to the specific manufacture of the API and Finished Product, including the Master Cell Bank and the Working Cell Bank. 

  
 Appendix 4, Page 1 of 1

 [***] Indicates that information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

 Appendix 5 

Master Cell Bank 
 “Master Cell
Bank” shall mean the cell bank from which the Working Cell Bank has been derived, manufactured and characterized and stored as described in ICH guideline Q5B. 

  
 Appendix 5, Page 1 of 1

 [***] Indicates that information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

 Appendix 6 

Working Cell Bank 
 “Working Cell
Bank” shall mean the cell bank from which the API is manufactured. 

  
 Appendix 6, Page 1 of 1

 [***] Indicates that information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

 Appendix 7 

Back-up Master Cell Bank 

“Back-up Master Cell Bank” shall be a copy of the defined Master Cell Bank, and shall be deposited at
CMC Biologics in Herlev, Denmark (www.cmcbio.com). 
 The Back-up Master Cell Bank shall be stored as described in
ICH guidline Q5B. 
 The cell lines in the Back-up Master Cell Bank shall ensure that Serendex is able to set up its
own production and produce cGMP GM-CSF if forced to do so according to Article 3 of the Supply and License Agreement. 

  
 Appendix 7, Page 1 of 1

 [***] Indicates that information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

 Appendix 9 

Forecast 
 Serendex order
forecast in GRAMS 
  

					
	2012	 	[***]	 	Confirmed
			
	2013	 	[***]	 	Confirmed
			
	2014	 	[***]	 	Preliminary
			
	2015	 	[***]	 	Preliminary
			
	2016	 	[***]	 	Preliminary

  
 Appendix 9, Page 1 of 1

 [***] Indicates that information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

 Appendix 11 

Serendex IP 
 Strategy 

Serendex is pursuing an aggressive intellectual property (IP) protection strategy. This encompasses claims-to-use patents as well as claims on methods of treating diseases, pharmaceutical formulations, and methods to manufacture. 

GM-CSF (PCT/PCT/DK2007/050161) 

The invention provides a method for enhancing pulmonary host defense in a subject suffering from, for example, but not limited to, lung cancer, pneumonia,
pneumocystis carinii or cystic fibrosis with bacterial, fungal and/or viral infection and/or bacterial, fungal and/or viral colonization by administering to the subject an effective amount of granulocyte-macrophage colony stimulating factor (GM-CSF) via pulmonary administration. 

  
 Appendix 11, Page 1 of 1

 [***] Indicates that information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

 Appendix 12 

Price per vial of 1 gram 
 Price per vial
of 1 gram API is agreed to be [***]. 

  
 Appendix 12, Page 1 of 1

 [***] Indicates that information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

 

 
 Addendum to Supply and License Agreement, 22 February 2016 

 
 GEMA Biotech S.A. 

and 
 Serendex Pharmaceuticals A/S 

  

 [***] Indicates that information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

							
	Contents	  			
			
	 1
	 	 Definitions
	  	 	3	  
	 2
	 	 Background and purpose
	  	 	4	  
	 3
	 	 License of the Agreement
	  	 	5	  
	 4
	 	 Technical Transfer
	  	 	6	  
	 5
	 	 Technical Services
	  	 	6	  
	 6
	 	 Price and Costs of the Tech Transfer
	  	 	7	  
	 7
	 	 Intellectual Property Rights
	  	 	8	  
	 8
	 	 Selling of the master cell bank and working cell bank
	  	 	8	  
	 9
	 	 Royalties
	  	 	9	  
	 10
	 	 Appointment of CMO
	  	 	10	  
	 11
	 	 Confidential Information
	  	 	10	  
	 12
	 	 GEMA warranties
	  	 	11	  
	 13
	 	 Liability and indemnification
	  	 	11	  
	 14
	 	 Force Majeure
	  	 	12	  
	 15
	 	 Term and Termination
	  	 	13	  
	 16
	 	 Assignment and Change of Control
	  	 	13	  
	 17
	 	 Precedence
	  	 	14	  
	 18
	 	 Severability
	  	 	14	  
	 19
	 	 Governing Law and Venue
	  	 	14	  

 Appendices 
  

			
	Appendix 1:	  	Introduction and scope
	Appendix 2:	  	Transfer Plan
	Appendix 3:	  	List of Technology Assets
	Appendix 4:	  	Technical Information
	Appendix 5:	  	Requirements for training of CMO personnel
	Appendix 6:	  	API Specifications

  
 2 

 [***] Indicates that information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

 Between 
 GEMA
Biotech S.A. 
 Av. Sargento Cayetano Beliera 3025 
 Edificio
Insignia M1 
 Pilar-Province of Buenos Aires 
 Argentina 

(“GEMA”) 
 and 

Serendex Pharmaceuticals A/S 
 CVR 3053 2228 

Slotsmarken 17, 2. 
 2970 Horsholm 

Denmark 
 (“Serendex”) 

(Individually referred to as a “Party” and collectively as the “Parties”) 

this Addendum to the Supply and License Agreement (the “Agreement”) has on 22 February 2016 been entered into concerning GEMA’s grant of
license to Serendex to have API manufactured by a third party CMO. 
  

	1	Definitions 

  

	1.1	Unless explicitly stated otherwise, the terms and definitions used in this Addendum shall have the same meaning as set out in the Agreement. 

 

	1.2	“API Technology” shall mean any and all rights, technology and know-how related to the API including but not limited to the Technical Information, Technical Service,
Technology Assets, GEMA Know-How, know-how, patents, technical knowledge and any other rights or information, encompassing the manufacture, testing, quality control and
other API related know-how. 

  

	1.3	“License” shall mean the license granted by GEMA to Serendex pursuant to this Addendum. 

  

	1.4	“Transfer Plan” shall mean the complete Transfer plan attached in Appendix 2 for the Transfer including description of processes, analyses, responsibilities, deadlines etc. 

  
 3 

 [***] Indicates that information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

	1.5	“Successful Transfer” shall mean the first production by the CMO of a full size API batch in accordance with the API Specifications. 

 

	1.6	“Technical Information” shall mean all technical documents related to the API Technology and API Specification as used by GEMA in the manufacture of the API on its own production facilities and necessary and
sufficient for the manufacture of API by the CMO. 

  

	1.7	“Technical Service” is the necessary technical service concerning technical training, provided by GEMA to the CMO and Serendex for the manufacture of API by the CMO. 

 

	1.8	“Technology Assets” shall mean the assets described in Appendix 3. 

  

	1.9	“Territory” shall mean the entire world. 

  

	1.10	“First Full Scale Engineering Batch” shall mean a full scale fermentation batch that leads to a batch of purified Product (API), meeting specifications. 

 

	2	Background and purpose 

  

	2.1	In December 2012, the Parties entered into the Agreement concerning Serendex supply and License of API Know How and Technology by GEMA in order to allow Serendex to conduct research, develop, distribute, commercialize
and market of Final Products based upon the API. 

  

	2.2	The Parties have now agreed to transfer the manufacture of the API from GEMA to a CMO. This Addendum set forth the terms and condition under which GEMA grants a license to Serendex to utilise the API Technology and API
Specifications and to have a CMO manufacture API for Serendex. Furthermore, Serendex is determined to purchase and acquire from GEMA the complete ownership of the MCB and the WCB. 

  
 4 

 [***] Indicates that information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

	3	License of the Agreement 

  

	3.1	Scope of the License 

  

	 	3.1.1	GEMA accepts that the CMO appointed in accordance with this Addendum is entitled to use the API Technology and API Specifications in order to manufacture API for Serendex. 

 

	 	3.1.2	GEMA shall transfer the Technology Assets listed in Appendix 3 to the CMO and any other API Technology required in order to enable the CMO to manufacture API for Serendex. 

 

	 	3.1.3	GEMA shall provide sufficient information in order to enable the CMO to produce the API in accordance with the API Specifications and in accordance with the Quality Agreement. 

 

	 	3.1.4	Any API Technology, including but not limited to the Technology Assets, transferred to the CMO, shall remain the ownership of GEMA until the total purchase price for acquiring the MCB and WCB form GEMA, has been
executed by Serendex. 

  

	 	3.1.5	The CMO is solely entitled to use the API Technology and API Specifications in accordance with the License and for the purpose of manufacture API (i) to be supplied to Serendex or (ii) to be used in the
production of Finished Products for Serendex. 

  

	 	3.1.6	The terms and conditions of the CMO’s manufacture and supply of API and/or Finished Products to Serendex is regulated by separate agreement between Serendex and the CMO. 

  
 5 

 [***] Indicates that information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

	3.2	Extent of the License 

  

	 	3.2.1	The right to use the API Technology and API Specification shall be on an exclusive basis within the Field and within the Territory as set forth in the Agreement. GEMA shall not appoint any other manufacturer or licensee
for manufacturing of API. However, for the avoidance of doubts, GEMA shall have the right to continue produce API on its own for commercial purpose. 

  

	 	3.2.2	Except as otherwise provided for under this Addendum, the CMO shall have no rights in or to the API Technology and shall not sub-licence, in part or as a whole, any rights granted under this Addendum. 

 

	4	Technical Transfer 

  

	4.1	Pursuant to this Agreement, GEMA shall provide Technical Information to the CMO and Serendex which will be complete and reliable, correct and shall contain the entire process for the manufacture of the API.

  

	4.2	The details of Technical Information that shall be provided by GEMA to the CMO are set out in Appendix 4. 

  

	4.3	For the purposes of clause 4.1, “complete” means that the Technical Information provided by GEMA shall be the same technical documentation used and possessed by GEMA in producing the same API.

  

	4.4	After receiving the Technical Information dispatched by GEMA, the CMO shall verify the documents as soon as possible from the receipt thereof. In case of any inconsistency with requirements stipulated in Appendix 4.

  

	5	Technical Services 

  

	5.1	The following Technical Service shall be provided by and performed by in connection with the Technical Transfer: 

  

	 	5.1.1	GEMA shall actively participate in the Transfer and shall provide the CMO with all necessary technical information and support in accordance with the Transfer Plan in Appendix 2 ensuring that the CMO is
successful in setting up the API production. 

  
 6 

 [***] Indicates that information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

	 	5.1.2	GEMA shall advise CMO and Serendex in designing a reasonable and correct process layout for the manufacture of the API. GEMA shall assist CMO in accomplishing the whole qualification and testing work in order for CMO
the set up the API production. 

  

	 	5.1.3	GEMA shall be responsible for providing reasonable technical training to the CMO personnel required for use of the API Technology. 

  

	 	5.1.4	In order to implement the API Technology with the CMO, GEMA agrees to dispatch experienced and qualified technical personnel to CMO premises. The scope and requirements for training of CMO’s personnel by GEMA are
stipulated in Appendix 5. 

  

	5.2	GEMA is obligated to provide the services described in this section 5 until the Successful Transfer has taken place. 

  

	5.3	GEMA’s obligation under the Agreement to supply API to Serendex shall continue until the Successful Transfer has taken place and Serendex is able to deliver Finished Products in compliance with Serendex’
existing delivery obligations towards its customers. 

  

	6	Price and Costs of the Tech Transfer 

  

	6.1	The total price of the Transfer i.e. the tech transfer and validation program at CMO is [***]. Costs related to the Tech Transfer will be borne by Serendex. 

 

	6.2	The Price for the Tech Transfer set forth in Art. 6.1. above shall be paid by Serendex to GEMA [***] at the time of signature of this Amendment; [***] one year after its signature, and [***] at the end of the validation
process. Notwithstanding the above mentioned price, Serendex shall pay to Gema an amount of [***], as per invoice, per month for a maximum of 6 months for the support and assistance of Gema to Serendex for the fulfilment of the Tec Transfer.

  
 7 

 [***] Indicates that information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

	6.3	Serendex shall reimburse GEMA’s all documented costs in assisting with the Transfer. These costs include cost of travels, documentation, translations of documentation, fees, equipment and technical training.

  

	6.4	Prior to defraying any expenses under clause 6.3, GEMA shall provide Serendex with an overview of activities performed and expected associated expenses. The overview must be approved by Serendex in writing in advance in
order for GEMA to be reimbursed. GEMA’s approval shall not be unreasonable withheld. 

  

	7	Intellectual Property Rights 

  

	7.1	API Technology and API Specification 

  

	 	7.1.1	All ownership and title to the API Technology and API Specification licensed under the License shall, until Serendex’ exercise the effective purchase of the MCB and WCB, remain the property of GEMA.

  

	7.2	Improvements 

  

	 	7.2.1	Any improvements which relate to the License, whether developed by CMO or Serendex, including but not limited to knowledge, technical information, technical documents, processes etc., shall be the exclusive property of
Serendex. 

  

	8.	Selling of the master cell bank and working cell bank 

  

	8.1	 Serendex will purchase and acquire the complete ownership in and to the MCB and WCB. GEMA agrees and confirms
that once the purchase transaction becomes effective, any and all ownership rights, title and interest in and to API Technology and API Specification are irrevocably and completely assigned and transferred by GEMA to Serendex on an exclusive, basis
within the Field and within the Territory, and that Serendex thus becomes the exclusive proprietor of the API Technology and API Specification and is entitled - in whole or in part - to exploit the API Technology and API Specification in whatsoever
manner that Serendex sees fit within the field, to manufacture API and to have API manufactured by a third party, and to sell, assign, reassign, transfer, 

  
 8 

 [***] Indicates that information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

	 	
license, sublicense, make available, communicate, and/or otherwise dispose in any manner of Finished Products and medicinal products based upon the API Technology and API Specification in whole
or in part and whether in original or amended form. 

  

	8.2	The aforementioned purchase shall take place within the first 18 months from Effective Date of the Addendum to the Agreement or after successful manufacture of the first Full Scale Engineering batch, whichever occurs
first. Serendex shall pay to GEMA for the ownership of the MCB and WCB the purchase price of 1,950,000 USD in cash. 

  

	8.3	If for any reason Serendex after the period set out in clause 8.2 does not execute the purchase of the MCB and WCB, it will be automatically considered as a default on this obligation and will carry a monthly
interest of 1% over the unpaid balance, and GEMA shall have the right to immediately start legal actions and seek for any remedy that might be applied in order to force SERENDEX to comply with the full payment plus the penalty hereby established.

  

	9	Royalties 

  

	9.1	Section 9 of the Agreement on pricing and royalty shall continue to apply as long as Serendex has not exercised the purchase. 

  

	9.2	When Serendex has purchased the WCB and the MCB, clauses 9.2.1 and 9.2.2 below apply instead of section 9 of the Agreement. 

  

	 	9.2.1	GEMA shall be entitled to receive a royalty covering Finished Products for commercial sales and use in approved medicinal products, which is established below from its annual Net Sales. The Parties have agreed
that there shall be no minimum royalty, no signing fee or milestones included in the royalty payments: 

  

					
	 Net Sales USD
	  	Royalty of Net Sales	 
	 <100 million
	  	 	[***	] 
	 100 million - 250 million
	  	 	[***	] 
	 250 million - 500 million
	  	 	[***	] 
	 500 million
	  	 	[***	] 

  

	 	9.2.2	Within 60 days after the expiry of a calendar year, Serendex shall report the Net Sales of the previous year and pay the royalties on Net Sales as set out in clause 9.2.1. 

  
 9 

 [***] Indicates that information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

	10	Appointment of CMO 

  

	10.1	Serendex shall appoint a CMO to manufacture the API. 

  

	10.2	Serendex shall inform GEMA in writing about the identity of the appointed CMO. 

  

	10.3	GEMA shall within 30 days after receiving the information on the CMO from Serendex, approve the appointed CMO by written notice to Serendex. Such approval shall not be unreasonably withheld. 

 

	11	Confidential Information 

  

	11.1	The Parties must keep confidential any and all Confidential Information which a Party or its directors, employees, representatives or advisers have received or will receive from the other Party in connection with
performance of this Addendum. 

  

	11.2	The Parties are each obliged to take precautionary measures that may be necessary with the aim of protecting Confidential Information against any unauthorized access, use, copying and/or disclosure and at least in
accordance with regulatory requirements. 

  

	11.3	The Parties shall ensure that employees, sub-suppliers or advisers are subject to an equivalent confidentiality obligation and to obtain a written confidentiality agreement from
the party in question. 

  

	11.4	A Party shall if possible immediately prevent and notify the other Party in case of any unauthorized access, use, copying and/or disclosure of Confidential Information which a Party is made aware of. 

 

	11.5	Confidential Information does not include information: 

  

	 	i)	which has been developed or obtained independently by the receiving Party prior to disclosure by the other Party; 

  
 10 

 [***] Indicates that information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

	 	ii)	which has been received in good faith from an independent third party; 

  

	 	iii)	which through a bona fide and independent third party becomes publicly available. 

  

	11.6	The Parties may give access to Confidential Information when this is required or necessary and provided the Party in question ensures that the information is treated as confidential by the recipient with respect to:

  

	 	i)	the Parties’ affiliated companies; 

  

	 	ii)	the Parties’ employees, sub-suppliers or advisers; 

  

	 	iii)	an ordinary due diligence process in relation to a Party; 

  

	 	iv)	in compliance with statutory law, court decision, testimony, access to documents or a final decision by a public authority, provided that the Party (if possible by law) notifies the other Party of this obligation and by
request allows the other Party to object against this obligation. 

  

	11.7	The Parties’ confidentiality obligations must remain in force five years following the termination of this Addendum. 

  

	12	GEMA warranties 

  

	12.1	GEMA represents and warrants that it has legal right and title in and to the API Technology and API Specification. 

  

	12.2	GEMA warrants that the API Technology and API Specification do not infringe the intellectual property rights of any third party, and no third party has claimed that GEMA infringes the intellectual property rights of
such third party and that no third party is infringing the API Technology and API Specification. 

  

	13	Liability and indemnification 

  

	13.1	 Serendex agrees to defend, indemnify, and hold harmless GEMA and its respective employees, officers, directors
(collectively “GEMA Indemnities”) against and from any 

  
 11 

 [***] Indicates that information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

	 	
damages or losses resulting from third party claims, proceedings or investigations caused by (a) any negligent actions or wilful misconduct of Serendex or its Affiliates or (b) any
violation of law or regulation by Serendex or its Affiliates, provided that Serendex shall have no obligation to indemnify any GEMA Indemnities for any damages or loss to the extent that such damages or loss is caused by (a) any gross negligent
actions or wilful misconduct of any GEMA Indemnities or by any violation of law or regulation by any GEMA Indemnities. 

  

	13.2	GEMA agrees to defend, indemnify, and hold harmless GEMA and its respective employees, officers, directors (collectively “Serendex Indemnities”) against and from any damages or losses resulting from third
party claims, proceedings or investigations caused by (a) any negligent actions or wilful misconduct of GEMA or its Affiliates or (b) any violation of law or regulation by GEMA or its Affiliates, provided that GEMA shall have no obligation
to indemnify any Serendex Indemnities for any damages or loss to the extent that such damages or loss is caused by (a) any gross negligent actions or wilful misconduct of any Serendex Indemnities or (b) any violation of law or regulation
by any Serendex indemnities. 

  

	13.3	For the avoidance of doubt neither Party shall be liable for any indirect or consequential loss or damages suffered by the other Party or its Affiliates. 

 

	14	Force Majeure 

  

	14.1	Neither Party is liable towards the other Party in the case of Force Majeure by way of any unforeseeable or accidental event or other circumstances which prevents a Party from fulfilling its obligations and which are
beyond that Party’s reasonable control and which the Party should not have foreseen or prevented, including but not limited to regulations by any government authority, war, riots, insurrection, toll inspections, embargo, explosions, epidemics,
civil disobedience, civil disorders, rebellions, revolutions, sabotage, terrorism, floods, storms, nuclear leakage or explosions, traffic accidents, fire, natural disasters, earthquake, or extreme weather, strike, lockout, boycott, blockade, key
person sickness, failure in telecommunication, network connections, power outage or other general infrastructure breakdown or failure. 

  

	14.2	If a deadline concerning one of the Parties is postponed due to Force Majeure, the other Party’s obligations that are connected thereto are postponed accordingly. 

 

	14.3	Force Majeure may only be relied upon if the Party in question has notified the other Party no later than 10 days following the time of Force Majeure. 

  
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Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

	14.4	The Party which is not affected by Force Majeure is entitled to terminate this Agreement wholly or partially if the Force Majeure event lasts more than 30 days. Partial termination is only possible to the extent that a
termination does not materially shift the commercial balance of this Agreement between the Parties and provided that the remaining provisions can stand alone. 

  

	14.5	Neither Party is obliged to pay compensation, damages or penalty to the other Party in case of Force Majeure and/or subsequent termination. 

 

	15	Term and Termination 

  

	15.1	This Addendum will enter into force on 22 February 2016 and unless Serendex exercises the purchase will be valid for the duration of the Agreement. 

 

	15.2	Upon a material breach of this Addendum by a Party, the non-breaching Party shall provide a written notice to the Party in breach describing the material breach and stating its
intention to terminate this Agreement if the material breach is not remedied within sixty (60) days after receipt of such notice. If the breaching Party does not remedy the breach within sixty (60) days after receipt of the notice, the non-breaching Party is entitled to terminate this Agreement with immediate effect and without further notice. 

  

	16	Assignment and Change of Control 

  

	16.1	Neither Party is entitled to assign this Addendum, or parts thereof or any rights without the other Party’s prior written consent. Notwithstanding the foregoing each Party is entitled to assign this Addendum
(i) to its’ Affiliated companies and (ii) to entities that purchases all or a substantial amount of that Party’s assets and liabilities or (iii) to subsequent owners due to a restructuring, merger, demerger or takeover of
the Party provided the assignment does not have a negative impact on the fulfilment of this Addendum and provided that the new third party owner enters into this Addendum. 

 

	16.2	If a Party assigns this Addendum in accordance with this Addendum the assignee undertakes in writing the assignor’s rights and obligations in accordance with this Addendum. 

  
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Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

	17	Precedence 

  

	17.1	In case of conflict or discrepancy between this Addendum and the Agreement or any schedules to Addendum or to the Agreement, this Addendum shall prevail over the schedules, documents and agreements referred to in this
Addendum unless the Parties explicitly agrees otherwise or this follows from the nature of the case. 

  

	17.2	To the extent not covered or amended by this Addendum, the terms of the Agreement and its appendices shall remain in force unless the Parties have clearly agreed otherwise by entering into this Addendum or this follows
from the nature of the case. 

  

	18	Severability 

  

	18.1	The invalidity or unenforceability of any provisions of this Addendum does not affect the validity or enforceability of any other provision of this Addendum, which will remain in full force and effect, provided such
this does not significantly shift the commercial balance between the Parties. The Parties are obligated to immediately initiate negotiations in a loyal manner with the purpose of replacing invalid or unenforceable provisions in order to draw up this
Addendum as originally intended. 

  

	19	Governing Law and Venue 

  

	19.1	Clauses 19.5 and 19.6 of the Agreement on governing law and venue, shall apply equally to this Addendum. 

 This
Addendum will be executed in two (2) counterparts, each of which will be deemed an original; but all of which together will constitute one and the same instrument. 

Facsimile signatures are acceptable to be followed by original signatures. 
  

									
	Date:	 	21ST March 2016	 		 	Date:	 	22 February 2016
	Name:	 		 		 	Name:	 	
	Title:	 		 		 	Title:	 	
			
	 /s/ Roberto Rodriguez /s/ Carlos Dupetit
	 		 	 /s/ Kim Arvid Nielsen

	Signature	 		 	Signature

  
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Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

 Appendix 1 : Introduction and Scope 

Introduction: 
 GEMABIOTECH has developed a
manufacturing process for recombinant GM-CSF based on [***]. The manufacturing process is defined as [***]. This process is described in more details in (Synthetic route) including a process flow
diagram, more detailed description of each of the process unit operations and a specification of the product (API). 
 Serendex Pharmaceuticals A/S has
entered into a supply agreement with GEMABIOTECH and have received API produced following the process descriptions in (Synthetic route) for further formulation Fill & Finish of Serendex’s IMP in Europe. 

GEMABIOTECH and Serendex has agreed to negotiate a technology transfer package that will enable manufacturing of the Molgramostim API at a European based CMO

 The Scope 
 The scope of this program is to make a
technology transfer program in accordance with the ICH guidelines Q6A, Q6B, Q7, Q8, Q9, 010 and Q11 with associated annexes. The process to be documented and transferred is shown in a process flow diagram . The manufacturing process is defined by
its unit operations that are characterized by operational parameters described in (Synthetic route). [***]. The technology transfer will be made on as close to a “one to one” transfer of the current [***] fermentation process with an
estimated yield of [***] of API to assure minimum risk for deviations to the set specifications which are reflected in the acceptance criteria from the following manufactured API batches in the Olivos manufacturing facilities: 13-GMCF-025-007,
13-GMCF-026-008 and
13-GMCF-028-009 

  
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Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

 Appendix2: Transfer Plan 

Transfer Plan 
  

					
	 Activity
	  	 Responsible
	  	 Timing

	 Send tech transfer documents for full scale process to Serendex
	  	GEMA	  	6 weeks after sign of addendum
	Approve API specifications	  	Serendex	  	15. Feb 2016
	Send tech transfer documents to CMO	  	Serendex	  	
	CMO input to comparability protocol and accept of transfer plan	  	Serendex	  	1 March 2016
	Regulatory evaluation of tech transfer plan	  	Serendex	  	1 March, 2016
	WCB established at CMO	  	Serendex	  	2 weeks after sign of addendum
	Transfer analytical methods (SOP/ validation) to Serendex/CMO. Release and in process controls	  	GEMA	  	2 weeks after sign of addendum
	Set up analytical methods at CMO	  	Serendex	  	Q1 - Q2 2016
	GEMA support to establishment of manufacturing process at CMO (small scale, up-scaling and full scale)	  	GEMA	  	Ongoing
	Manufacturing of small scale ref material [***] at CMO	  	Serendex	  	TBD
	Up-scaling manufacturing process [***] at CMO	  	Serendex	  	TBD after sign of addendum
	Manufacturing of full scale engineering [***] batch - released & reference standard.	  	Serendex	  	[***]
	Manufacturing of first full scale GMP batch and released	  	Serendex	  	[***]

 Responsibility Matrix for tech transfer of a manufacturing process from GEMABIOTECH to CMO 

 

							
	 Responsibilities
	  	 GEMA
	  	 Serendex
	  	 
	 Establish governance structure
	  	x	  	x	  	
	 Tech transfer team members
	  	x	  	x	  	
	 Head of tech transfer team
	  		  	x	  	
	 Provide adequate and skilled personnel for tech transfer activities
	  	x	  		  	
	Define load of work associated with GEMA compilation of documentation and other defined tech transfer activities	  	x	  		  	
	 Approve and sponsor the additional GEMA tech transfer activities
	  		  	x	  	
	 Provide adequate support to Serendex regulatory submissions
	  	x	  		  	

  
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Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

							
	 Tech transfer documentation
	  		  		  	
	 Update DMF
	  	x	  		  	

  

							
	Documentation for Master and Working cell banks (Development reports)	  	x	  		  	
	Deposit agreed amounts of vials of MCB and WCB in EU	  	x	  		  	
	Deposit - upon approval of addendum- mock cell line for Host Cell Protein assay development	  		  		  	
	Provide and maintain inventory of cell banks	  	x	  		  	
	Preparation of list of equipment	  	x	  		  	
	Preparation of bill of raw materials with vendors specifications	  	x	  		  	
	Present available process data from small scale development batches to CMO to support scale down to [***]	  	x	  		  	
	Tech transfer document : Upstream and down- stream process description detailed for transfer including operating parameters	  	x	  		  	
	Provide Executed Batch Process Records for 13-GMCF-025-007, 13-GMCF-026-008; 13-GMCF-028-009. (pdf
format)	  	x	  		  	
				
	Approval of Tech Transfer Document.	  		  	x	  	
	Analytical (in process and release) SOP’s and validation protocols and reports	  	x	  		  	
	Preparation of DS specifications	  	x	  		  	
	Approval of DS specifications	  		  	x	  	
		  	x	  		  	
	Delivery- upon approval of addendum- one batch of Inclusion bodies to CMO for onset of process set up	  		  		  	
				
	Identification of GEMA “person in plant” supporting implementation at CMO	  	x	  		  	
	Sponsoring of person in plant	  		  	x	  	
	Cleaning Validation performed prior to API Fill. Evt the protocol for standard cleaning validation	  	x	  		  	

  
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Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

 Appendix3: List of Technology Assets 

 

	•	 	Cell banks. Master and Working Cell banks (GEMA) 

  

	•	 	Fermentation knowhow (GEMA) 

  

	•	 	Renaturation and purification knowhow (GEMA) 

  

	•	 	Tech Transfer Document (GEMA )) 

  

	•	 	Development Reports (GEMA). 

  

	•	 	Development data outside the scope of development reports 

  

	•	 	API specific analytical assets 

  

	•	 	GEMA validated methods (DNA, General HCP) 

  

	•	 	Serendex validated methods (RP-HPLC, Sec-HPLC, Potency, Specific HCP, structural analysis as CD, UV and
S-S bonds) 

  

	•	 	Other 

  
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Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

 Appendix4: Technical Information 

 

	•	 	Batch Records (for batches 13-GMCF-025-007; 13-GMCF-026-008; 13-GMCF-028-009) as well as
batch data from GEMA development batches 

  

	•	 	Certificates of Analysis for the above mentioned API batches 

  

	•	 	Description of the process to be transferred. Tech transfer document. 

 [***] 

  
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Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

 19.1.1.1 Synthetic route 

[*** (5 pages)] 

  
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Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

 Appendix 5: Requirements for training of CMO personnel 

 

	 	•	 	GEMA tech transfer person (team?) to link info into CMO with ref to Serendex 

  

	 	•	 	Person in plant from GEMA to CMO for practical set up. 

  
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Commission. Confidential treatment has been requested with respect to the omitted portions. 
  

 Appendix 6: API Specifications 

AA sequence of hGM-CSF 
  

					
	APARSPSPST	  	QPWEHVNAIQ	  	EARRLLNLSR
	DTAAEMNETV	  	EVISEMFDLQ	  	EPTCLQTRLE
	LYKQGLRGSL	  	TICLKGPLTMM	  	ASHYKQHCPP
	TPETSCATQI	  	ITFESFKENL	  	KDFLLVIPFD
	CWEPVQE	  		  	

 Table xx Specification for molgramostim concentrated solution 

[*** (2 pages)] 
  

	*	Not applicable for R&D batches. 

  
 22EX-10.62

 Exhibit 10.62 

[***] Indicates that information has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions. 
 EXECUTION COPY 

COMMERCIAL SUPPLY AGREEMENT 

This COMMERCIAL SUPPLY AGREEMENT (“Agreement”), dated as of 24 April 2015 (“Effective Date”), is
made between PARI Pharma GmbH, a German corporation, with a principal place of business at Moosstrasse 3, D-82319 Starnberg, Germany (“PARI”), and Serendex, Pharmaceuticals A/S,
Slotsmarken 17, 2.tv., DK-2970 Horsholm, Denmark (“Serendex”). PARI and Serendex are sometimes referred to herein individually as a “Party” and collectively as the
“Parties.” 
 RECITALS 

WHEREAS, PARI is in the business of developing, manufacturing and commercializing, among other things, drug inhalation devices and
optimized formulations used in the treatment of respiratory tract disorders. 
 WHEREAS, Serendex is in the business of developing
and commercializing drugs for various diseases and conditions, including without limitation the treatment of respiratory tract disorders and infectious diseases. 

WHEREAS, PARI and Serendex are parties to a certain research collaboration and license Agreement effective as of November 7, 2014
(the “License Agreement”). 
 WHEREAS, pursuant to Section 4.3 of the License Agreement, the Parties desire to
enter into this Agreement for PARI to manufacture and supply the Device (as defined below) and Device Accessories (as defined below) for commercial use with the Serendex Product (as defined below) after obtaining Marketing Approval for the Serendex
Product. 
 NOW, THEREFORE, in consideration of the premises and direct and indirect benefits to the Parties hereto and other
consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties hereby agree as follows: 
  

	1.	DEFINITIONS 

 Capitalized terms used but not defined in this Agreement shall have the
meanings ascribed to them in the License Agreement. In addition, the following terms shall have the meanings set forth below: 

1.1 “Applicable Laws and Standards” means (a) all laws, ordinances, rules, directives and
regulations applicable to the PARI Products or the Serendex Products, as applicable, including without limitation applicable local laws and regulations in each country in the Territory, (b) applicable regulations and guidelines of the FDA and
other Regulatory Authorities and the ICH guidelines; (c) as applicable to the particular activities performed, Good Manufacturing Practices, Good Laboratory Practices and Good Clinical Practices promulgated by the FDA and other Regulatory
Authorities or the ICH; and (d) all applicable industry and trade standards, including the applicable standards of the International Organization for Standardization (ISO). 

1.2 “Baseline Price” has the meaning set forth in Section 4.1(a). 

1.3 “Cure Period” means the fifteen (15) Business Day period following the date of issuance of a
Notice of Failure Event. 

  
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 1.4 “Device” means the eFlow® Technology device (including the following components: eBase Controller, Nebulizer Handset, nebulizer connection cord and power supply) that has been optimized for the Serendex Product as set
forth in more detail in Exhibit A. 
 1.5 “Device Accessories” means those
types of accessories sold by PARI as of the Effective Date or during the term of this Agreement for use with Devices, which are not specific to the drug substance being delivered by such Devices, including e.g. power adapters, carrying cases,
face masks, and any replacement parts associated with the foregoing. For clarity, the Parties agree that the Device Accessories will not include the control unit. 

1.6 “Device Specifications” means the characteristics, processing, labeling, and packaging requirements
and standards for the Device and Device Accessories, as set forth in Exhibit A and the Territory Specific Appendices. 

1.7 “Drug Reference” has the meaning set forth in Section 3.4(a). 

1.8 “eBase Starter Kit” has the meaning set forth in Section 4.1. 

1.9 “Failure Event” has the meaning set forth in Section 6.9(b). 

1.10 “Forecast” shall have the meaning set forth in Section 6.4. 

1.11 “Good Manufacturing Practices,” or “GMP” means all good manufacturing practices as promulgated
by the Regulatory Authority of the country where the Device is being sold, in the form of laws or regulations or guidance documents, for the manufacturing of pharmaceutical products, including in the United States as promulgated by the FDA 21 CFR
§§ 210 – 211, and medical devices, including 21 CFR § 820 – Quality System Regulation. 

1.12 “GMP Manufacturing” means all processes and activities typically engaged in by a person or entity
in the pharmaceutical or medical device industry for the GMP manufacture of a product or component thereof, including procuring raw materials, manufacturing, quality control and assurance testing, GMP record keeping, packaging and labeling. 

1.13 “Initial Purchase Order” shall have the meaning set forth in Section 6.5. 

1.14 “Limited Manufacturing Back-Up License to” shall have the
meaning set forth in Section 6.9(d). 
 1.15 “Nebulizer Handset” means the eFlow® Technology Nebulizer handset (including the following components: plastic parts of the nebulizer handset and one aerosol head) that has been optimized for the Serendex Product as set forth in
more detail in Exhibit A. 
 1.16 “Notice of Failure Events” shall have the
meaning set forth in Section 6.9(b). 
 1.17 “PARI Products” means, collectively, Device, eBase
Starter Kits, Nebulizer Handsets and Device Accessories. 
 1.18 “PARI Property” shall have the
meaning set forth in Section 6.9(d). 

  
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 1.19 “Prices” shall have the meaning set forth in
Section 4.1. 
 1.20 “Quality Agreement” shall have the meaning set forth in Section 6.2.

 1.21 “Recall” means a recall, withdrawal, or field correction of any product for any reason, or a
dissemination of information regarding such product due to a change in the labeling of such product. 
 1.22
“ROW” means all the countries in the Territory excluding the United States and Canada. 
 1.23
“Serendex Product” means the Drug Product formulated for delivery via pulmonary administration exclusively for use with the Device in the Serendex Field. 

1.24 “Term” shall have the meaning set forth in Section 12.1. 

1.25 “Territory” means the world. 

1.26 “Territory-Specific Appendix” means each sub-appendix
attached to this Agreement under Appendix A summarizing the applicable Device Specifications and the specific commercial terms for the manufacture and supply of PARI Products in one or more particular country(ies) in the Territory. From time
to time, the Parties, through the Joint Steering Committee, may agree to add the Territory-Specific Appendices, or modify additional Territory-Specific Appendices applicable to one or more particular country(ies) to this Agreement. Such
Territory-Specific Appendices may contain provisions, terms and conditions that are exceptions to or different from this Agreement to address country specific conditions, provided, both Parties have agreed thereto in writing. 

1.27 “Third Party” means any person or entity that is not PARI, Serendex or any Affiliate of either
PARI or Serendex. 
 1.28 “United States” means the United States of America and all of its
territories and possessions. 
  

	2.	GOVERNANCE; JOINT STEERING COMMITTEE 

 2.1 Joint Steering Committee
(“JSC”). 
 (a) Additional Responsibilities. The JSC as set forth in Section 3.7 of the
License Agreement shall have the following additional responsibilities: 
 (1) to communicate regarding
Serendex’s worldwide strategy for the commercialization of the Serendex Product; 
 (2) to communicate regarding
PARI’s worldwide strategy for the licensing and commercialization of the PARI Products and to coordinate such strategy with Serendex’s strategy set forth in subsection (a) above; 

(3) to facilitate the exchange of information between the Parties with respect to the activities hereunder; 

  
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 (4) to establish procedures for the efficient sharing of information
necessary for the supply of the PARI Product; 
 (5) to share, discuss and coordinate between the Parties to ensure
that the overall market demand of PARI Products for use with Serendex Product is met; 
 (6) to create subcommittees
as the JSC may find necessary or desirable from time to time for implementation of the research, development and commercialization hereunder; 

(7) to oversee the activities of subcommittees created under this Agreement, and to seek to resolve any issues that
such subcommittees cannot resolve; and 
 (8) to perform such other functions as appropriate to further the purposes
of this Agreement. 
 (b) Guiding Principles. The JSC shall perform its responsibilities based on the
principles of good faith, diligence, prudence and good scientific and business judgment. The JSC shall have only the powers assigned expressly to it under this Article 2 and elsewhere in this Agreement, and the JSC shall not have any power to amend,
modify or waive compliance under this Agreement. 
 (c) JSC Meetings. The JSC will be chaired by a
representative of Serendex. The role of the chairperson shall be to convene and preside at meetings of the JSC, but the chairperson shall have no additional powers or rights beyond those held by the other Committee representatives. Within ten
(10) Business Days following each JSC meeting, the chairperson shall prepare and deliver to the members of the JSC the minutes of such meeting for review and approval by both Parties. The minutes shall reflect, without limitation, all material
decisions made at such meetings. Such minutes will be deemed approved unless one or more members of the JSC object to the accuracy of such minutes within ten (10) Business Days of receipt thereof 

(d) No Decisions. Notwithstanding anything to the contrary in this Agreement, no decision by either Party would
be effective if such decision requires the other Party to breach any obligation or agreement with a Third Party, or to perform any activities that are different or greater in scope than those provided for specifically under this Agreement. 

2.2 Subcommittees. 

(a) Membership. The JSC may establish subcommittees to coordinate specific activities. Each such subcommittee
shall consist of two (2) representatives from each Party. Each Party may replace its appointed subcommittee representatives at any time upon reasonable written notice to the other Party. Each Party shall designate one (1) of its
representatives as the co-chairpersons of each subcommittee. 
 (b)
Responsibilities. The responsibilities of each subcommittee shall include: 
 (1) to serve as the ongoing
liaison between the Parties for the tasks that it is responsible for; 

  
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 (2) to coordinate efforts related to the supply of Device and Device
Accessories in the country (ies) in the Territory that it is responsible for; and 
 (3) to perform such other
functions as appropriate to further the purposes of this Agreement as directed by the JSC. 
 Such subcommittees shall not
have the right to amend, modify or waive compliance under this Agreement. 
 (c) Decision Making. Each
subcommittee shall make decisions unanimously, and each Party’s representatives shall collectively have one (1) vote. In the event any subcommittee cannot reach an agreement regarding a decision within its authority for a period of thirty
(30) days, it shall refer such matter to the JSC for resolution pursuant to Section 2.1(d). 
 (d)
Subcommittee Meetings. Other representatives of each Party may attend meetings as nonvoting observers (provided such nonvoting observers have confidentiality obligations to such Party that are at least as stringent as those set forth in this
Agreement). Meetings of the subcommittees shall be effective only if at least one (1) representative of each Party is present or participating. Each Party shall be responsible for all of its own expenses of participating in the subcommittee
meetings. Within ten (10) Business Days following each subcommittee meeting, Serendex shall prepare and deliver to the members of the subcommittee the minutes of such meeting for review and approval by both Parties. 

 

	3.	COMMERCIALIZATION 

 3.1 Overview. PARI shall be responsible
for, and shall have the sole discretion for the product support for PARI Products in the Territory (unless otherwise set forth in this Agreement) in compliance with all Applicable Laws and Standards, and for training the appropriate Serendex
commercial team members. Serendex shall not use or disseminate promotional and/or advertising materials for the Serendex Products containing PARI Products related sections without PARI’s prior written approval. However, no approval shall be
needed for use or dissemination of PARI Products related sections which were already approved with identical content and format by PARI before. Serendex shall be responsible for, and shall have the sole discretion for promoting, advertising,
supporting and distributing Serendex Products in compliance with all Applicable Laws and Standards, and for training and supporting its sales force and product support personnel in connection therewith. The Parties shall cooperate in good faith to
fulfill their respective obligations under this Agreement and to achieve the commercial potential of the Serendex Products within the regulatory guidelines established for sales of such products. 

3.2 Commercialization of PARI Products. PARI shall sell the PARI Products to Serendex or any Third Party
designated by Serendex as its representative to be further distributed to end users for use with the Serendex Product. 

3.3 Territory-Specific Appendices. Promptly after Serendex submits a MAA for a Serendex Product in
(a) particular country(ies), but in any event no later than one (1) year prior to the earliest anticipated approval date by the appropriate Regulatory Authority of such MAA, the Parties shall agree on a Territory-Specific Appendix setting
forth the terms governing such country(ies), which shall contain terms and conditions necessary to commence commercial sales of the PARI Products and Serendex Product in such country(ies). Such Territory-Specific Appendixes shall then be attached to
this Agreement and incorporated in this Agreement. Thereafter, the Parties may modify or supplement such Territory-Specific Appendixes from time to time by written agreement. 

  
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 3.4 Branding Generally. Subject to applicable Regulatory
Requirements, the pack-aging, labeling and promotional materials for both the PARI Products and the Serendex Products will be consistent with a branding strategy to be agreed upon by the Joint Steering Committee and included as part of each
Territory-Specific Appendix (the “T-S Branding Strategy(ies)”). At a minimum, such T-S Branding Strategies shall contain the following elements, unless
otherwise agreed to by the JSC or required by Regulatory Requirements: 
 (a) PARI Product Branding. PARI
shall be responsible for, and shall work together with Serendex in good faith in selecting trademarks for use on or in connection with any PARI Product that is aligned with PARI’s branding strategy for eFlow Technology products. PARI will label
the packaging for the Device and the packaging for the replacement nebulizer handset of the Device. As determined by PARI, packaging will include the PARI word-mark and/or logo and/or the PARI Pharma logo, the EFLOW® Technology trademark, a dedicated, unique brand name for the Device, and the Drug Reference (as defined below). The nebulizer handset component of the Device will include the dedicated, unique
brand name for the Device and the Drug Reference. The aerosol head component of the Device will include only the dedicated, unique brand name for the Device. Some of the above Device components may have a distinct item number, and, to the extent
applicable, all such item numbers will be identified on the packaging for the Device and the packaging for the replacement nebulizer handset. For purposes of this Section 3.4, unless specified otherwise by Regulatory Authorities, the
“Drug Reference” means either (i) the generic drug name associated with the Serendex Product, and/or (ii) Serendex’s trademark for such Serendex Product, depending upon the status of Serendex’s branding
for the Serendex Product at the time of commercialization by the Parties as contemplated herein. Notwithstanding the foregoing, the Parties shall discuss the precise forms of co-branding to accompany the PARI
Products and the Serendex Products, including support or other promotional materials therefor, to promote the use of the PARI Products exclusively for use with the Serendex Product. Serendex shall not modify PARI’s labeling in any way
(including by over-labeling), and all support and promotional materials including any of PARI’s trademarks, artwork, images or similar materials must be reviewed and approved by PARI pursuant to agreement by the appropriate subcommittee or
otherwise in writing prior to use. Serendex shall not use any photographs or graphic depictions of the PARI Products without PARI’s prior written approval. However, no approval shall be needed for labeling or for use of other materials which
were already approved with identical content and format by PARI before. 
 (b) Serendex Product Branding/PARI
Product Recognition. Serendex shall be responsible for, and shall have sole discretion, in selecting trademarks for the use on or in connection with any Serendex Product and determining the packaging, labeling and branding of any Serendex
Product; provided, however, that, where appropriate, Serendex shall provide recognition of the PARI Product approved by the applicable Regulatory Authority for use with the Serendex Product. In addition, subject to Regulatory Requirements, Serendex
agrees to include in the product labeling for the Serendex Product the precise Device brand name and the Device item number(s) approved to administer the Serendex Product. 

3.5 Product Support. Each Territory-Specific Appendix shall set forth the product support capabilities and
responsibilities in a certain country for PARI Products and for Serendex Products. 

  
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	4.	PAYMENTS 

 4.1 Pricing. 

PARI shall sell Devices, Nebulizer Handsets and eBase starter kits (comprised of an eBase controller and other Device Accessories, but
excluding the Nebulizer Handset (“eBase Starter Kit”)) for commercial use after Marketing Approval at the prices determined according to Subsections (a), (b) and (c) below (the “Prices”) to Serendex. 

(a) Baseline Price. PARI shall sell the PARI Products listed below at the initial prices as of the Effective
Date (the “Baseline Prices”) to Serendex: 
 Table 1. Baseline Prices 

 

			
	for each unit of Nebulizer Handset	  	[***]
	for each unit of eBase Starter Kits	  	[***]

  

	*	co-packaged or co-shipped with Serendex Product only (i.e. not for sale via PARI distributors). 

(b) Price Adjustment According to Index of Producer Prices. The Parties agree that the Baseline Prices set forth
above may be adjusted from time to time by at least ninety (90) days prior written notice to Serendex, provided that (i) such increase shall not occur more often than once every twelve (12) months and (ii) the percentage of such
increase shall not exceed the percentage of the increase of the German index of producer prices of industrial products (published by the German Federal Statistical Office on “www.destatis.de/EN/FactsFigures/Indicators/Short
TermIndicators/Prices/pre110.html”) from the (i) Effective Date in case of the first increase, or (ii) the date of the last increase in case of any subsequent increases. 

(c) Volume Discounts. The Prices for Devices, eBase Starter Kits and Nebulizer Handsets shall be subject to
volume discounts according to Table 2 and Table 3. The percentage price reductions shall be calculated based on the Baseline Prices set forth in Table 1 and the price adjustments according to Section 4.1(b). The price reduction shall be granted
in case that the volume of PARI Products in a twelve (12) months’ period exceeds the threshold as set forth in Table 2 and Table 3 below. The first twelve months’ period shall be the twelve months preceding the month in which the
first time the cumulative orders of such preceding months exceeded the respective threshold (the “Initial Discount Period”). After the Initial Discount Period all following twelve months’ periods shall commence on the first months
after the end of the Initial Discount Period. By way of example if Serendex purchased at least [***] Nebulizer Handsets the first in the period between October 1, 2019 and September 30, 2020 PARI will credit a bonus of [***] to Serendex.
All following twelve months periods shall commence every 1st of October. The bonus shall be calculated according to the following formula: Number of ordered PARI Products x purchase price x percentage of price reduction = bonus. For example: If
Serendex purchased [***] Nebulizer Handsets in an twelve months’ period as described above the bonus for that twelve months’ period will be: [***]. 

Table 2. Price Reductions for Devices and eBase Starter Kits 
  

					
	 Volume of Devices and eBase Starter Kits (units) purchased in a twelve
month period as
described above
	  	Percentage price
reduction	 
	 [***]
	  	 	[***	] 
	 [***]
	  	 	[***	] 
	 [***]
	  	 	[***	] 

  
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 Table 3. Price Reductions for Nebulizer Handsets 

 

					
	 Volume of Nebulizer Handsets (units) purchased in a twelve month period
as
described above
	  	Percentage price
reduction	 
	 [***]
	  	 	[***	] 
	 [***]
	  	 	[***	] 
	 [***]
	  	 	[***	] 

 (d) Comparable Nebulizer Device. Upon reasonable request by either Party the
Parties shall negotiate in good faith an additional adjustment of the Prices of the Device, if the price at which any comparable Nebulizer device (which is based on the eBase controller and has a comparable configuration and a comparable technical
performance) is sold by PARI to a wholesaler, or any other third party in the respective country in transactions with terms and conditions comparable to the terms and conditions of this Agreement and the License Agreement, and in each case based on
comparable sales volumes and indications, differs significantly from the Prices. Such prices shall not include any maintenance, support and other services to be provided by any PARI distributor, but shall include services provided by PARI to its
distributor. 
 (e) Distribution Network. Notwithstanding anything to the contrary in this Agreement or the
License Agreement, the Parties acknowledge that PARI has established a network of distributors. Serendex will use its best efforts to utilize that existing network or propose additional distributors to operate in comparable manner pursuant to
comparable terms. The distributors do not provide any support services unless otherwise agreed to in writing by the Parties. 
 If Serendex
requests support services for Europe and ROW, then Serendex shall pay, in addition to the prices above, a fair and equitable allocation of that portion of any distributor mark-up associated with product
servicing and support. 
 4.2 Invoicing. Except as otherwise set forth in Article 6 of this Agreement, PARI
shall invoice Serendex when PARI ships the PARI Products pursuant to the Purchase Orders. Subject to the terms and conditions of this Agreement, Serendex shall pay all undisputed invoices for the PARI Products delivered and accepted in accordance
with Section 7.4 within thirty (30) calendar days after the date of shipment. 
 4.3 Payment. 

(a) Payment Type. All payments pursuant to this Agreement for the PARI Products shall be paid to the address
listed on the applicable invoice. 
 (b) Withholding of Taxes. Serendex may withhold from payments due to PARI
amounts for payment of any withholding tax that is required by law to be paid to any taxing authority with respect to such payments. Serendex shall provide to PARI all necessary documents and correspondence and written evidence to demonstrate the
payment of such tax, and shall also provide to PARI any other cooperation or assistance on a reasonable basis as may be necessary to enable PARI to claim exemption from such withholding taxes and to receive a full refund of such withholding tax or
claim a tax credit. 
 4.4 Royalties. Article 6 of the License Agreement shall remain unchanged. 

  
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	5.	REGULATORY 

 5.1 Regulatory Assistance. The Parties shall
cooperate in good faith to obtain any Regulatory Approvals for the use of PARI Products with Serendex Products. Sections 3.1.1(a) through (d) of the License Agreement shall apply. 

5.2 Reimbursement Assistance. The Parties shall cooperate in good faith to obtain reimbursement of PARI Products
with the Serendex Product in those countries or territories where applicable. Each Party shall provide to the other reasonable regulatory and technical information relating to the PARI Products and/or components thereof or the Serendex Products
and/or components thereof, as applicable, as reasonably requested by a payor source (without compromising confidentiality and in compliance with all applicable laws). 

5.3 Safety Data Exchange Agreement. Within 120 days after submission to a Regulatory Authority for Marketing Approval in
any given country of the Serendex Product, the Parties shall enter, with respect to such country, into a safety data exchange agreement governing the safety data exchange, adverse event reporting, patient support and management of patient compliance
relating to the Device, Device Accessories and Drug Product (each a “Safety Data Exchange Agreement”). 

5.4 Recall. 

(a) PARI Product. 

(1) Each Party shall promptly notify the other Party in writing if any Regulatory Authority or other governmental
agency having jurisdiction requests or orders it to conduct a Recall of any PARI Product, or if PARI determines to undertake a Recall of any PARI Product voluntarily. Prior to the beginning of any such Recall, the Parties agree to discuss the Recall
process. Promptly after being notified of such Recall, but in no event later than may be required to permit such Party conducting such Recall to meet Applicable Laws and Standards, the other Party shall provide the Party conducting such Recall with
reasonable assistance in connection with such Recall as requested by the Party conducting such Recall. 
 (2) If PARI
is required or determines to effect any such Recall, then PARI shall solely manage such Recall and be responsible for (i) the cost of notifying end users; (ii) costs associated with the collection and shipment from end users of the PARI
Product(s) subject to such Recall; and (iii) costs of replacing such PARI Product(s), including the cost of shipping the replacement PARI Product(s) to the affected end users. 

(3) In the event that the Serendex Product is recalled and as a consequence the FDA or other Regulatory Authority also
requires the Device be retrieved or recalled for any reason, then Serendex will bear the costs (x) of notifying end users; (y) costs associated with the collection and shipment from end users of the

  
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PARI Product(s) subject to such Recall; and (z) costs of replacing such PARI Product(s), including the cost of shipping the replacement PARI Product(s) to the affected end users. 

(b) Serendex Product. Serendex shall promptly notify PARI in writing if any Regulatory Authority or other
governmental agency having jurisdiction requests or orders it to conduct a Recall of any Serendex Product, or if it determines to undertake a Recall of any Serendex Product voluntarily. Prior to the beginning of any such Recall, the Parties agree to
discuss the Recall process. Serendex shall solely manage such Recall and be responsible for (i) the cost of notifying end users; (ii) costs associated with the collection and shipment from end users of the Serendex Product subject to such
Recall; and (iii) costs of replacing such Serendex Product, including the cost of shipping the replacement Serendex Product(s) to the affected end users. 
  

	6.	MANUFACTURE AND SUPPLY OF PARI PRODUCTS 

 6.1 General.
During the Term of this Agreement, PARI shall use commercially reasonable efforts to supply 100% of Serendex’s, its Affiliates’ and Permitted Sublicensees’ forecasted volume requirements for the Device and related Accessories and
Serendex, its Affiliates and Permitted Sublicensees shall purchase 100% of their volume requirements for the Device and related Accessories from PARI. 

6.2 Manufacture of PARI Products. PARI shall manufacture all PARI Product(s) in accordance with the applicable
Device Specifications and Applicable Laws and Standards. Within 180 days after submission to a Regulatory Authority for Marketing Approval in any given country of the Serendex Product, the Parties will enter into two substantially equivalent quality
agreements (one to cover the US/Canada and the other for ROW) on the change control processes, GMP, quality inspection rights, quality system regulations, other standards and procedures for manufacturing and supplying the Device and the Device
Accessories as required by Applicable Laws and Standards customary for similar agreements (each a “Quality Agreement”). 

6.3 Modifications. Any significant modification(s) to the Device Specifications which (a) lead to the change
of the revision status of the item number of at least one (1) of the following assemblies: (i) the Nebulizer Handset, (ii) the connection cord, (iii) the controller, and/or (iv) the instructions for use, and therefore affect
the Regulatory Approval of the Device as used with the Drug Product; or (b) have a material adverse effect on the development of the Device, or the manufacture thereof, including without limitation the quality, reliability, robustness or user
interface of the Device, or which would otherwise have a material adverse effect on the Drug Product when used with the Device; shall be subject to the Parties’ written agreement prior to the implementation of such significant modifications,
not to be unreasonably be withheld, conditioned or delayed, provided, however, that if Serendex has not responded to PARI in writing within 10 Business Days of receipt of PARI’s notice regarding such modifications, then Serendex shall be deemed
to have approved such modifications. If Regulatory Authorities require the Device to be included under the MAA, (i) Serendex will support PARI in accommodating such requirement; and (ii) the Parties will work in good faith to allow for
PARI to implement any necessary changes to the Device accordingly, including any changes necessary as a result of the requirements of manufacturing scale-up, corrective and preventative actions (CAPAs), and
market feedback during the commercial phase. 
 6.4 Forecasts. Unless otherwise agreed to by the Joint Steering
Committee, after submission to a Regulatory Authority for Marketing Approval of the Serendex Product in any given country but no less than nine (9) months prior to First Commercial Sale in such country and thereafter

  
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on a quarterly basis during the Term, at least ten (10) Business Days before the end of each calendar quarter, Serendex shall provide PARI with its good faith, reasonable written projections
(broken down by Devices, eBase Starter Kits, Nebulizer Handsets and Device Accessories; each on a country-by-country basis) of the anticipated total market requirements
of PARI Products for each country in the Territory (“Forecast”), on a monthly basis during the one (1)-year period immediately following the calendar quarter in which such projection is issued. 

Depending on the cumulative amount of PARI Products in the Forecast different portions of the Forecast are fully binding upon Serendex or are non-binding (i.e. for information to allow for PARI’s production planning) subject to Section 6.6 (a): 
  

	 	(a)	If the twelve months Forecast indicates that less than [***] of PARI Products will be ordered by Serendex during the total twelve months’ period covered by the Forecast the first six (6) months of the Forecast
shall be binding upon Serendex and the second six (6) month shall be non-binding. 

  

	 	(b)	If the twelve months Forecast indicates that [***] or more PARI Products will be ordered by Serendex during the total twelve months’ period covered by the Forecast the total Forecast (i.e. reflecting the full
twelve months) shall be binding upon Serendex. 

 6.5 Initial Purchase Orders for PARI Products.
No later than one (1) year prior to the earliest anticipated approval date by the Regulatory Authority of a MAA in any given country of the Serendex Product, Serendex shall provide PARI with a PARI Product purchase order for a quantity of
Devices, eBase Starter Kits, Nebulizer Handsets and Device Accessories by item number (each an “Initial Purchase Order”). PARI shall produce sub-components for Devices and Nebulizer Handsets
as specified in the Initial Purchase Order. Such sub-components shall not be labeled with a trademark or according to the branding strategy until Serendex and PARI will have mutually agreed and confirmed in
writing the labeling of the Devices and Nebulizer Handsets. The shipment date of the Devices and Nebulizer Handsets covered by such Initial Purchase Order shall allow PARI a lead time of one hundred eighty (180) days from the date of written
agreement on the labeling of the Device and Nebulizer Handset for completing the finished components. Notwithstanding the above, if requested in writing by Serendex as an amendment to the Initial Purchase Order, PARI shall complete production and
ship a reasonable portion as requested in the amendment of the PARI Products ordered in the Initial Purchase Order within one hundred eighty (180) days of the receipt of such amendment. The amendment shall include the requested labeling of the
Device including the Nebulizer Handset, packaging, and instruction for use. The remaining balance of the Initial Purchase Order shall be shipped within one hundred eighty (180) days from the date of written confirmation by Serendex on the
labeling of the Device and Nebulizer Handset. For the avoidance of doubt, if Serendex requests the production of a reasonable portion of the PARI Products ordered in the Initial Purchase Order before the date of written agreement on the labeling of
the Device and Nebulizer Handset, Serendex shall pay for such portion of the Initial Purchase Order as set forth below regardless of whether the labeling of the Device and Nebulizer Handset changes for any reason. Notwithstanding the foregoing, if
PARI needs to change the labeling upon request by Serendex or any relevant Regulatory Authority, then Serendex shall promptly reimburse PARI for the additional cost incurred by PARI and any resulting delay in shipment shall not be deemed a breach of
this Agreement and such late shipment shall not be included to determine a Failure Event. PARI shall store such PARI Products until such time as PARI delivers such PARI Products on the dates and to the locations to be provided by Serendex in written
instructions to PARI prior to the First Commercial Sale. 

  
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Notwithstanding Section 4.2 above, PARI shall provide Serendex with an invoice for the PARI Products manufactured by PARI pursuant to such Initial Purchase Order upon receipt and
confirmation of the Initial Purchase Order and Serendex shall pay fifty percent (50%) of the invoice submitted by PARI for the Initial Purchase Order within thirty (30) calendar days after the date of invoice and the remaining fifty (50%) upon
shipment of PARI Products ordered in such Initial Purchase Order. 
 6.6 Subsequent Purchase Orders. 

(a) PARI shall supply PARI Products to Serendex in accordance with the terms and conditions of this Agreement, and in
accordance with the purchase orders submitted to PARI by Serendex (the “Purchase Orders”). Each Purchase Order shall include item numbers and quantity, delivery location(s), contact information and shipment date(s). PARI shall ship
the quantity of PARI Products specified in each Purchase Order no less than one hundred twenty (120) days after the date and confirmation of such Purchase Order by PARI, unless otherwise agreed to by PARI and Serendex; provided, however, that
no such Purchaser Order shall have a shipment date prior to the 120th day following the date of shipment of PARI Products ordered in the Initial Purchase Order. PARI shall use commercially
reasonable efforts to accept and fill Purchase Orders placed by Serendex that are in excess of the forecasted quantities for such time period. PARI shall notify Serendex within 10 Business Days if it cannot meet the requested shipment date for the
excess quantities; provided, however that failure by PARI to fulfill such excess quantities shall not be deemed a breach under this Agreement. Any special or customized labeling or shipment requirements will need to be discussed and agreed to by the
Parties along with any associated extensions of timelines and added costs billed to Serendex. 
 (b) PARI’s sale
of PARI Products hereunder shall be subject to the terms and conditions of this Agreement and not to any terms and conditions stated on any Purchase Order, PARI’s written acceptance of a Purchase Order or other document not effectively amending
this Agreement, except insofar as such Purchase Order or other document establishes the quantity, delivery date, specific shipping requirements and destination of shipment of PARI Products ordered. Any additional, inconsistent or different terms and
conditions contained in such other documents are hereby expressly rejected. 
 (c) Rush orders for PARI Products
requesting a delivery date sooner than one hundred twenty (120) days after the date of such Purchase Order are subject to PARI’s acceptance and written confirmation and may incur additional charges. 

6.7 Safety Stock. For the purpose of guarding against unexpected changes in market demand or unforeseen
manufacturing failures, delays and shortfalls, the Parties agree to maintain safety stock of the Devices or components to make the Devices (the “Safety Stock”). PARI agrees to maintain, at its own cost and expense, Safety Stock of the
Devices or components to make the Devices, equal to three (3) months’ supply as set forth in the most current Forecast but excluding the demand for PARI Products to (i) build up Safety Stock, (ii) fill the distribution chain, or
(iii) any other temporary demand for additional devices. PARI shall have such Safety Stock in place beginning eighteen (18) months after the first Marketing Approval of the Serendex Product. Serendex agrees to build up and maintain, at its
own cost and expense, Safety Stock of the Devices equal to three (3) months’ supply as set forth in the most current Forecast. Serendex shall have such Safety Stock in place beginning one (1) year after the first Marketing Approval of
the Serendex Product. The time period to build up of the Safety Stock may be extended if the actual market demands for PARI Products exceed the twelve months binding Forecast. PARI may only use the 

  
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Safety Stock to fulfill Purchase Orders from Serendex in case of supply shortages and will have to fill up the Safety Stock again within six (6) months. Similarly, Serendex may only use its
own Safety Stock in case PARI is not able to fulfil Purchase Orders on time and will have to fill up the Safety Stock again within nine (9) months. Starting six (6) months prior to the expiration of the Term of this Agreement the Parties
shall be allowed to reduce their Safety Stock so that no Safety Stock may exist at the end of the Term. 
 6.8
Supply Shortage. In the event of any supply interruption or inadequate quantities of the Device available to fulfill Serendex’s requirements, PARI shall provide to Serendex not less than Serendex’s pro rata portion of all available
quantities of devices based on then-pending forecasts of all PARI customers. 
 6.9
Back-Up License to Manufacture 
 (a) Notice of Supply
Interruption. In the event of any planned or unexpected interruption of PARI’s ability to supply Devices, Nebulizer Handsets and eBase Starter Kits in accordance with this Agreement for any reason, PARI shall promptly notify Serendex. Such
notification shall be for the Parties’ planning purposes only and shall not in itself constitute a Failure Event if none of the conditions described in Section 6.9(b) has been met. 

(b) Failure Event. The Parties acknowledge the possibility that one or more of the following events (each, a
“Failure Event”) may occur: 
 (1) PARI undergoes a voluntary or involuntary dissolution; 

(2) PARI ceases to conduct business in the normal course, becomes insolvent, files for bankruptcy, is subject to a
bankruptcy proceeding or otherwise becomes bankrupt, makes a general assignment for the benefit of creditors, admits in writing its inability to pay its debts as they are due, permits the appointment of a receiver for its business or assets, avails
itself of or becomes subject to any proceeding under any statute of any governing authority relating to insolvency or the protection of rights of creditors; or 

(3) PARI’s failure to supply at least eighty percent (80%) of the ordered quantities of Devices, Nebulizer
Handsets and eBase Starter Kits (which, for purposes of calculating a Failure Event under this subsection (3), shall be calculated individually) set forth in all accumulated Purchase Orders (but only to the extent each such Purchase Order is within
the applicable forecasted amount) in any two (2) consecutive quarters; provided that PARI shall be permitted to use Safety Stock to avoid an incomplete Purchase Order, in which case such Purchase Order shall be deemed complete and not be
counted towards the occurrence of a Failure Event. 
 Notification. PARI shall promptly notify Serendex in writing
upon the occurrence of any Failure Event set forth in subsection (1) or (2) of this Clause (b), and Serendex may notify PARI in writing upon the occurrence of an event set forth in subsection (3) of this Clause (b) (each such notice,
a “Notice of Failure Event”). 
 (c) Cure of Failure Events. Should a Failure Event occur,
PARI shall during the Cure Period provide Serendex a written proposal which provides for a cure of the Failure Event, including implementation of a contingency plan to the extent its provisions apply to the Failure Event.

  
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Serendex will give good faith consideration to PARI’s written proposal and if Serendex agrees the proposal is reasonably adequate, the Failure Event will be deemed resolved. If the Failure
Event set forth in Section 6.9(b)(3) occurs, PARI shall provide Serendex, prior to the end of the Cure Period, a written proposal which includes: (i) a statement of the exact amount of Safety Stock and other Devices, Nebulizer Handsets and
eBase Starter Kits remaining in PARI’s inventory; (ii) the current and expected orders for Devices; and (iii) PARI’s plans for remedying the Failure Event. Such remedies may include, but are not limited to, PARI’s
implementation of a contingency plan, establishment of a new manufacturing line at an alternate PARI facility or PARI establishing an agreement with a Third Party to begin manufacturing. Serendex will have ten (10) Business Days to review and
give good faith consideration to PARI’s written proposal and, if Serendex agrees the proposal is reasonably adequate, approve PARI’s proposal for cure. 

(d) If Serendex reasonably believes that PARI’s proposal with respect to any Failure Event is not adequate to
restore continuity of supply, then the designated senior executives, officers or management of PARI and Serendex shall meet (in person or via phone) at a mutually acceptable time within ten (10) Business Days after Serendex’s rejection of
PARI’s cure proposal to discuss and attempt to resolve such Failure Event. If the outcome of such meeting(s) is not reasonably satisfactory to Serendex, then (1) PARI, upon Serendex’s written request within five (5) Business Days
after such meeting, will grant to Serendex a non-exclusive license, under the PARI Intellectual Property, to make the Devices, Nebulizer Handsets or eBase Starter Kits (but only those products which are
affected by the Failure Event) solely for use with the Serendex Products in the Serendex Field in the Serendex Territory, provided however that such license will only be granted with respect to such PARI Products (excluding Device Accessories) which
are actually affected by the Failure Event (the “Limited Manufacturing Back-Up License”); and (2) PARI agrees to provide (x) contacts to its suppliers of raw materials and
components, and (y) reasonable technical assistance to Serendex (and/or, in case that subsection (e) below applies, its designated contract manufacturer, but excluding a PARI Competitor) with respect to manufacturing the Devices, in each
case at Serendex’s reasonable request and at its expense (the foregoing information and technology to be defined as “PARI Property”); provided, however, that PARI makes no guarantee of any result for Serendex or that Serendex
will be able to manufacture or have manufactured the Devices. Serendex shall not have the right to provide any PARI Property to a PARI Competitor. 

(e) To the extent permitted by the TTP/PARI Agreement and subject to PARI’s written approval (not to be
unreasonably withheld), the Limited Back-Up License to Manufacture shall comprise rights to have made Devices (other than by a PARI Competitor) and be sublicensable; provided, however, that: (i) PARI
Property transferred to a Third Party to effectuate the Limited Manufacturing Back-Up License shall be subject to the provisions of Articles 10 and 12 and Serendex shall be responsible for any breaches
thereof; (ii) any sublicense to a Third Party by Serendex must expressly provide that the Third Party shall use the PARI Property only for the purpose of manufacturing the Devices for supply to Serendex; (iii) Serendex shall not enter into
an agreement with any Third Party for Device manufacture that contains performance criteria (lead time to a serial production, financial terms and other significant considerations) that are equal or worse than those offered by a Third Party
manufacturer suggested by PARI as part of the contingency plan pursuant to Section 6.9(c) if any; and (iv) Serendex shall not have the right to grant a sublicense of the Limited Manufacturing Back-Up
License to a PARI Competitor. 
 (f) In acknowledgment of PARI’s reasonable concerns over the protection of PARI
Property, Serendex shall not transfer, or cause to be transferred the proprietary aspects of manufacture of the Device’s or Nebulizer Handset’s aerosol heads pursuant to the Limited Manufacturing Back- Up License in the countries listed on
Exhibit C hereto, except to the extent such country no longer is listed on the TRIPS Priority Watch list. 

  
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 (g) Notwithstanding anything to the contrary in this
Section 6.9, if Serendex does not pay the royalties due under the License Agreement, then the Limited Manufacturing Back-Up License shall not, or shall not continue to, as applicable, be granted and
Serendex shall immediately cease, to the extent any such license was previously granted, to exercise such license rights. 

(h) Restrictions: End of Failure Event. The Limited Manufacturing
Back-Up License shall not include Serendex’s right to modify or improve Devices, except as required to resolve any safety concerns subject to (i) having obtained PARI’s prior written approval,
such approval not to be unreasonably withheld, and (ii) all ownership rights to such improvements and modifications will be exclusively owned by PARI, and Serendex will promptly transfer and assign any and all of its rights in such improvements
and modifications to PARI. If Serendex exercises the Limited Manufacturing Back-Up License and PARI subsequently regains the manufacturing ability necessary to manufacture and supply Devices to Serendex, then
(i) Serendex shall immediately return to obtaining supply of the Devices from PARI under this Agreement, provided that the foregoing shall not be construed to obligate Serendex to terminate its then existing supply agreement on less than ninety
(90) days’ notice; (ii) Serendex shall immediately cease (and cause any Third Party manufacturing Devices, Nebulizer Handsets and eBase Starter Kits on behalf of Serendex to cease) the manufacturing of the Devices, Nebulizer Handsets
and eBase Starter Kits; and (iii) the Limited Manufacturing Back-Up License shall automatically terminate without any further action by any Party. 

(i) Option ID Use Another Nebulizer. In case the preconditions for Serendex’s right to obtain the Limited Back-Up License to Manufacture from PARI according Section 6.9(d) above are given and for the duration of such Limited Back-Up License to Manufacture according to
Section 6.9(h) above, Serendex shall have the option, upon Serendex’s written notification within five (5) Business Days after the meeting of the Parties set forth in Section 6.9(d) above, to be free to use another Nebulizer for
the delivery of the Drug Product within the Serendex Field instead of being granted the Limited Back-Up License to Manufacture. In case Serendex exercises its right to utilize another Nebulizer, during the
period of time in which the Limited Back-Up License to Manufacture would be effective according to Section (h) above, Section 3.4 of the License Agreement shall not be applicable. For the purpose of
clarification, in case Serendex exercises its option set forth herein, (i) the right to use another Device shall also be restricted to such PARI Products (excluding Device Accessories) which are actually affected by the Failure Event and
(ii) PARI shall not have any obligations with respect to PARI Property under Section 6.9(d)(2) above. 

(j) For clarity, Serendex shall remain responsible for its royalty obligations in accordance with the terms of the
License Agreement. Notwithstanding anything to the contrary contained herein, the Limited Manufacturing Back-Up License and related rights set forth in this Section 6.9 shall terminate concurrently with
any termination or expiration of the License Agreement. 
 6.10 Purchase Obligation. Within the EEA, Serendex
and its Sublicensees shall purchase (i) during the first five (5) years from the first Marketing Approval within the EEA 100%, and (ii) thereafter 80%, of their volume requirements for Nebulizers and related accessories for pulmonary
delivery of the Drug Product in the Indications from PARI. 

  
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 In the rest of the world outside the EEA, during the Royalty Period Serendex
and its Sub-licensees shall purchase 100% of their volume requirements for Nebulizers and related accessories for pulmonary delivery of the Drug Product in the Indications from PARI. 

6.11 Relationship to the License Agreement. The provisions of this Agreement shall replace and supersede
Sections 4.3 and Exhibit E of the License Agreement in their entirety. 
  

	7.	DELIVERY 

 7.1 Delivery. PARI shall deliver to Serendex all
PARI Products in conformance with each applicable Purchase Order. All deliveries of PARI Products shall be accompanied by any documentation that PARI customarily includes in shipments of such Device and/or Device Accessories. 

7.2 Shipping; Risk of Loss. All shipments for PARI Products will be made (x) EXW PARI’s facilities in
Germany or the United States, respectively (INCOTERMS 2010) by a common carrier selected by PARI. 
 7.3
Testing. PARI shall test the orders of PARI Product to be supplied to Serendex as set forth in the Quality Agreement. 

7.4 Acceptance. Serendex shall have a period of ten (10) Business Days from the date of receipt of any
shipment of the Device and/or Device Accessories to test for quality and quantity of the shipment and accept or reject such shipment. Serendex shall have the right to reject all or a portion of a shipment for any visible damage, or request for the
shipment of additional units to the extent there is a shortage in quantity. If Serendex rejects a shipment, it shall notify PARI in writing within such ten (10) Business Days, indicating the particular lot, date of delivery and the defective
nature of the Device. Upon PARI’s receipt of a rejection from Serendex and PARI’s acceptance in good faith of such a rejection, PARI shall, at the option of PARI, replace the Device and/or Device Accessory or replace the defective part or
component, in each case at PARI’s sole expense. In the event Serendex does not so notify PARI within ten (10) Business Days after its receipt of any shipment thereof, Serendex shall be deemed to have accepted such shipment and shall be
obligated to make payment therefor as provided in this Agreement. Thereafter, Serendex may return any PARI Product only pursuant to Section 8.3 below. 
  

	8.	REPRESENTATIONS AND WARRANTIES 

 8.1 Mutual Representations and
Warranties. Each Party hereby represents and warrants to the other Party as follows: 
 (a) Due
Authorization. Such Party has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder. 

(b) Enforcement of Obligations. This Agreement has been duly executed and delivered on behalf of such Party, and
constitutes a legal, valid, binding obligation, enforceable against such Party in accordance with its terms. 
 (c)
No Conflict. The execution and delivery of this Agreement and the performance of such Party’s obligations hereunder do not conflict with, or constitute a default or require any consent under, any contractual obligation of such Party.

  
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 8.2 Device Warranties. PARI represents, warrants and guarantees
that each unit of PARI Products supplied to Serendex: 
 (a) as of the time of the passing of risk, complies with the
applicable Device Specifications set forth in the applicable Territory-Specific Appendix; 
 (b) has been
manufactured in compliance with Applicable Laws and Standards; 
 (c) with respect to the durable components (eBase
Controller or AC power supply, nebulizer connection cord) of each Device, will have no material defect in workmanship for a period of at least twenty (24) months from the date of passing of risk; 

(d) with respect to each Nebulizer Handset and Device Accessory, will have no material defect in workmanship when the
Nebulizer Handset and Device Accessory is used by such end user for the first time, provided such Device Accessory has been properly transported, stored, used and maintained in accordance with any product user manual or the “Instructions for
Use” for the applicable Device Accessory; and 
 (e) is, upon passing of risk to Serendex, free and clear of all
security interests, liens and other encumbrances of any kind or character. 
 8.3 Warranty Replacement. PARI
shall be solely responsible for any warranty claim that it accepts which alleges that any PARI Product does not conform with any of the warranties described under Sections 8.2, by replacing the
non-conforming units. The Parties shall establish appropriate timelines for responding to warranty calls in the different countries within the Territory. PARI shall have the right to inspect defective Devices
and/or Device Accessories to determine the validity of warranty claims under this Section 8.3 or to comply with applicable Regulatory Requirements. 

8.4 Warranty Limitations or Disclaimers. The warranties, limitations and disclaimers described in this Article 8
are exclusive and supersede any other warranty limitations and disclaimers given by PARI or Serendex, whether written or oral. Except for the express warranties in Section 8.2, PARI makes no warranties of any kind with respect to any PARI
Product, whether express or implied, including, but not limited to, any implied warranties of merchantability, of fitness for a particular purpose, for any implied warranties arising from course of performance, course of dealing or usage of trade.
Serendex and its designees shall not make any representation or warranty on behalf of PARI that exceeds the express warranties in Section 8.2. 
  

	9.	INTELLECTUAL PROPERTY 

 9.1 Trademark. 

(a) License and Authorization. 

(1) Subject to the terms and conditions set forth in this Agreement, PARI hereby grants to Serendex and its designees,
a non-exclusive, nontransferable 

  
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right and license to use PARI’s trademark(s) set forth on Exhibit B attached hereto, in the Territory in connection with (w) the PARI Products, (x) the
Serendex Products offered by Serendex and its designees, and (y) any advertising or promotional materials associated therewith, in the manner mutually agreed to by the Parties pursuant to Section 3.4 of this Agreement, and
(z) packaging and prescribing information of PARI Products and Serendex Products. The license set forth herein shall immediately terminate upon expiration or sooner termination of this Agreement. 

(2) Subject to the terms and conditions set forth in this Agreement, Serendex hereby grants to PARI a non-exclusive, non-transferable right and license to use Serendex’s trademark(s) set forth on Exhibit B attached hereto, in the Territory in
connection with (w) the PARI Products, (x) the Serendex Products, and (y) any advertising or promotional materials associated therewith, in the manner mutually agreed to by the Parties pursuant to Section 3.4 of this Agreement,
and (z) packaging and prescribing information of PARI Products and Serendex Products. The license set forth herein shall immediately terminate upon expiration or sooner termination of this Agreement. 

(b) Notices. Each of PARI and Serendex agree to use commercially reasonable efforts to mark all materials,
including packaging, advertising and promotional materials, that incorporate the trademarks of the other Party hereto that are licensed above in Section 9.1(a) with the symbol TM or ®, as
applicable, and the following attribution notice: “[Insert applicable trademark from Exhibit B] is a trademark of [insert applicable Party that owns the relevant trademark]”. In
addition, each Party shall comply with any additional requirements established by the other Party with respect to the use of its trademarks. 

(c) Ownership. Each Party represents and warrants that it owns all right, title and interest in and to its
trademarks set forth in Exhibit B. Neither Party shall challenge, cause others to challenge or assist in any challenge to the validity of the other Party’s trademarks, any registrations thereof or the ownership
thereof. Each of Serendex and PARI shall be solely responsible for taking such actions as it deems appropriate to obtain trademark, service mark or copyright registration for its trademarks. All uses of or references to each Party’s trademarks
shall inure to the benefit thereof, and all rights with respect to such Party trademarks not specifically granted in this Agreement shall be and are hereby reserved to such Party. 

(d) Infringement. If either Party learns of any activity by a Third Party which might constitute an infringement
of the other Party’s rights in any of its trademarks, or if any Third Party asserts that a Party’s use of the other Party’s trademarks constitutes unauthorized use or infringement, such Party shall so notify the other Party. The
notifying Party shall make all reasonable efforts to assist the other Party, at the other Party’s expense and request, with any litigation concerning such trademarks, including providing such evidence and/or expert assistance as the notifying
Party may have within its control. 
 (e) Quality Control. Each Party hereto acknowledges and agrees that the
other Party shall be entitled to monitor the use of its respective trademarks pursuant to this Agreement. If a Party determines that any of its trademarks is not being used properly, it shall so notify the other Party in writing or through the Joint
Advisory Committee and such other Party shall take steps to: (i) reassure the notifying Party that the trademark usage is proper or (ii) comply with any changes necessary to address the notifying Party’s concerns. 

  
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	10.	CONFIDENTIALITY 

 Article 9 of the License Agreement is hereby
incorporated herein by reference and shall govern all Confidential Information exchanged between the Parties under this Agreement. 
  

	11.	INDEMNIFICATION 

 11.1 General. Article 15 of the License
Agreement is incorporated herein by reference as if fully set forth herein and shall govern the indemnification obligations of the Parties under this Agreement. Each party shall maintain product liability insurance with a coverage of at least Euro
2.0 Million per occurrence and Euro 10.0 Million in total per year. 
 11.2 Liability. Article 14 of the
License Agreement is incorporated herein by reference as if fully set forth herein. 
  

	12.	TERM 

 12.1 Term. This Agreement shall become effective
upon the Effective Date and shall remain in full force and effect until the expiration of the Royalty Period (the “Term”). 

12.2 Termination. 

(a) By Mutual Agreement. This Agreement may be terminated at any time upon the mutual written agreement of the
Parties. 
 (b) For Insolvency. To the extent permitted by law, this Agreement may be terminated by either
Party in the event the other Party files an application for commencement of bankruptcy, civil rehabilitation, corporate reorganization, corporate liquidation or special liquidation procedures, or any mailing of order or notice of attachment or
provisional attachment on any assets of such other Party, or any other insolvency. 
 (c) For Cause. If a
Party is in material breach of this Agreement, then the non-breaching Party may deliver notice of such material breach to the other Party. For all material breaches other than a failure to make a payment set
forth in this Agreement, the breaching Party shall have ninety (90) days to cure such material breach from the receipt of the notice or to dispute. With respect to any failure to make a payment set forth in this Agreement, the breaching Party
shall have ten (10) Business Days from the receipt of the notice to dispute or cure such non-payment. If the Party receiving notice of material breach or failure to make a payment fails to cure that
material breach or failure to make a payment within the applicable period set forth above, then the non-breaching Party may terminate this Agreement immediately on written notice of termination. 

(d) Termination of License Agreement. Either Party may terminate this Agreement in case the License Agreement is
terminated. 
 12.3 No Waiver. The termination or expiration of this Agreement, as the case may be, shall not
act as a waiver of any breach of this Agreement and shall not act as a release of either Party from any liability or obligation incurred under this Agreement through the date of such termination or expiration, including payments due PARI pursuant to
this Agreement. 

  
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 12.4 Consequences of Termination. 

(a) Reimbursement of Safety Stock. If Serendex terminates this Agreement, then Serendex shall reimburse PARI no
later than ten (10) Business Days after the effective date of termination of this Agreement for all reasonable costs related to the remaining Safety Stock, other PARI Products manufactured and raw material / unfinished goods specific for the
Device by PARI pursuant to Purchase Orders submitted by Serendex in accordance with this Agreement that, in each case, cannot be reallocated or reused by PARI through PARI’s use of commercially reasonable efforts to do so. However, PARI shall
not be entitled to reimbursement other than for Safety Stock, other PARI Products manufactured and raw material / unfinished goods specific for the Device which can be used by and delivered to Serendex at Serendex request if the Agreement is
terminated due to any material breach on the part of PARI (or anyone who PARI is responsible for). 
 (b)
Survival. Sections 4.2, 4.3, 8.2, 8.3, 8.4, and 12.4, and Articles 1, 10, 11 (with respect to any Claim that is attributable to any cause that occurs under this Agreement prior to its expiration or termination, as applicable) and 13 of
this Agreement shall survive expiration or termination of this Agreement for any reason. 
  

	13.	MISCELLANEOUS 

 13.1 Notices. With respect to notices,
Section 13.7 of the License Agreement shall apply. 
 13.2 Force Majeure. No failure or omission by either
Party in the performance of any obligation under this Agreement shall be deemed a breach of this Agreement or create any liability if the same shall arise from any cause or causes beyond the control of such Party including, but not limited to, the
following which, for the purposes of this Agreement, shall be regarded as beyond the control of the Party in question: (a) any act or omission of any government; (b) any future rule, regulation or order issued by any governmental authority
or by any officer, department, agency, or instrumentality thereof which makes such performance impossible or commercially unreasonable; or (c) any Act of God, fire, storm, flood, earthquake, accident, war, terrorism, rebellion, insurrection,
riot, invasion, strike, and lockout. 
 13.3 Relationship of the Parties. In making and performing this
Agreement, the Parties are acting, and intend to be treated, as independent entities and nothing contained in this Agreement shall be construed or implied to create an agency, partnership, joint venture, or employer and employee relationship between
or among any of the Parties. Except as otherwise provided herein, no Party may make any representation, warranty or commitment, whether express or implied, on behalf of or incur any charges or expenses for or in the name of any other Party. No Party
shall be liable for the act of any other party unless such act is expressly authorized in writing by such Party. 

13.4 Waivers and Amendments. This Agreement may be amended or modified, and the terms and conditions hereof may
be waived, only by a written instrument signed by the Parties hereto or, in the case of a waiver, by the Party waiving compliance. No delay on the part of any Party in exercising any right, power or privilege hereunder shall operate as a waiver
thereof, nor shall any waiver on the part of any Party of any right, power or privilege hereunder, nor any total or partial exercise of any other right, power or privilege hereunder preclude any other or further exercise thereof or the exercise of
any other right, power or privilege hereunder. The rights and remedies herein provided are cumulative and are not exclusive of other rights or remedies which any Party may otherwise have. 

13.5 Assignment. This Agreement shall not be assignable by either Party without the prior written consent of the
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conditioned, except that without consent either Party may assign or transfer the rights and obligations of this Agreement to any Affiliate or to any successor to its business that related to the
subject matter of this Agreement (whether by sale of assets or equity, merger, consolidation or otherwise) provided, however, that such assignment or transfer by Serendex to a PARI Competitor shall require the prior written consent of PARI, to be
granted in its sole discretion. This Agreement shall inure to the benefit of and be binding upon the Parties hereto and their respective successors and permitted assigns. Section 13.10 of the License Agreement shall apply mutatis mutandis. Any
assignment in contravention of the foregoing shall be null and void. 
 13.6 Choice of Law. This Agreement is
construed in accordance with, and its performance is governed by, the laws of Switzerland, excluding its or any other jurisdiction’s choice of law principles. The UN Convention on contracts for the International Sale of Goods shall not apply to
this Agreement. 
 13.7 Dispute Resolution. 

(a) Informal Resolution. Subject to Section 13.8, in the event of any controversy, dispute or claim arising
out of, in connection with, or in relation to the interpretation, performance, or alleged breach of this Agreement (the “Dispute”), prior to instituting any arbitration on account of such Dispute, the Parties shall attempt in good faith to
settle such Dispute first by negotiation and consultation between themselves, including referral of such Dispute to the Chief Executive Officer of Serendex and the President of PARI. In the event said executives are unable to resolve such Dispute or
agree upon a mechanism to resolve such Dispute within thirty (30) days of the first written request for dispute resolution under this Section 13.7(a), then the Parties shall resolve all such Disputes in accordance with
Section 13.7(b). 
 (b) Venue. If the Parties fail to reach agreement with respect to a dispute or
difference in an amicable way, any disputes arising out of or in connection with this Agreement, including any questions regarding its existence, validity or termination, shall be brought to court. If the dispute is brought to court by Serendex,
then such proceedings shall be subject to the exclusive jurisdiction of the Munich District Court (Landgericht München 1), Germany. If the dispute is brought to court by PARI, then such proceedings shall be subject to the exclusive
jurisdiction of the City Court of Copenhagen, Denmark. 
 13.8 Injunctive Relief. Each of the Parties agrees
that if certain material obligations under this Agreement, including without limitation those set forth in Article 9 or Article 10 above, are not performed in accordance with their specific terms or are otherwise breached, (a) severe and
irreparable damage would occur, (b) no adequate remedy at law would exist and (c) damages would be difficult to determine. Each of the Parties agrees that, in such case, the injured Party or Parties shall be authorized and entitled to
obtain from any court of competent jurisdiction injunctive relief, whether preliminary or permanent, as well as any other relief permitted by applicable law, and the breaching Party shall waive any requirement that such Party or Parties post bond as
a condition for obtaining any such relief. 
 13.9 Entire Agreement. This Agreement and the Exhibits and
Appendices to this Agreement, the License Agreement between the Parties contain the entire understanding of the Parties hereto with respect to the subject matter contained herein and supersede and cancel all prior agreements, negotiations,
correspondence, undertakings and communications among the Parties, oral or written, with respect to such subject matter. The License Agreement shall remain in full force and effect except for those provisions that are inconsistent with the terms and
conditions under this Agreement, in which event the terms and conditions under this Agreement shall control. 

  
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 13.10 Severability. Both Parties hereby expressly state that it
is the intention of neither Party to violate any law. If any of the provisions of this Agreement are held to be void or unenforceable, then such void or unenforceable provisions shall be replaced by valid and enforceable provisions which will
achieve as far as possible the economic business intentions of the Parties. 
 13.11
Section Headings. The section headings contained in this Agreement are for the purpose of convenience and are not intended to define or limit the contents of such sections. 

13.12 Further Assurances. Upon the reasonable request of either Party, the other Party shall execute any
additional certificates or other documents that may be reasonably necessary to fully implement this Agreement. 

13.13 Legal Counsel. Each party hereby represents and acknowledges that it has had the opportunity to seek
independent tax and legal advice from attorneys of such party’s choice with respect to the advisability of executing this Agreement. The rule of construction that a written agreement is construed against the party preparing or drafting the
agreement shall specifically not be applicable to the interpretation of this Agreement. 
 13.14 Counterparts.
This Agreement may be executed in counterparts and each such counterpart shall be deemed an original hereof. Delivery of an executed counterpart of a signature page to this Agreement by facsimile or by email in portable document form (.pdf) shall
constitute delivery of a manually executed counterpart of this Agreement. 
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 IN WITNESS WHEREOF, each Party hereto has executed or caused this Commercialization
Agreement to be executed on its behalf as of the Effective Date. 
  

					
	PARI Pharma GmbH
		
	By:	 	 /s/ Dr. Martin Knoch

		 	Name:	 	Dr. Martin Knoch
		 	Title:	 	President
	
	Serendex, Pharmaceuticals A/S
		
	By:	 	 /s/ Kim Arvid Nielsen

		 	Name:	 	Kim Arvid Nielsen
		 	Title:	 	CEO

  
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 EXHIBIT A 

Device 

“Device” components are as follows: 
  

	 	•	 	Controller with display (without monitoring capabilities) 

  

	 	•	 	Handheld Nebulizer Handset with aerosol head 

  

	 	•	 	Nebulizer connection cord 

  

	 	•	 	AC power supply 

  

	 	•	 	Carrying case 

  

	 	•	 	All outer packaging 

  

	 	•	 	Instructions for Use 

 Nebulizer Handset 

“Nebulizer Handset” components are as follows: 
  

	 	•	 	Handheld nebulizer handset with aerosol head 

  

	 	•	 	Packaging 

  

	 	•	 	If required: instructions for use 

  
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 EXHIBIT B 

Trademarks 
 PARI Marks:

 1. EFLOW TECHNOLOGYTM word mark and logo 

 
 

 
 2. Device Brand (TBD) word mark and logos 

Serendex Marks: 
 [TO BE PROVIDED][to be completed]

  
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 EXHIBIT C 

TRIPS Priority Watch List 

China 
 Russia 

Argentina 
 Chile 

Algeria 
 India 

Israel 
 Canada 

Thailand 
 Pakistan 

Venezuela 
 Indonesia 

Ukraine 

  
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 APPENDIX A 

Territory-Specific Appendices 

[To be attached when agreed to by the Parties in accordance with the terms of this Agreement.] 

  
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