Document:

EX-4.12

 Exhibit 4.12 

[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such
excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed. 
 MANUFACTURING
AND SUPPLY AGREEMENT 
 (“Agreement”) 

between 
 Ascendis Pharma A/S

 Tuborg Boulevard 12 
 2900
Hellerup 
 Denmark 

(hereinafter referred to as “Ascendis”) 

and 
 CARBOGEN AMCIS AG

 Hauptstrasse 171 
 CH4416
Bubendorf 
 Switzerland 

(hereinafter referred to as “Carbogen”) 

(hereinafter individually referred to as “Party” and collectively as “the Parties”) 

							
	 1.
	  	 INTRODUCTION
	  	 	3	 
	 2.
	  	 DEFINITIONS
	  	 	3	 
	 3.
	  	 SUBJECT MATTER OF THE AGREEMENT
	  	 	6	 
	 4.
	  	 OBLIGATIONS OF THE PARTIES
	  	 	6	 
	 5.
	  	 GOVERNANCE
	  	 	8	 
	 6.
	  	 COMMUNICATIONS
	  	 	8	 
	 7.
	  	 MATERIALS AND SUBCONTRACTING
	  	 	9	 
	 8.
	  	 FORECAST AND PURCHASE ORDERS
	  	 	9	 
	 9.
	  	 BATCH SIZE AND CAPACITY
	  	 	11	 
	 10.
	  	 DELIVERY AND RELEASE
	  	 	11	 
	 11.
	  	 PURCHASE PRICE AND PAYMENT TERMS
	  	 	12	 
	 12.
	  	 REGULATORY COMPLIANCE AND SUPPORT
	  	 	13	 
	 13.
	  	 NON-COMPLIANCE
	  	 	13	 
	 14.
	  	 RECALL
	  	 	14	 
	 15.
	  	 TERM AND TERMINATION
	  	 	14	 
	 16.
	  	 CONFIDENTIALITY
	  	 	16	 
	 17.
	  	 INTELLECTUAL PROPERTY RIGHTS
	  	 	17	 
	 18.
	  	 INSURANCE AND LIABILITY
	  	 	19	 
	 19.
	  	 REPRESENTATIONS AND WARRANTIES
	  	 	19	 
	 20.
	  	 ASSIGNABILITY AND SUB-CONTRACTING
	  	 	20	 
	 21.
	  	 FORCE MAJEURE
	  	 	21	 
	 22.
	  	 ARBITRATION AND LAW
	  	 	21	 
	 23.
	  	 MISCELLANEOUS
	  	 	22	 

 APPENDICES 
  

	1	 Approved manufacturing sites 

	2	 Products 

	3	 Purchase Price 

	4	 Quality Agreement 

	5	 Specifications 

	6	 Batch sizes 

	7	 Other Services 

	8	 Materials 

	9	 List of applicable Intellectual Property Rights 

  
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	1.	 INTRODUCTION 

WHEREAS: 
  

	 	(A)	 Ascendis and Carbogen entered into a Master Services Agreement dated 15 February 2010 pursuant to which
Ascendis and Carbogen agreed to collaborate on the development and manufacture of linker reagents; 

  

	 	(B)	 The Parties have agreed to enter into a commercial supply partnership with the objective to ensure delivery of
agreed quantities of Product of the specified quality at agreed times. 

  

	 	(C)	 The Parties have agreed to enter into this Manufacturing and Supply Agreement to set forth the general terms
and conditions on which the supply of different Products and additional services will be carried out. 

  

	2.	 DEFINITIONS 

“Agreement” shall mean this Manufacturing and Supply Agreement. 

“Appendix” shall mean any Appendix as amended, dated, signed and renumbered (e.g. Appendix 1.1, 2.1, 3.1... and so forth) from time to
time. 
 “Approved Site(s)” shall mean the facilities and premises, as stated in Appendix 1, where manufacturing, analysis, packaging and
control of the Products under this Agreement shall take place. 
 “Background Technology” shall mean the full range of Carbogen’s
Intellectual Property Rights and factual knowledge in relation to [***] (i) existing on the Effective Date of this Agreement and/or (ii) licensed to, acquired or developed by Carbogen outside of this Agreement but during the term of this
Agreement, which Carbogen is free to dispose of. 
 “Business Day(s)” shall mean any working day(s) (with the exclusion of Saturday and
Sunday) on which banks are normally open in either Switzerland or Denmark, as may be applicable. 
 “Calendar Quarter” shall mean each
three (3) successive calendar months starting on 1 January, 1 April, 1 July or 1 October, respectively. 
 “Calendar
Year” shall mean 12 successive calendar months starting on 1 January. 
 “cGMP” shall mean Current Good Manufacturing Practice as
defined in the EC Guidelines to Good Manufacturing Practise, Volume IV, Part 1: Medicinal Products for Human and Veterinary Use. 

  
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 “Confidential Information” shall mean any proprietary information, samples, technical data,
trade secrets or know-how, including, but not limited to, research and development plans, products, services, lists of collaborators and corporate partners, markets, developments, inventions, processes,
formulas, technology, marketing, finances or other business information disclosed by either party (the “Discloser”) (either directly or indirectly in writing, orally or otherwise) to the other party (the “Recipient”). 

“Delivery” or “Deliver” shall mean the transfer of Product at the point where risk and responsibility is transferred from
Carbogen to Ascendis according to the agreed IncoTerms. 
 “Delivery Date” shall mean the date of Delivery of Product by Carbogen to
Ascendis or its designee as agreed in a Purchase Order. 
 “Effective Date” shall mean the date on which this Agreement becomes effective
in accordance with Article 15.1. 
 “EMA” shall mean the European Medicines Agency of the European Union. 

“[***]” shall mean [***]. 

“FDA” shall mean the Food and Drug Administration of the United States Department of Health and Human Services. 

“Final Release” shall mean the final release for delivery of Product by Ascendis or its designated representative. 

“Health Authorities” or “HA” shall mean any national or international health authority including but not limited to those of the
European Union, Japan, and the United States. 
 “Intellectual Property Rights” or “IPR” shall mean without limitation,
proprietary information, Know-how, patents, patent applications, formulae, trade-marks, trade-mark applications, trade-names, inventions, copyright, industrial designs etc. 

“Joint Steering Committee” or “JSC” shall have the meaning assigned to it in Article 5.1. 

“Know-how” shall mean any and all present and future data concerning Ascendis, Product, and any
derivatives hereof e.g., but not limited to production know-how, quality specifications, analytical data, data indicated in a DMF, patents, use-, packaging- and
improvement data, which data are possessed, performed and/or developed by either Ascendis or Carbogen and/or exchanged under any secrecy agreement between the Parties or any other agreement entered into between the Parties during the negotiations
prior to execution of this Agreement or during the currency of this Agreement, except for Background Technology. 
 “Materials” shall mean
starting materials & containers as listed in Appendix 8. 

  
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 “Other Services” shall mean work performed by Carbogen for Ascendis which does not relate
directly to the synthesis, manufacture, analysis, quality control, labelling, packaging and Delivery of the Product. Other Services are listed in Appendix 7. 

“PMDA” shall mean the Pharmaceuticals and Medical Devices Agency of Japan. 

“PPQ” shall mean the Process Performance Qualification of the manufacturing process of the Product “[***]”, as defined in Appendix
2, at the Approved Site(s). 
 “Product” shall mean Products as stated in Appendix 2. 

“Purchase Order” shall mean an order submitted by Ascendis according to Section 8.4 specifying Ascendis’ purchase order number,
required quantities of Product and requested date of delivery. 
 “Purchase Price” shall mean the price agreed to be paid by Ascendis to
Carbogen as set forth in Appendix 3. 
 “Quality Agreement” shall mean the agreement set out in Appendix 4 hereto. 

“Release Documentation” shall be the documentation which Carbogen shall provide to Ascendis following Carbogen’s internal release of the
Product. Such documentation shall at least contain a batch summary with certificates of conformance and list of deviations. Further details on the requirements for such documentation are specified in the Quality Agreement (Appendix 4). 

“Service Fee” shall mean the fee for the Services performed in connection with a Purchase Order but excluding the cost of materials and 3rd party costs. 
 “Services” shall mean the manufacture and Delivery of Product as set out
in this Agreement and the provision of Other Services as listed in Appendix 7. 
 “Shelf Life” shall mean the time span between the
manufacturing date and the expiry date of a batch, as approved at any given time. 
 “Specifications” shall mean the specifications of
Products, intermediates and key raw materials as listed in Appendix 5. 
 “Starting Period” shall mean the period of time from the
execution of this Agreement to [***]. 
 “Unused Service Fee” shall mean the difference between the Service Fee connected with a Purchase
Order and the costs of already performed Services in connection with that Purchase Order. 

  
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	3.	 SUBJECT MATTER OF THE AGREEMENT 

 

	 	3.1.	 This Agreement covers the post-PPQ manufacture and supply by Carbogen
of Product to Ascendis for commercial use worldwide as part of Ascendis’ [***] product. 

  

	 	3.2.	 Carbogen hereby undertakes, upon Ascendis’ written request, to synthesize, manufacture, analyse, quality
control, label, package and Deliver the Product to Ascendis, in accordance with the terms and conditions of this Agreement; and Ascendis will from time to time place Purchase Orders for Product according to forecasts as set forth in Article 6.
Operations shall take place in compliance with the Quality Agreement and at the premises listed in Appendix 1. 

  

	 	3.3.	 Carbogen also undertakes to provide Ascendis with Other Services as listed in Appendix 7 according to terms
agreed on a case-by-case basis in one or more separate agreements to be included in Appendix 7. 

 

	4.	 OBLIGATIONS OF THE PARTIES 

 

	 	4.1.	 Ascendis hereby undertakes to purchase the Product in the quantities ordered by Ascendis from time to time and
on the terms and conditions agreed upon hereunder, and Carbogen hereby undertakes to supply such Product to Ascendis pursuant to the terms of this Agreement. 

 

	 	4.2.	 Ascendis is neither bound to grant any kind of exclusivity to Carbogen under this Agreement nor to purchase
certain quantities of Product from Carbogen except as a consequence of having forecasted certain quantities in accordance with the provisions of Section 8.1. 

 

	 	4.3.	 In the performance of the Services, Carbogen shall, for all processes subject to cGMP, comply with all relevant
FDA, EMA and PMDA rules and regulations. 

  

	 	4.4.	 Carbogen and Ascendis shall discuss and liaise regarding the present status of the manufacturing and analysis
of Product on a continuous basis. Upon Ascendis’ request Carbogen shall inform Ascendis of the present status and the results obtained. 

  

	 	4.5.	 During and following the term of this Agreement, Carbogen shall make available any and all documentation
regarding the Product which in Ascendis’ reasonable assertion is required for (i) issue of patents and/or patent applications; (ii) regulatory filings to any regulatory body to which Ascendis may apply for registration of Product in
its final presentation. 

  

	 	4.6.	 Carbogen shall, up to [***], during the term of this Agreement grant [***] Ascendis [***] access (during normal
business hours and upon reasonable prior notice [***]) to visit Carbogen’s premises for routine audits of facilities, equipment, procedures, records and personnel. Ascendis shall also be allowed to perform
for-cause audits upon [***] notice, such reasonable causes to be defined in the Quality Agreement. 

  
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	 	4.7.	 Carbogen shall during the term of this Agreement allow inspectors from Health Authorities (possibly accompanied
by Ascendis staff), to perform the required inspections. Carbogen shall submit any observations relevant to the Manufacturing or Analytical Control of Products from such inspections to Ascendis without delay. 

 

	 	4.8.	 On the request of Ascendis, and upon prior notice [***] Carbogen shall allow [***] representatives from
Ascendis collaboration partners such as licensees, distributors (possibly accompanied by Ascendis staff), to inspect the Approved Site(s) upon prior signed Secrecy Agreement of such collaboration partners. Such inspections will be strictly related
to the manufacturing or analytical control of Products. If Products are implicated in regulatory inspection findings during audits initiated by authorities or other third parties, or if such findings are otherwise relevant for the manufacturing or
analytical control of Products Carbogen shall notify Ascendis without delay. 

  

	 	4.9.	 [***] 

  

	 	4.10.	 Carbogen shall not implement any change in [***] without having obtained Ascendis’ prior written approval,
unless such change is mandated by regulatory changes. In either case, Carbogen shall implement the changes at [***]. 

  

	 	4.11.	 Other significant post-approval changes in [***] shall be mutually agreed by the JSC and [***] the cost of
implementing the changes. 

  

	 	4.12.	 The Parties agree to keep each other promptly informed of any action by, or notification or other information,
which it receives (directly or indirectly) from any governmental or regulatory authority, which raises any concerns regarding the safety or efficacy of Product or any medicinal products containing Product. 

  
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	5.	 GOVERNANCE 

  

	 	5.1.	 The Parties shall form a JSC comprising of [***] members from each Party, including at least [***].

  

	 	5.2.	 The JSC shall meet at least [***] and shall discuss and evaluate the mutual collaboration and shall in good
faith attempt to resolve any disputes in connection with the Agreement. Each Party may call for an ad hoc teleconference as such Party deems necessary. As agreed between the Parties in each case, the meetings of the JSC may be carried out by
teleconference, video conference or face-to-face, as the case may be, provided however that the Parties endeavour to meet face to face at least [***].

  

	 	5.3.	 [***] 

  

	 	5.4.	 Written minutes of JSC meetings must be made alternately by each Party and must be circulated for comments no
later than [***] after each meeting. 

  

	6.	 COMMUNICATIONS 

 

	 	6.1.	 The Parties agree that electronic communications (email) are acceptable for exchanging forecasts, Purchase
Orders, order confirmations, agendas, meeting minutes and other information of an operational nature. Legal notices shall be delivered physically by courier. 

 

	 	6.2.	 The Parties agree to each appoint a primary Logistics contact person and a primary Quality Assurance contact
person. 

  
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	7.	 MATERIALS AND SUBCONTRACTING 

 

	 	7.1.	 Carbogen shall – [***] – be responsible for sourcing Materials as required from reputable third party
manufacturers. Carbogen shall notify Ascendis in writing once a manufacturer has been appointed and such manufacturer shall be an approved manufacturer of the relevant Material (as defined in Appendix 8). Carbogen shall provide Ascendis with all
details and information concerning the third party manufacturer as may be required by Ascendis to comply with Applicable Law and Regulations. Once a manufacturer has been appointed as an approved manufacturer of a specific Material, Carbogen shall
not appoint a replacement manufacturer or a second manufacturer of the same Material without Ascendis’ prior written consent, which consent shall not be unreasonably withheld or delayed. [***] Loss of Materials due to expiry caused by lowered
forecast or cancelled orders shall be at the risk of Ascendis. 

  

	 	7.2.	 Any performance of the Services by a third party manufacturer shall be subject to Ascendis’ prior written
approval. [***] shall be considered approved by Ascendis as of the Effective Date. 

  

	8.	 FORECAST AND PURCHASE ORDERS 

 

	 	8.1.	 Forecast: 

Ascendis shall provide Carbogen with a written rolling forecast showing Ascendis’ expected requirements for the Product “[***]”
([***]) to be Delivered under this Agreement during the following [***]. The forecast for [***] will be considered fully binding on the Parties, i.e. Ascendis commits to order and purchase the forecasted quantity and Carbogen commits to Deliver
such. The forecast for [***] is [***] binding [***] and the forecast for [***] shall be considered non-binding. The first such forecast shall be supplied [***]. The forecast shall be updated [***] no later
than [***]. 
  

	 	8.2.	 [***] of Intermediates: 

Based on the forecast for [***], Carbogen shall [***] of [***] according to [***] and plan for the timely manufacture of these intermediates in
due time. Carbogen shall in due time request for Ascendis to place Purchase Orders for required quantities of [***], such Purchase Orders to be issued by Ascendis within no more than [***] of having received the request. [***] To be clear: this
section only covers [***]; costs of unused materials are covered in chapter 15.4 c. 

  
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	 	8.3.	 [***] binding forecasts: 

Before having placed Purchase Orders, binding forecasts may [***], provided, however, that [***]. 

 

	 	8.4.	 Purchase Orders: 

Ascendis shall from time to time place Purchase Orders with Carbogen on the terms agreed herein. A Purchase Order shall [***]. For [***],
Purchase Orders must be placed in due time for at least the quantity bound through the forecasting procedure ([***]). Ascendis may also place Purchase Orders for quantities beyond the binding forecast, and Carbogen shall use [***] to Deliver such
additional quantities but shall not be obliged to do so unless Carbogen confirms the full Purchase Order. Ascendis shall on each Purchase Order specify the requested date of Delivery which shall be no earlier than [***] from submission of each
Purchase Order. [***] Carbogen shall confirm such Purchase Orders in writing no later than [***] upon receipt of said Purchase Orders [***]. 
  

	 	8.5.	 Cancellation of Purchase Orders 

In case Ascendis cancels Purchase Orders it shall pay [***]% of all costs for raw materials consumed or purchased for such Purchase Orders,
[***]% of the cost of already performed Services, and the following cancellation fees: 
  

	 	•	 	 [***]% of the Unused Service Fee for cancellation 3 [***]
before commencement of manufacture of [***] 

  

	 	•	 	 [***]% of the Unused Service Fee for cancellation <[***] and
3[***] before commencement 

  

	 	•	 	 [***]% of the Unused Service Fee for cancellation <[***] and
3[***] before commencement 

  

	 	•	 	 [***]% of the Unused Service Fee for cancellation <[***] before commencement 

 

	 	•	 	 [***]% of the Unused Service Fee for cancellation after commencement. 

  
 Page 10 of 33 

	9.	 BATCH SIZE AND CAPACITY 

 

	 	9.1.	 Linker [***] shall be manufactured and delivered in a batch size of [***]. The acceptable range and the
manufacturing batch sizes for intermediates shall be reflected in Appendix 6, as updated in writing from time to time upon mutual agreement. 

  

	 	9.2.	 On the Effective Date, Carbogen guarantees ability to Deliver [***] (subject to agreed forecasting procedure
and no force majeure events) using [***]. 

  

	 	9.3.	 On the Effective Date, Carbogen guarantees ability to deliver up to [***] (subject to agreed forecasting
procedure and no force majeure events), provided [***]. 

  

	 	9.4.	 The Parties agree to mutually discuss options to secure flexibility in the supply of Product and mitigate the
risk of shortages in case Ascendis’ actual needs turn out lower or higher than forecasted. 

  

	10.	 DELIVERY AND RELEASE 

 

	 	10.1.	 Carbogen shall Deliver Product ordered under Article 8 in the quantities agreed and under the common
understanding by the Parties that it is of the essence to Ascendis that Carbogen observes Delivery Dates and that Product Delivered under this Agreement is of the agreed quality and Specifications. 

 

	 	10.2.	 Carbogen bears the responsibility towards Ascendis that any required conditions for storage of the Product are
fulfilled until Delivery thereof to Ascendis or its designee. 

  

	 	10.3.	 Product shall be delivered to Ascendis or its designee [***] according to Incoterms 2010 in the Master Batch
Record. 

  

	 	10.4.	 Carbogen shall no later than [***] prior to the confirmed Delivery Date forward the Release Documentation for
Ascendis to review. Following receipt of the Release Documentation, Final Release shall be performed by Ascendis’ Qualified Person within [***], such Final Release not to be unreasonably withheld or delayed. Delivery is subject to Final
Release. 

  

	 	10.5.	 During the Starting Period, the time limit of [***] stated in Section 10.4 shall be [***].

  

	 	10.6.	 Any delay in delivery of the Product and/or Release Documentation shall be notified to Ascendis no later than
[***] after the delay has become apparent to Carbogen, including a description of the cause. Carbogen shall [***] solve the issues and shall confirm a new Delivery Date to Ascendis as soon as possible. 

 

	 	10.7.	 If Ascendis finds that the Release Documentation does not comply with the Specifications or with any other
requirement under this Agreement, Ascendis shall notify Carbogen in writing of Ascendis’ observations with respect to the non-compliance without undue delay after receipt of such documentation, provided
that failure by Ascendis to do so shall not imply any loss of rights or remedy for Ascendis under this Agreement or at law. 

  
 Page 11 of 33 

	 	10.8.	 Carbogen shall upon Ascendis’ written request store released Product for a period of [***]. Requests for
storage beyond the current dedicated storage capacity are contingent upon Ascendis giving Carbogen reasonable notice. [***] 

  

	11.	 PURCHASE PRICE AND PAYMENT TERMS 

 

	 	11.1.	 Ascendis will pay to Carbogen the Purchase Price for Product and Other Services. 

 

	 	11.2.	 The Purchase Price for Product is listed in Appendix 3. The Purchase Price for Other Services will be agreed in
separate agreements as detailed in Appendix 7. 

  

	 	11.3.	 The agreed Purchase Price for Product is based on [***] and [***]. It is agreed that the Purchase Price shall
be verified [***] and adjusted accordingly if [***]. 

  

	 	11.4.	 Carbogen’s price for the Services [***]. If Carbogen is obligated by law to charge any value added and/or
similar tax to Ascendis, Carbogen shall ensure that if such value-added and/or similar tax is applicable, that it is invoiced to Ascendis in accordance with applicable rules so as to allow Ascendis to reclaim such value-added and/or similar tax from
the appropriate government authority. Neither Party is responsible for taxes on the other Party’s income or the income of the other Party’s personnel or subcontractors. If Ascendis is required by government regulation to withhold taxes for
which Supplier is responsible, Ascendis will deduct such withholding tax from payment to Supplier and provide to Supplier a valid tax receipt in Carbogen’s name. If Carbogen is exempt from such withholding taxes as a result of a tax treaty or
other regime, Carbogen shall provide to Ascendis a valid tax treaty residency certificate or other tax exemption certificate at a minimum of [***] prior to payment being due. 

 

	 	11.5.	 For the avoidance of doubt, the price for the Services [***]. 

 

	 	11.6.	 Carbogen shall invoice Ascendis for [***] deliveries [***] or [***], whichever event comes first. Invoicing for
Other Services shall follow the agreements listed in Appendix 7. 

  

	 	11.7.	 Payments by Ascendis will be made in [***] after receipt of invoice by Ascendis. All late payments will,
without further notification, be charged with interest for late payment calculated on a daily basis from the due date until full payment at the rate of [***]. 

  
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	12.	 REGULATORY COMPLIANCE AND SUPPORT 

 

	 	12.1.	 Carbogen is obligated to support global regulatory requirements and requests. Health Authority Requirements are
in this context defined as direct legal requirements imposed on Ascendis where non-compliance results in loss of license to operate or financial penalties due to
non-compliance in the respective region. Health Authority Requests are defined as enquires from Health Authorities with relation to regulatory submissions (including but not limited to marketing authorization
applications, clinical trial applications, line extensions, variations and safety requests). 

  

	 	12.2.	 Carbogen is obligated to deliver any information/data needed to support both Health Authority Requirements and
Health Authority Requests. Data should be delivered to Ascendis according to respective Health Authority Controlled Terms as applicable and where possible in structured format (in a suitable file format). 

 

	 	12.3.	 Carbogen must make available any information/documentation/data required to support regulatory
requirements/requests no later than [***] following the first written enquiry from Ascendis. 

  

	 	12.4.	 Ascendis shall [***] Carbogen for regulatory support. [***] 

 

	13.	 NON-COMPLIANCE 

 

	 	13.1.	 If Ascendis finds that Product Delivered does not conform to the terms and conditions of this Agreement,
including, without limitation, the Specifications and/or Quality Agreement and/or cGMP, Ascendis shall no later than [***] after delivery notify Carbogen hereof in writing with Ascendis’ observations with respect to the non-compliance. For latent defects not detectable by inspection on supply (as defined in the Quality Agreement), Ascendis shall notify Carbogen no later than [***] after Delivery in writing. 

 

	 	13.2.	 Carbogen shall within [***] calculated from the day on which such written complaint has been received by
Carbogen, inform Ascendis whether Carbogen agrees or not to the complaint filed. If such response is not given within the above-mentioned [***] it is understood that Carbogen agrees to said complaint. 

 

	 	13.3.	 In the event of a dispute as to the acceptance of a batch of Product, the Parties agree to seek an amicable
settlement by way of discussions between quality assurance representatives from either Party. If the dispute is not resolved amicably within [***] from Ascendis’ written notice mentioned in Article 13.1, the issue may be referred to [***].

  

	 	13.4.	 If the Parties agree or it is otherwise concluded that Product delivered does not conform with this Agreement
and non-conformity is attributable to Carbogen’s proven failure, Carbogen shall on mutual agreement with Ascendis, [***]. If the defect was detected after shipment from Carbogen, Carbogen shall [***].

  
 Page 13 of 33 

	14.	 RECALL 

  

	 	14.1.	 [***] shall [***] whether and under what circumstances to require the recall of batches of Product. [***] In
the event that a recall of a batch from sale is necessary [***]. 

  

	15.	 TERM AND TERMINATION 

 

	 	15.1.	 This Agreement will come into effect on the date of last signing hereof and will continue in effect until five
(5) years following first commercial launch of Ascendis’ TransCon hGH pharmaceutical product (the “Initial Term”). 

  

	 	15.2.	 This Agreement will continue in effect after the end of the Initial Term unless and until terminated by either
Party according to the provisions for termination. 

  

	 	15.3.	 Notwithstanding any termination of this Agreement, the rights and duties of the Parties with respect to any
terms, which by their nature are intended to survive termination, shall survive and continue to be enforceable, including but not limited to Articles 2, 13, 14, 15, 16, 17, 18, 22. 

 

	 	15.4.	 This Agreement may be terminated: 

 

	 	a)	 By either Party upon written notice to take effect immediately in the event of: 

 

	 	i)	 An assignment by the other Party for the benefit of creditors; 

 

	 	ii)	 The admitted insolvency of the other Party; 

 

	 	iii)	 The institution of voluntary or involuntary proceedings by or against the other Party in bankruptcy,
insolvency, moratorium or for a receivership, or for a winding-up or for the dissolution or reorganization of the other Party; or 

 

	 	iv)	 The taking of any action by the other Party under an act for relief from creditors; 

 

	 	b)	 By either Party upon [***] written notice to the other Party in the event of a failure of such other Party to
perform or observe a material obligation imposed by this Agreement, unless such failure is cured, or the Parties have reached agreement on a plan to achieve a cure of such failure prior to the end of such [***] period. 

  
 Page 14 of 33 

	 	c)	 By Ascendis after the Initial Term with one (1) year’s written notice, provided, that Ascendis shall
[***] any unused Materials not already paid for under separate work orders, which Carbogen are unable to use for other purposes than the provision to Ascendis of Product. 

 

	 	d)	 By Carbogen after the Initial Term with four (4) years’ written notice, provided Carbogen actively
assists in a tech transfer to an alternate supplier [***]. 

  

	 	e)	 By mutual agreement of the Parties. 

 

	 	15.5.	 This Agreement may be terminated by Ascendis upon [***] notice in the event of a change of fifty percent (50%)
or more of the direct or indirect ownership of Carbogen, if such ownership goes to a third party which is materially involved in the treatment of growth related disorders in humans. Carbogen shall provide prompt written notice to Ascendis of any
such change. 

  

	 	15.6.	 Termination of this Agreement, for any reason, shall not release either Party from any liability which at said
time it has already incurred to the other Party, nor affect in any way the survival of any rights, duties or obligations of either Party which are stated elsewhere in this Agreement to survive said expiration or prior termination. Nothing in the
immediately preceding sentence shall affect, be construed or operate as a waiver of the right of the Party aggrieved by any breach of this Agreement to be compensated for any injury or damage resulting therefrom which is incurred before or after
such expiration or termination. 

  

	 	15.7.	 On the written request of Ascendis and at termination of this Agreement, Carbogen shall cease using any and all
tangible Know-how, inventions and technical improvements supplied or developed hereunder and shall forward such Know-how, inventions and technical improvements, copy and
original, to Ascendis together with Product manufactured. Carbogen is entitled to retain one (1) copy of such documents forwarded with respect to Know-how, inventions and technical improvements, raw
materials and Product manufactured, in order for Carbogen to comply with the cGMP regulations and may not be used for any other purpose. Copies so retained shall, subject to cGMP, be destroyed no earlier than [***] after delivery. Furthermore,
Carbogen may keep such copies that may have been generated by automatic back-up systems. 

  

	 	15.8.	 Upon termination Carbogen shall keep the original batch documentation for Products manufactured and/or packed
by Carbogen in accordance with the obligations laid down in Appendix 4. 

  

	 	15.9.	 Upon termination Carbogen shall [***] regarding the Products manufactured and/or packed by Carbogen and [***]
in relation to [***] of the Products in accordance with the obligations laid down in [***]. 

  
 Page 15 of 33 

	 	15.10.	 If the Agreement is terminated [***], [***] shall [***]. 

 

	 	15.11.	 Upon termination or expiry of this Agreement and upon the written request of Ascendis, Ascendis and Carbogen
will enter into a tech transfer agreement (“TTA”), under which Carbogen provides [***] to obtain continued supply of Product from an alternate supplier. The costs and expenses of such tech transfer shall be agreed upon in such TTA and
shall be borne [***]. 

  

	16.	 CONFIDENTIALITY 

 

	 	16.1.	 The Recipient will not, during or subsequent to the term of this Agreement, use Confidential Information for
any purpose whatsoever other than for the performance of this Agreement or disclose Confidential Information to any third party other than employees, affiliates, subcontractors or representatives who have a need to know in order to perform the
Services. The Recipient agrees that Confidential Information shall remain the sole property of the Discloser. The Recipient further agrees to take all reasonable precautions to prevent any unauthorized disclosure of Confidential Information.
Notwithstanding the above, the Recipients’ obligation under this Clause 14 relating to Confidential Information shall not apply to information which: 

  

	 	a)	 is known to the Recipient at the time of disclosure to the Recipient by the Discloser as evidenced by written
records of the Recipient, 

  

	 	b)	 has become publicly known and made generally available through no wrongful act of the Recipient,

  

	 	c)	 has been developed independently by or on behalf of the Recipient with no use of or reliance upon the
Discloser’s Confidential Information, 

  

	 	d)	 has been received by the Recipient without restriction on disclosure from a third party, or

  

	 	e)	 Recipient can establish that it is required by law, subpoena, judgement, order or other similar form of process
to disclose to a government, other public authority or third party, provided that Recipient immediately upon learning of such obligation, and prior to disclosure, if lawfully possible, notifies Discloser of such disclosure obligation and reasonably
cooperates with Discloser in limiting the scope of disclosure, if lawfully possible. 

  

	 	16.2.	 Upon the termination of this Agreement (irrespective of the reason therefore), or upon the Discloser’s
earlier request, the Recipient will deliver on request to the Discloser all of the Discloser’s Confidential Information, which is in the Recipient’s possession or control with the exception of such copies as provided under Clause 15.7.

  
 Page 16 of 33 

	 	16.3.	 The obligations of the Recipient under this Clause 16 shall remain in effect for a period of [***] after the
termination or expiry of this Agreement. 

  

	17.	 INTELLECTUAL PROPERTY RIGHTS 

 

	 	17.1.	 All data, information and other results arising from the performance of this Agreement by Carbogen, in any way
related to the Product and developed by Carbogen alone or in concert with Ascendis and/or any third party hereunder shall [***] (including, but not limited to, inventions (patentable or not), copyright and
Know-how). Any pertaining tangible material, whether original or copy, in writing, electronically generated, tape recorded or otherwise, shall be submitted to Ascendis [***] upon written request. [***]
Carbogen is not entitled to use Product for any other purpose than for the performance of its services under this Agreement. 

Notwithstanding above, [***]. This Agreement shall not grant or be construed as granting any rights by license or otherwise to [***]. 

Furthermore, [***], and [***], subject to [***]. 

Other than as set out specifically above. This Agreement will not transfer any rights to intellectual property in any way. 

 

	 	17.2.	 Intellectual Property Rights utilized by Carbogen for purposes of performing its obligations under this
Agreement shall be listed in Appendix 9 as updated by Carbogen from time to time. 

  

	 	17.3.	 The Purchase Price paid by Ascendis to Carbogen in accordance with this Agreement, shall include payment for
[***] all written, other tangible and all electronically generated material [***], including, but not limited to, copyright and designs. All such written or other material [***], and [***] shall be entitled to make all possible use of it, including,
but not limited to, to publish, to transfer the incorporeal rights, to edit, and in every way to change the contents and design of the said written or electronic material [***]. 

 

	 	17.4.	 Ascendis shall be (i) at liberty not to make use of the said written material; (ii) entitled to make
any use whatsoever of the said written material as deemed useful for any purpose by Ascendis; (iii) entitled to make changes and/or deletions of any kind in the said written material and/or to transfer and/or assign its rights to same. The
Parties hereto confirm that remuneration based on commercial sale of the said written material, according principles for such sales and copyrights to software are not relevant for this agreement. 

 

	 	17.5.	 Carbogen hereby specifically declares on its own behalf and on behalf of any of its employees that it [***].
Furthermore, Carbogen hereby declares that it [***]. Carbogen declares in this connection on its own behalf and on behalf of any of its employees that it is willing to sign any additional document necessary to [***]. Carbogen shall use its best
endeavours to have any third party [***]. 

  
 Page 17 of 33 

	 	17.6.	 Intellectual Property Rights owned by Ascendis or licensed to Ascendis are necessary for Carbogen to perform
its obligations hereunder and to obtain the benefit of its rights under this Agreement. Accordingly, Ascendis hereby grants to the extent necessary to Carbogen a [***] solely [***] and solely [***]. [***] the use of such Intellectual Property Rights
[***]. 

  
 Page 18 of 33 

	18.	 INSURANCE AND LIABILITY 

 

	 	18.1.	 [***] written request prove to have taken out, insurance in order to cover damages on Product while in the
custody of [***]. 

  

	 	18.2.	 [***] written request prove to have taken out, a civil liability insurance in order to cover liabilities
imposed on [***] under national legislation and/or EU directives/regulations (a) as a consequence of any and all obligations under this Agreement [***] (b) as a consequence of negligent acts and/or omissions by [***], including, without
limitation [***] other treatment of Product. 

  

	 	18.3.	 A Party (the “Indemnifying Party”) shall indemnify the other Party, its directors, officers and
employees, for any and all damages, costs, expenses and other liabilities, including reasonable attorney’s fees and court costs, incurred in connection with any claim, action or proceeding to the extent proven in a court of competent
jurisdiction to have arisen from the negligence or intentional misconduct of the Indemnifying Party or such breach by the Indemnifying Party of any of its obligations under this Agreement. 

 

	 	18.4.	 The Indemnifying Party shall be entitled, at its option, to control the defense and settlement of any claim for
which it is liable hereunder, provided that the Indemnifying Party shall act reasonably and in good faith with respect to all matters relating to the settlement or disposition of the claim as the disposition or settlement relates to the party
entitled to indemnification. The indemnified party shall reasonably cooperate in the investigation, defense and settlement of any claim for which indemnification is sought or provided hereunder and shall provide prompt notice of any such claim or
reasonably anticipated claim to the Indemnifying Party. 

  

	 	18.5.	 Neither Party shall be liable for any indirect, consequential losses and damages, punitive damages, anticipated
or lost profits, business interruption, incidental or special damages, loss of time, or other similar losses in connection with this Agreement whether arising under any legal theory of liability (including under any indemnification obligation)
regardless of whether such Party knew or should have known of the possibility of such damages. 

  

	 	18.6.	 In the event of [***], Carbogen’s liability towards Ascendis [***]. 

 

	 	18.7.	 In the event of [***], Carbogen’s liability towards Ascendis [***]. 

 

	 	18.8.	 In the event of [***] related to [***], Carbogen’s liability [***]. 

  
 Page 19 of 33 

	19.	 REPRESENTATIONS AND WARRANTIES 

 

	 	19.1.	 Carbogen hereby represents and warrants the following: 

 

	 	a)	 it has obtained (and will maintain throughout the existence of this Agreement) all necessary approvals,
licenses or registrations necessary or desirable for the performance of the Services, 

  

	 	b)	 it has the necessary experience to perform the Services, 

 

	 	c)	 the personnel that Carbogen causes to be applied in the performance of the Agreement shall be appropriately
qualified and experienced for the tasks that they are to perform, 

  

	 	d)	 any machinery and equipment that Carbogen provides or causes to be applied in the performance of the Agreement
shall be of an appropriate quality and, as required by normal practice shall be qualified and approved by the relevant body or organization, 

  

	 	e)	 the Services are conducted in compliance with the laws as applicable at its domicile or by the relevant
Purchase Order and relevant standards, such as but not limited to cGMP, 

  

	 	f)	 the Services are conducted in compliance with relevant FDA, EMA and PMDA rules and regulations,

  

	 	g)	 Carbogen is not debarred under the provisions of the Generic Drug Enforcement Act of 1992, 21 U.S.C. Sec.
335a(a) or any foreign equivalents, and 

  

	 	h)	 in the event that during the term of this Agreement Carbogen (i) [***], Carbogen agrees to immediately notify
Ascendis and shall immediately cease all activities relating to this Agreement. 

  

	 	i)	 Carbogen has no knowledge, as of the Effective Date, of [***]. 

 

	 	19.2.	 Ascendis represents and warrants to Carbogen that 

 

	 	a)	 Ascendis is the owner or licensee or otherwise has the right to use and provide to Carbogen all information
provided to Carbogen relating to Product, and 

  

	 	b)	 it has and shall maintain all federal, state and local licenses or registrations necessary for the storage,
supply and sale of the Product to third parties (i) each such license or registration is valid and in full force and effect, (ii) there is no pending or to its knowledge threatened, suspension, revocation or cancellation of any such
license or registration, and (iii) there is no basis for believing or reasonably expecting any such license or registration will not be renewable upon expiration. 

 

	20.	 ASSIGNABILITY AND SUB-CONTRACTING 

 

	 	20.1.	 Except as stated otherwise in this Agreement neither Party shall be entitled to assign or sub-contract its rights and/or obligations hereunder in whole or in part to any third party, including any affiliated companies unless having obtained the other Party’s prior written approval, provided,
however, that Ascendis is free to assign its rights and obligations, including (without limitation) to a third party acquiring, by purchase or license, rights to further develop or commercialize Ascendis’ [***] product, [***].

  
 Page 20 of 33 

	21.	 FORCE MAJEURE 

 

	 	21.1.	 Neither Party shall be liable for non-performance of any provisions of
this Agreement due to force majeure as defined below. 

  

	 	21.2.	 Force majeure shall include strikes, lockouts, other industrial disturbances, rebellions, epidemics,
landslides, earthquakes, fires, storms, floods, sinking, droughts, civil disturbances, explosions, act or decisions of duly constituted national government authorities or of courts of law, impossibility to obtain equipment, supplies, fuel or other
required materials, unexpected toxicity findings of Product, beyond the control of the Party pleading force majeure preventing this Party from performing its rights and obligations and not to be overcome by due diligence of such Party and which
could not reasonably have been foreseen at the time accepting the relevant order, provided neither Party shall have any obligation to settle a labour dispute in order to exercise due diligence. 

 

	 	21.3.	 The Parties agree that if either of them finds themselves wholly or partly unable to fulfil their respective
obligations under this Agreement by reasons of force majeure, the Party pleading force majeure will as soon as possible notify the other Party of its inability to perform, giving a detailed explanation of the occurrence which excuses performance.
Except from the payments of funds that are due and payable prior to any force majeure neither Party shall be required to make up for any performance that is prevented by force majeure. 

 

	 	21.4.	 However, if the force majeure persists for a period of more than [***], and the Party pleading force majeure
cannot present a remedial action plan acceptable to both Parties within the said [***], the non-failing Party shall be entitled to terminate this agreement with immediate written notice. 

 

	22.	 ARBITRATION AND LAW 

 

	 	22.1.	 In the event of any controversy or claim arising out of or relating to any provision of this Agreement or the
breach, termination or invalidity thereof, the Parties shall try to settle the problem amicably between themselves. Should they fail to agree, the matter in dispute shall be settled by arbitration in accordance with the Arbitration Rules of [***].
The award rendered shall be final and binding and enforceable by any court having jurisdiction. The arbitration court shall consist of [***] and shall have its seat in [***]. The language of the proceedings shall be English. The Institute shall
appoint [***] on request by a Party hereto. 

  
 Page 21 of 33 

	 	22.2.	 This Agreement shall be governed by and construed in accordance with [***] Law without regard to its conflict
of law rules. 

  

	23.	 MISCELLANEOUS 

 

	 	23.1.	 This Agreement and all Appendixes constitutes the entire agreement between the Parties concerning the subject
matter hereof and supersedes all written or oral prior agreements or understandings with respect thereto, except any secrecy agreements made by the Parties, which shall survive the obligations undertaken hereunder. No variation or modification of
the terms of this Agreement nor any change of any of the terms or provisions hereof shall be valid unless stated in an amendment to this Agreement. This notwithstanding, any Appendix associated with this Agreement shall be valid if signed by an
Authorised Representative of each party. 

  

	 	23.2.	 The headings contained in this Agreement are for convenience and reference purposes only and shall not affect
the meaning of the interpretation of this Agreement. 

  

	 	23.3.	 The provisions of this Agreement are separate and divisible, and the invalidity or unenforceability of any part
shall not affect the validity or enforceability of any remaining part or parts, all of which shall remain in full force and effect. However, the Parties agree to substitute any invalid or unenforceable provision by a valid and enforceable
arrangement, which achieves to the greatest extent possible the financial balance and mutual understanding already established between the Parties. 

  

	 	23.4.	 The Appendices to this Agreement shall form an integral part of the Agreement and shall be regarded as
incorporated into the Agreement in every respect. In case of inconsistency between the terms and conditions of the said Appendices and this Agreement, the latter shall prevail to the extent of such inconsistency, except that in quality related
matters, the Quality Agreement shall prevail. 

  

	 	23.5.	 All communication between the Parties and all notices made hereunder shall be made in the English language
unless public authorities may require any written communication to be made in any other language and if so the Party submitting to the other Party and/or suggesting such written communication shall upon request from the other Party provide a proper
translation hereof into English (certified by an authorised translator should the receiving party so require). 

  

	 	23.6.	 In the implementation of and performance under this Agreement, each Party shall comply with any and all
relevant and applicable laws. Such compliance shall be the sole responsibility of such Party requiring no supervision, direction, responsibility or liability on behalf of the other Party. 

  
 Page 22 of 33 

	 	23.7.	 Agreement shall be valid or binding upon the Parties hereto unless made in writing and duly executed on behalf
of each Party hereto. 

 (Signatures on next page) 

  
 Page 23 of 33 

 In witness thereof, the Parties hereto have caused this Agreement to be executed in duplicate by their duly
authorised representatives. 
  

					
	Hellerup, October 10th 2018	 		 	Bubendorf, ..... 26 October...... 2018
			
	Ascendis Pharma A/S	 		 	CARBOGEN AMCIS AG
			
	/s/ Michael Wolff Jensen	 		 	/s/ Dr. Thomas Hartmann
	Michael Wolff Jensen	 		 	Dr. Thomas Hartmann
	Senior Vice President	 		 	
			
		 		 	 Senior Head of Key Account Services

CARBOGEN AMCIS AG

			
	  
	 		 	/s/ S. Fritschi
		 		 	    S. Fritschi
		 		 	    Vice President Operations

  
 Page 24 of 33 

 APPENDIX 1 

Approved Manufacturing Sites 
 [***] 

  
 Page 25 of 33 

 APPENDIX 2 

Product 
 Article number: [***] 

Article name: [***] 
 Wherever amounts of [***] are mentioned
they refer to [***]. 
  

	 	•	 	 Materials not part of the Product but manufactured and delivered under this Agreement, [***]

  
 Page 26 of 33 

 APPENDIX 3 

Purchase Price 
  

	 	○ 	 Service Fee for manufacture of [***] 

 

	 	•	 	 Service Fee for manufacture of [***] 

The above Service Fees include [***]. 
 Estimated cost for
[***]: [***] 
 Other Service Fees: 
 [***] 

Other Services, as specified in APPENDIX 7, to be priced separately. 

[***] 
 After a transition period of at least [***] the parties
shall [***]. 
 If one of the first [***] batches is rejected due to [***], the parties shall mutually agree on how to share the cost of this defective
batch. 

  
 Page 27 of 33 

 APPENDIX 4 

Quality Agreement 
 At any time the
current version of the “Commercial Quality Agreement Supplement to Master Services Agreement” to the Master Services Agreement will apply. 

  
 Page 28 of 33 

 APPENDIX 5 

Specifications 
 [***] 

  
 Page 29 of 33 

 APPENDIX 6 

Batch Sizes 
 Batch sizes are in
accordance to [***]. 

  
 Page 30 of 33 

 APPENDIX 7 

Other Services 
  

	 	•	 	 Carbogen shall perform stability studies according to a stability program to be agreed and invoiced as separate
work orders. 

  

	 	•	 	 Carbogen shall be responsible for the preparation and qualification of relevant reference standards, such work to
be agreed and invoiced as separate work orders. 

  

	 	•	 	 Manufacture of [***] to be agreed and invoiced as separate work orders 

 

	 	•	 	 [***] to be agreed and invoiced as separate work orders 

 

	 	•	 	 [***] to be agreed and invoiced as separate work orders. 

Please note that this list is non conclusive. 

  
 Page 31 of 33 

 APPENDIX 8 

Materials 
 Key raw materials manufactured
at CARBOGEN AMCIS within separate work orders: 
 [***] 
 Key
raw materials requiring product specific supplier qualification for Product: 
 [***] 

Key raw materials without requirement of a product specific supplier qualification for Product (quality relevant raw materials) 

(Ascendis approval according to section 7.1 not required): 
 [***]

 Other Productn specific raw materials and Product containers 

(Ascendis approval according to section 7.1 not required): 
 [***]

  
 Page 32 of 33 

 APPENDIX 9 

List of applicable Intellectual Property Rights 

[***] 

  
 Page 33 of 33EX-4.13

 Exhibit 4.13 

[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such
excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed. 
 (1) FUJIFILM
DIOSYNTH BIOTECHNOLOGIES UK LIMITED 
 AND 

(2) ASCENDIS PHARMA A/S 

COMMERCIAL SUPPLY AGREEMENT 
  

 

 CONTENTS 
  

									
	 1.
	  	 Definitions and Interpretation
	  	 	1	 
	 2.
	  	 Appointment and Term
	  	 	7	 
	 3.
	  	 Program Management, Forecasting and Orders
	  	 	8	 
	 4.
	  	 capacity and expansion terms
	  	 	11	 
	 5.
	  	 Manufacture of Products
	  	 	12	 
	 6.
	  	 Conforming batches and Non-Conforming
Batches
	  	 	15	 
	 7.
	  	 Delivery, Title and Risk
	  	 	16	 
	 8.
	  	 Price and Payment
	  	 	17	 
	 9.
	  	 Liability
	  	 	19	 
	 10.
	  	 Insurance
	  	 	21	 
	 11.
	  	 Intellectual Property
	  	 	22	 
	 12.
	  	 Intellectual Property Indemnity
	  	 	22	 
	 13.
	  	 Confidentiality
	  	 	22	 
	 14.
	  	 Change
	  	 	25	 
	 15.
	  	 Termination and Consequences
	  	 	25	 
	 16.
	  	 Force Majeure
	  	 	28	 
	 17.
	  	 Dispute Resolution
	  	 	28	 
	 18.
	  	 Audit
	  	 	29	 
	 19.
	  	 Notices
	  	 	29	 
	 20.
	  	 Export Controls, Modern Slavery and Corruption
	  	 	30	 
	 21.
	  	 Assignment and Sub-Contracting
	  	 	31	 
	 22.
	  	 General
	  	 	31	 
	 23.
	  	 Governing Law
	  	 	32	 
		  	 Schedule 1
	  	Charges	  	 	33	 
		  	 Schedule 2
	  	Forecasting and Orders	  	 	35	 
		  	 Schedule 3
	  	Addresses for Notice	  	 	38	 
		  	 Schedule 4
	  	Customer Deliverables	  	 	39	 
		  	 Schedule 5
	  	Storage Agreement	  	 	40	 
	 	  	Signature Page of Commercial Supply Agreement	  	43	 

 Fujifilm Ascendis Commercial Supply Agreement 

 THIS AGREEMENT IS BETWEEN 
  

	(1)	 FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED incorporated and registered in England and Wales with
company number 05803359 whose registered office is at Belasis Avenue, Billingham, TS23 1LH, England (“Fujifilm”); and 

  

	(2)	 ASCENDIS PHARMA A/S incorporated and registered in Denmark with registration number 29918791 whose
registered office is at Tuborg Boulevard 12, DK-2900 Hellerup, Denmark (the “Customer”), 

each individually a “Party” and collectively “the Parties”. 

BACKGROUND 
  

	(A)	 Fujifilm is a biopharmaceutical contract development and manufacturing organization. The Customer wishes to
appoint Fujifilm to supply batches of certain of the Customer’s products for commercial use in the Territory. 

  

	(B)	 Fujifilm and the Customer have agreed to work together on the terms and conditions contained in this Agreement.

 AGREED TERMS 
  

	1.	 DEFINITIONS AND INTERPRETATION 

 

	1.1	 In this Agreement the following words have the following meanings unless inconsistent with the context:

  

			
	“Affiliate”	  	in respect of either party, any company from time to time directly or indirectly Controlling, Controlled by or under common Control with that party;
		
	“Application”	  	the Customer’s biologics license or new drug application and marketing authorization application;
		
	“Applicable Laws”	  	those UK, EU laws issued by the European Commission and US laws, regulations and binding guidance, in each case to the extent applicable to the Program, together with the laws, regulations and binding guidance of other countries
agreed to be added pursuant to clause 5.4;
		
	“Ascendis Material”	  	a consumable item used or intended for use in a Program, being one supplied [***] by Ascendis, including [***];
		
	“Background IP”	  	all Intellectual Property Rights controlled, owned or jointly owned by either Party (or a third party on its behalf) prior to the Effective Date or developed independently from the Program;
		
	“Batch”	  	a quantity of an Intermediate Product, the Product or [***] Reagent that is produced from a run of the applicable Process;

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	1	 	

			
		
	“Business Day”	  	a day other than a Saturday, Sunday or public holiday in England and/or the country in which the Customer’s head office is located;
		
	“Campaign”	  	a series of at least 2 Batches of the same Product, or Intermediate Batches used in the manufacture of the Product, purchased in sequence using the same manufacturing equipment ([***]);
		
	“Campaign Price”	  	has the meaning given to it in paragraph 1.8 of Schedule 1;
		
	“cGMP”	  	Current Good Manufacturing Practice as defined in (i) the Federal Register volume 66 No 186 and those sections applicable within the FDA Regulations 21 CFR Part 210, 211, 600, 601 and 610 and (ii) the rules governing
medicinal products in the European Union. Volume 4 – Guidelines for good manufacturing practices for medicinal products for human and veterinary use. Part II – Basic Requirements for Active Substances used as Starting Materials and ICHQ7
and (iii) any similar UK specific regulations potentially coming into force after 19 March 2019;
		
	“Change”	  	has the meaning given to it in clause 0;
		
	“Charges”	  	has the meaning set out in clause 8.1;
		
	“Commercially Reasonable Efforts”	  	with respect to the activities pursuant to a Program, the reasonable efforts and resources used by a reputable biopharmaceutical contract manufacturing organization for drug substances of similar nature, complexity and developmental
stage in the same or similar circumstances;
		
	“Confidential Information”	  	the fact and terms of this Agreement and all information (in whatever form) in respect of the business of each of the Parties and each of its Affiliates including any ideas; business methods; finance; prices, business, financial,
marketing or development plans; products or services, know-how or other matters connected with products or services manufactured and/or marketed; customer lists or details; computer systems and software; which
is (in each case) provided or obtained by one Party to or for the other;
		
	“Conforming Batch”	  	a Batch of Product which has been produced in accordance with cGMP and which meets the Product Specification and a Batch of Intermediate Product [***] which has been produced in accordance with cGMP and which meets the [***] Reagent
Specification or the Intermediate Product Specification, as applicable;

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	2	 	

			
		
	“Consumable”	  	a consumable item used or intended for use in a Program, being one supplied by Fujifilm, including [***];
		
	“Control”	  	 (a)   any power (whether directly or indirectly and whether by the ownership of
share capital, the possession of voting power, contract or otherwise) to appoint and/or remove all or such of the members of the board or other governing body of a body corporate as are able to cast the majority of the votes capable of being cast by
members of that board or body on all, or substantially all, matters, or otherwise to control or have the power to control the policies and affairs of that body corporate; or
  

(b)   the holding and/or possession of the beneficial interest in and/or the ability to exercise the
voting rights applicable to shares or other securities in any person (whether directly or indirectly) which confer in aggregate on the holders thereto 50% or more of the total voting rights exercisable at general meetings of that body corporate on
all, or substantially all, matters,
  
 and “Controlled” and
“Controlling” shall be construed accordingly;

		
	“Customer Deliverable”	  	the deliverables to be supplied by the Customer listed in Schedule 4;
		
	“Customer Foreground IP”	  	all Foreground IP that constitutes an improvement or modification which [***] to the Customer’s Background IP [***];
		
	“Dedicated Equipment”	  	Fujifilm equipment in the Facility that is dedicated to the Customer;
		
	“Deviation”	  	a cGMP deviation as detailed in the Quality Agreement;
		
	“Disposition”	  	the part of the Program during which (i) the Product or [***] or Intermediate Product is tested for compliance versus the Product Specification; (ii) all production instruction and analytical records relating to cGMP
manufacture of each Batch prepared by Fujifilm are reviewed; and (iii) a Fujifilm recommendation for Product release or reject is made; in each case as applicable;
		
	“Drug Product”	  	the final dosage form of product which contains Product in association with other active or inactive ingredients [***];

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	3	 	

			
		
	“Effective Date”	  	the date of signature by all Parties to this Agreement;
		
	“Facility”	  	any of Fujifilm’s manufacturing facilities in which a Program will be performed;
		
	“Force Majeure Event”	  	any event or circumstances outside the reasonable control of a Party affecting its ability to perform any of its obligations under this Agreement including act of God, fire, flood, severe weather, epidemic or pandemic, war,
revolution, acts of terrorism, riot or civil commotion, acts of government, trade embargo, labour disputes (excluding labour disputes involving the Party in question), interruption of utility service, restraints or delays affecting shipping or
carriers, (where proper precautions have been taken by the party suffering the event or circumstance) inability or delay in obtaining supplies of adequate or suitable materials, (where proper precautions have been taken by the party suffering the
event or circumstance) breakdown or failure in equipment or machinery, (where proper precautions have been taken by the party suffering the event or circumstance) cyber-attack, currency restrictions, and illness affecting a material number of the
Program team, but shall not include the failure of Drug Product in clinical trials or failure of Drug Product to gain, or loss of, regulatory approval;
		
	“Forecast Date”	  	has the meaning given to it in paragraph 2.1 of Schedule 2;
		
	“Foreground IP”	  	all Intellectual Property Rights that arise or are obtained or developed by or on behalf of either Party in the course of the performance of a Program;
		
	“Fujifilm Foreground IP”	  	all Foreground IP [***];
		
	“Half Year”	  	has the meaning given to it in paragraph 2.1 of Schedule 2;
		
	“Health Authorities”	  	shall mean any national or international health authority including but not limited to those of the European Union, and the United States;
		
	“Indemnify”	  	on demand to indemnify and keep indemnified, and hold harmless, the Party to be indemnified on an after tax basis;
		
	“Initial Term”	  	the period from the Effective Date until 31 December in the year in which the fifth anniversary of the Launch Date falls;

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	4	 	

			
		
	“Intellectual Property Right”	  	any current and future intellectual property rights and interests including patents, utility models, designs, design rights, copyright (including rights in software), decryption rights, database rights, trade marks, rights pursuant
to passing off, service marks, business and trade names, domain names, know-how, results, data, databases, formulations, compounds, rights in biological or chemical materials, rights under data exclusivity
laws, rights under unfair competition laws, topography rights, inventions, rights in confidential information (including technical and commercial trade secrets); supplementary protection certificates and image rights, and rights of a similar or
corresponding character in any part of the world, in each case whether registered or not and including any application for registration and renewals or extensions of such rights in any country in the world and whether subsisting now or in the
future;
		
	“Intermediate Batch”	  	a Batch of an Intermediate Product that is produced from a run of the [***] intermediate element of the Process;
		
	“Intermediate Products	  	[***] the recombinant human growth hormone (hGH) produced as part of [***];
		
	“[***]”	  	has the meaning given to such term in clause 5.8.4
		
	“Joint Steering Committee”	  	the committee formed and operated by the Parties, which shall act in resolving disagreements and disputes between the Parties, discuss and evaluate the mutual cooperation and in good faith negotiate and decide upon issues;
		
	“Key Assumptions”	  	the key assumptions set out in part 2 of Schedule 2;
		
	“KPI”	  	a key performance indicator agreed by the Joint Steering Committee pursuant to clause 3.2.7;
		
	“Launch Date”	  	the date the Drug Product is first made available by the Customer in any country for sale as an approved drug for the treatment of patients;
		
	“Liabilities”	  	any (i) liabilities whether in contract, tort (including negligence) or otherwise; (ii) losses, costs (including internal costs/overheads), damages, fines or expenses including reasonable legal fees; and (iii) claim,
demand, proceeding, action or cause of action; in each case howsoever arising. “Liability” shall be construed accordingly;
		
	“Materials”	  	has the meaning given to it in clause 7.1;
		
	“Maximum Annual Quantity”	  	as set out in Schedule 2;
		
	“Minimum Annual Quantity”	  	as set out in Schedule 2;
		
	“Non-Conforming Batch”	  	a Batch which has not been produced in accordance with cGMP and/or does not meet, as appropriate, the Product Specification or the [***] Specification or the Intermediate Product
Specification;

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	5	 	

			
		
	“Order”	  	has the meaning given to it in Schedule 2;
		
	“Pass Through Costs”	  	has the meaning given to it in Schedule 1;
		
	”PPQ”	  	Process Performance Qualification
		
	“Process”	  	the particular process used, or to be used, for manufacture of the Product or the [***] Reagent, as applicable;
		
	“Process Specification”	  	the Process specification which is a QA Document;
		
	“Product”	  	TransCon [***] human growth hormone (hGH);
		
	“Product Specification”	  	the Product specification which is documented in a QA Document;
		
	“Production Year”	  	a period of twelve (12) consecutive calendar months ending on 31st December, the first Production Year commencing [***];
		
	“Program”	  	the production, testing and Disposition (if applicable) of Batches including pre and post manufacturing activities (such as campaign set up and Facility change-over) to be performed under this Agreement;
		
	“Program Manager”	  	the Program manager appointed by each of Fujifilm and the Customer under clause 3.1;
		
	“Quality Agreement”	  	the single document agreed by the Parties which sets out the mutually agreed quality standards applicable for the cGMP manufacture of the Products, Intermediate Products, and [***] Reagent, including documentation requirements,
notification, sampling, testing, rejections, complaints handling, deviation handling, CAPAs, change control, reporting and recall mechanisms;
		
	“QA Documents”	  	the Quality Agreement and the documents produced and approved in accordance with the Quality Agreement;
		
	“Recall”	  	has the meaning given to it in clause 9.6;
		
	“Regulatory Authority”	  	the U.S. Food and Drug Administration, the European Medicines Agency, the Medicines & Healthcare products Regulatory Agency and any successor to any such entities;
		
	“Subcontracted Work”	  	work subcontracted by Fujifilm under clause 21.3;
		
	“Shelf Life”	  	the shelf life of Materials, detailed in the Storage Agreement;

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	6	 	

			
		
	“Storage Agreement”	  	the terms and conditions for storage of [***] Reagent, the Intermediate Products (to the extent [***]) and Product, set out in Schedule 5;
		
	“Tax”	  	value added tax, sales tax or any other similar type of turnover tax;
		
	“Territory”	  	worldwide
		
	“[***] Reagent”	  	the [***], known as [***];
		
	“[***] Specification”	  	the Process specification for the [***] Reagent, which is documented in a QA Document; and
		
	“Year”	  	each period of 12 (twelve) consecutive months commencing on the Effective Date or an anniversary of the Effective Date, the final last Year commencing on the last anniversary of the Effective Date and ending on the date of
termination or expiry.

  

	1.2	 In this Agreement (except where the context otherwise requires) any words following the terms
“including”, “include”, “for example” or any similar expression are by way of illustration and emphasis only and shall not limit the generality or extent of any other words or expressions.

  

	1.3	 Insofar as this Agreement obliges either Party to this Agreement to negotiate, take action or to do something,
that Party shall conduct such negotiations, take such action or do such thing in good faith and, in the case of Fujifilm, using Commercially Reasonable Efforts to achieve the result contemplated in this Agreement. There shall be a general obligation
on the Parties to act in good faith in relation to the matters contemplated in this Agreement. 

  

	1.4	 In the case of conflict or ambiguity between terms of the main body of this Agreement or any Schedule to this
Agreement the main body of the Agreement shall prevail. In the case of conflict or ambiguity between the terms of this Agreement and the terms of the QA Documents, the terms of the QA Documents shall prevail solely in relation to cGMP quality
matters subject to clause 9.9. 

  

	1.5	 Where a defined term is used in clause 9 (Liability) it shall retain its meaning even when the entire word that
is a defined term is in capitals. 

  

	2.	 APPOINTMENT AND TERM 

 

	2.1	 This Agreement establishes the general terms and conditions applicable to Fujifilm’s post-PPQ supply of the Products to the Customer. All Orders made by the Customer to Fujifilm for Product during the term of this Agreement are subject exclusively to the terms and conditions of this Agreement and
any standard terms of the Customer referenced in an Order for Products shall not apply. 

  

	2.2	 This Agreement shall come into force on the Effective Date and shall, unless terminated earlier by a Party in
accordance with clause 15, continue for the Initial Term and thereafter unless and until terminated in accordance with clauses 2.3, 2.4 or 2.5. 

  

	2.3	 The Customer may terminate this Agreement by giving no less than 2 (two) years’ prior written notice to
Fujifilm, such notice to be served at the earliest at the end of the last day of the Initial Term. For example, the earliest termination can occur 

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	7	 	

	 	
is the seventh anniversary of the Launch Date. The Customer shall, in its sole discretion, either accept delivery of binding Orders and other minimum purchase commitments or shall pay to Fujifilm
the price for all undelivered binding Orders and other minimum purchase commitments detailed in this Agreement, including those Orders and commitments that extend beyond the date of termination. 

 

	2.4	 The Customer may terminate this Agreement (and related Orders) in respect of the Intermediate Products (but not
in respect of the Product) by giving no less than 2 (two) years’ prior written notice, such notice to be served at the earliest at the end of the last day of first year following the Launch Date. For example, the earliest termination can take
effect is the third anniversary of the Launch Date. The Customer shall in its sole discretion either accept delivery of binding Orders and other minimum purchase commitments or shall pay to Fujifilm the price for all undelivered binding Orders and
other minimum purchase commitments detailed in this Agreement, including those Orders and commitments that extend beyond the date of termination. 

  

	2.5	 Fujifilm may terminate this Agreement (and all Orders made under it) by giving no less than 5 (five)
years’ prior written notice to the Customer, such notice to be served at the earliest at the end of the last day of the Initial Term. For example, the earliest termination can take effect is the tenth anniversary of the Launch Date.

  

	2.6	 This Agreement does not supersede the agreement dated 24th
April 2015 between the Parties for the supply of product development services in relation to the Product (the “Development Agreement”). The Development Agreement shall continue to apply in respect of
pre-commercial manufacture of the Product, including the batches manufactured as part of the PPQ. 

  

	3.	 PROGRAM MANAGEMENT, FORECASTING AND ORDERS 

 

	3.1	 Within [***] of the Effective Date each Party will appoint a Program Manager to oversee and manage the
execution of its obligations under this Agreement. The Program Managers shall each be the primary contact for the other Party in relation to this Agreement and will be responsible for managing any Changes. The Program Managers’ responsibilities
shall include being the—or appointing a—primary logistics contact for communications regarding forecasts, orders, delivery and shipping. If either Party changes its appointed Program Manager it will promptly notify the other in writing.

  

	3.2	 Joint Steering Committee 

 

	 	3.2.1	 Composition. A Joint Steering Committee shall be established consisting of representatives from each
Party with the requisite experience and sufficient seniority to enable them to make decisions on behalf of the Parties. The Parties shall agree the number of representatives, provided an equal number of representatives of Fujifilm and the Customer
must be appointed. Each Party will designate its representative(s) to the Joint Steering Committee within [***] of the Effective Date. 

  

	 	3.2.2	 Purposes. The Joint Steering Committee shall have the responsibility to (i) oversee planning for
the Program; (ii) oversee the Parties’ performance under this Agreement; (iii) review matters such as the appropriate [***] of the Intermediate Product and [***] Reagent; (iv) consider qualified
back-up manufacturing and such other matters as they deem appropriate to protect against the risk of interruption of supply, whether due to the occurrence of a Force Majeure Event or otherwise;
(v) consider opportunities for mutual cooperation. [***] 

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	8	 	

	 	3.2.3	 Substitutions. Each Party may substitute one or more of its representatives, in its sole discretion,
effective upon written notice to the other Party of such change, provided that any such substitute shall have the requisite experience and seniority, together with such Party’s other representatives on the Joint Steering Committee, to make
decisions on behalf of such Party. 

  

	 	3.2.4	 Meetings. [***] shall be responsible for organizing and chairing the Joint Steering Committee meetings.
The Joint Steering Committee shall meet not less than [***] on such dates and at such times as agreed to by the Parties. It is expected that the meetings shall be held by telephone or video conference, provided that at least [***] the Joint Steering
Committee meets face-to-face, at a mutually agreed location. Either Party may call for a meeting (by telephone or video conference) of the Joint Steering Committee at
any other time upon the service of [***] written notice, such notice to indicate the primary purpose of the additional meeting. Each Party may permit visitors, including its employees or agents, who are not members of the Joint Steering Committee to
meetings of the Joint Steering Committee, as the Parties mutually agree in writing prior to such meetings; provided, however, that the Party that permits such visitors to attend any meeting of the Joint Steering Committee shall ensure that they
agree in writing or otherwise to be bound by confidentiality obligations at least as protective as the provisions of clause 13 prior to attending such meeting. Each Party shall bear the cost of its attendance, including travel and hotel costs and
other expenses incurred by its representatives. 

  

	 	3.2.5	 Operational update for first Campaign. At least [***] prior to the manufacture of the first Batch of the
first Campaign, the Joint Steering Committee will meet to agree on operational details of the Process, including the taking and analysis of in-process samples. 

 

	 	3.2.6	 Post-approval Changes. Any significant post-approval changes requested by either Party will be discussed
and agreed by the Joint Steering Committee, except where they are required by a change in Applicable Law in which case clauses 14.2 and 14.3 shall apply. Any other significant post-approval change shall be adopted as follows: 

 

	 	(a)	 either Party may notify the other of a post-approval change that it, acting reasonably, considers to be
significant. If the other Party disagrees that the proposed change is significant, the Joint Steering Committee shall review and determine whether it is prepared to review the change or require it to be dealt with by the regular change process in
clause 0; 

  

	 	(b)	 if the Joint Steering Committee agrees to review a significant change, the Party requesting the change shall
submit a change proposal detailing the change, the costs, the benefits and other relevant factors to each of the members of the Joint Steering Committee at least [***] prior to the meeting at which the change is to be discussed;

  

	 	(c)	 the Joint Steering Committee shall review and discuss the proposed change and agree the key commercial terms of
the change, including price, investment, timings and dependencies on the Parties. This agreement shall be recorded in the minutes of the meeting; 

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	9	 	

	 	(d)	 it may require more than one meeting of the Joint Steering Committee to conclude discussions on the change and
the Parties shall agree in each meeting what the respective Party’s commitments are prior to the next meeting; 

  

	 	(e)	 once the principles of a significant change have been agreed by the Joint Steering Committee the Parties shall
conclude the change using the processes determined in clause 0 (save that the Parties agree to skip any stages that have in effect been covered by the Joint Steering Committee’s review of the proposed changes); and 

 

	 	(f)	 any change that is not deemed a significant change by the Parties shall be managed in accordance with clause 0.

  

	 	3.2.7	 Performance Review. 

 

	 	(a)	 The Joint Steering Committee shall agree [***] to monitor and measure Fujifilm’s and Customer’s
performance under this Agreement. 

  

	 	(b)	 [***], each Party shall be responsible for recording its performance [***]. 

 

	 	(c)	 The Joint Steering Committee shall at each Joint Steering Committee meeting review each Party’s
performance [***]. If a Party fails to meet [***], then the Joint Steering Committee shall review the reasons why the failure(s) arose and shall agree what measures, if any, it should recommend that the Party should adopt to [***].

  

	 	3.2.8	 Minutes. Within [***] following each Joint Steering Committee meeting, a representative of the chairing
Party shall prepare and provide to each Party a copy of the minutes of such meeting which shall set forth, in reasonably specific detail, any approval, determination or other action agreed to by the Joint Steering Committee, provided that such
minutes are reasonably acceptable to both Parties. 

  

	 	3.2.9	 Dispute Resolution. Any disputes or disagreements arising in the Joint Steering Committee that cannot be
resolved by its members within [***] of having been brought to the Joint Steering Committee, shall be referred to the dispute escalation mechanism in clause 17. 

 

	 	3.2.10	 Fujifilm Independence. The Parties acknowledge and agree that Fujifilm shall have the right to make day-to-day operation decisions regarding the implementation and conduct of the Program in accordance with this Agreement. For the avoidance of doubt, (i) nothing
contained in this clause 3.2 nor any decisions made by the Joint Steering Committee, shall relieve either Party of its obligations under this Agreement, and (ii) the Joint Steering Committee shall not have the authority to amend this Agreement
or waive any breach hereof. 

  

	3.3	 Product, [***] Reagent and Intermediate Products [***] will be forecast, and Product and [***] Reagent and
Intermediate Product [***] will be ordered, in accordance with Schedule 2. 

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	10	 	

	4.	 CAPACITY AND EXPANSION TERMS 

 

	4.1	 Initial Reservation 

Fujifilm reserves sufficient capacity at the Facility to manufacture for the Customer at least [***] of the Product [***]. Fujifilm
acknowledges that this includes [***]. [***] [***]. 
  

	4.2	 [***] 

  

	 	4.2.1	 [***]. 

  

	 	4.2.2	 [***]. 

  

	 	4.2.3	 [***] 

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	11	 	

	5.	 MANUFACTURE OF PRODUCTS 

 

	5.1	 Fujifilm shall produce each Batch in accordance with: 

 

	 	5.1.1	 the terms of this Agreement; 

 

	 	5.1.2	 Applicable Laws; 

  

	 	5.1.3	 cGMP and the applicable Quality Agreement; 

 

	 	5.1.4	 using Commercially Reasonable Efforts; 

 

	 	5.1.5	 in accordance with the applicable Process Specification; and 

 

	 	5.1.6	 such that the Product, Intermediate Product ([***]) and [***] Reagent meets the applicable specifications.

  

	5.2	 The Customer shall: 

 

	 	5.2.1	 promptly provide the Customer Deliverables at the times set out in Schedule 2; 

 

	 	5.2.2	 meet all its obligations and responsibilities under this Agreement and the applicable Quality Agreement (either
that for the Product and related Intermediate Products, or for the [***] Reagent); 

  

	 	5.2.3	 comply with Applicable Laws; and 

 

	 	5.2.4	 promptly provide all assistance, information, and advice and do all acts which Fujifilm may reasonably request
to enable Fujifilm to comply with its obligations and responsibilities under this Agreement and the applicable Quality Agreement (either that for the Product and related Intermediate Products, or for the [***] Reagent). 

 

	5.3	 Fujifilm’s delivery of Programs and each Batch depends upon Customer’s compliance with clause 5.2.
Fujifilm will not be in breach of any obligation under this Agreement (including to deliver an Order and/or the Minimum Annual Quantity) if failure to meet that obligation is caused by Customer’s breach of or delay in performance of any
obligations under clause 5.2 and Customer will still be obligated to pay for the affected Order(s) and/or the Minimum Annual Quantit(ies) (as applicable). 

  

	5.4	 [***] 

[***] 
  

	5.5	 Quality Agreement 

 

	 	5.5.1	 The Parties have previously executed the Quality Agreement (Current version 3.00 dated 04 May 2018) in respect
of the Product, the related Intermediate Products and the [***] Reagent. 

  

	 	5.5.2	 The Customer acknowledges that Fujifilm shall not commence any activity under this Agreement until the
applicable Quality Agreement is executed by both Parties. 

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	12	 	

	5.6	 Regulatory Assistance  

 

	 	5.6.1	 The Customer shall provide Fujifilm with a copy of relevant parts of the Customer’s Chemistry,
Manufacturing and Controls section of any submission to a Regulatory Authority supporting an Application made by the Customer’s for the applicable Drug Product (whether the biologics license application or marketing authorisation application),
the [***] Reagent or the applicable Process, relevant parts being any part relating to Fujifilm’s manufacture of the Product (“CMC Section”) and any change thereto with enough time for Fujifilm to review and comment on the same
before submission to such Regulatory Authority, provided, however, that Fujifilm shall use Commercially Reasonable Efforts to perform its review and that such review by Fujifilm shall not be unreasonably withheld. The Customer shall not submit a CMC
Section without Fujifilm’s written approval in relation to any information regarding, or impacting, Fujifilm including any information regarding the Process, equipment, controls and analytics or any information provided to the Customer by
Fujifilm related to or in accordance with the applicable Quality Agreement. If the documents or support required from Fujifilm pursuant to this clause 5.6.1 relate [***], then Fujifilm may [***]. 

 

	 	5.6.2	 After the completion of the PPQ the Parties shall agree on the level of continuous process verification to be
applied by Fujifilm (which may be itself subject to an agreement change). If the Customer requires any support in relation to regulatory documentation regarding continuous process verification over and above the level agreed, then Fujifilm may agree
to provide that assistance [***]. 

  

	 	5.6.3	 Fujifilm will provide one electronic (PDF) copy of any documents which may be reasonably required by the
Customer in support of its Application. If the Customer requires copies of the laboratory notebooks, provision of these will be subject to discussion and agreement by the Parties and agreement of [***]. 

 

	 	5.6.4	 The Customer shall have the right and responsibility for determining regulatory strategy, decisions and actions
relating to the Product and/or Drug Product (including any BLA) and/or [***] Reagent subject to clause 5.6.5 and provided that Fujifilm shall have the right and responsibility for determining regulatory strategy, decisions and actions to the extent
relating to: 

  

	 	(a)	 the Facility (including in particular utilities and equipment); 

 

	 	(b)	 Fujifilm’s quality systems, policies and internal procedures; 

 

	 	(c)	 any requirement imposed on Fujifilm by a Regulatory Authority; or 

 

	 	(d)	 any other commitments made by Fujifilm prior to the Effective Date, 

(each a “Fujifilm Regulatory Responsibility”). 
  

	 	5.6.5	 Fujifilm is obligated to support regulatory requirements and requests [***] Health Authority Requirements are
in this context defined as direct legal requirements imposed on Customer in the respective region where non-compliance results in loss of license to operate or financial penalties due to non-compliance. Health Authority Requests are defined as enquiries from Health Authorities in the respective region with relation to regulatory submissions (including but not limited to marketing authorization
applications, clinical trial applications, line extensions, variations and safety requests). 

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	13	 	

	 	5.6.6	 Fujifilm shall use its Commercially Reasonable Efforts to deliver any information/data required to support both
Health Authority Requirements and Health Authority requests. Data should be delivered to Customer according to respective Health Authority controlled terms as applicable and where possible in structured format (in a suitable file format).

  

	 	5.6.7	 Fujifilm must make available any information/documentation/data required to support regulatory
requirements/requests as soon as reasonably possible and no later than [***] following the first written enquiry from Customer. 

  

	 	5.6.8	 The Customer acknowledges that Fujifilm’s Quality Assurance team reserves the right to Disposition Product
and [***] Reagent to the Customer in accordance with the applicable Quality Agreement. 

  

	 	5.6.9	 The Customer shall not make any change to its regulatory filings, including any Application, which may have an
impact on any Fujifilm Regulatory Responsibility or Fujifilm’s performance of its obligations under this Agreement without prior written agreement with Fujifilm in accordance with clause 0. 

 

	5.7	 Storage 

  

	 	5.7.1	 Where Product, Intermediate Product and [***] Reagent is specified in clause 5.8 as being stored by Fujifilm in
accordance with the terms of the Storage Agreement: 

  

	 	(a)	 the storage will be subject to a separate Product-specific schedule that will be deemed to form part of the
Storage Agreement in Schedule 5; 

  

	 	(b)	 the Parties may vary the operational content of the Storage Agreement in accordance with clause 0.

  

	 	(c)	 the Customer shall [***] in respect of all items stored by Fujifilm. 

 

	5.8	 Agreed inventory management principles 

Fujifilm agrees that it shall adopt the following inventory management principles in supporting the Program. 

 

	 	5.8.1	 Fujifilm will purchase long-lead time Consumables on receipt of the Order and other Consumables in good time
for scheduled production. Consumables are charged to the Customer in accordance with Schedule 1. 

  

	 	5.8.2	 Fujifilm will store the [***] in accordance with the Storage Agreement. Fujifilm will [***]. The Customer will
[***] in line with [***]. Fujifilm is not responsible for [***], but must [***]. If Fujifilm [***] (i) the Customer agrees that [***] (ii) to the extent that [***], Fujifilm agrees that it will [***]. 

 

	 	5.8.3	 Fujifilm will store Intermediate Product in the ordinary course of a Campaign [***]. 

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	14	 	

	 	5.8.4	 At the Customer’s request (by placement of Orders) [***] Fujifilm will manufacture [***] of each of [***]
and intermediate recombinant hGH ([***]) and store [***] in accordance with the Storage Agreement. Orders for [***] must be issued at the same time as Orders for Product and [***]. Fujifilm shall replace [***] that is, through Fujifilm’s wilful
misconduct, irrevocably harmed. 

  

	 	5.8.5	 If the Customer requests, Fujifilm shall store up to [***] of Product in accordance with the Storage Agreement.

  

	 	5.8.6	 Fujifilm shall manufacture [***] Reagent at [***] scale and shall store no less than [***] at any time, in
accordance with the Storage Agreement. On each occasion Fujifilm believes the forecast volumes require it, Fujifilm shall notify the Customer that Fujifilm must produce [***] of [***] Reagent. The Customer shall without undue delay issue an order
for the volume identified by Fujifilm. 

  

	5.9	 Freezer capacity 

 

	 	5.9.1	 If the frequency of Campaigns increases from that anticipated at the Effective Date, or the number of Batches
within Campaigns is increased, such that the volume of Batches of Product ([***]) and any Batches of Intermediate Product produced in accordance with clause 5.8.4 increases such that Fujifilm requires additional freezer space to accommodate the
volumes, [***]. 

  

	6.	 CONFORMING BATCHES AND NON-CONFORMING BATCHES

  

	6.1	 Each Batch will be determined to be a Conforming Batch or a
Non-Conforming Batch. 

  

	6.2	 If during manufacturing Fujifilm discovers any significant Deviation it will inform the Customer in accordance
with the reporting requirements set out in the Quality Agreement. The Customer agrees that only Deviations which are determined to affect, as applicable, Product quality, Intermediate Product quality, or [***] Reagent quality will cause a Batch to
be classified as a Non-Conforming Batch. 

  

	6.3	 In respect of Conforming Batches, Fujifilm will complete Disposition, issue a certificate of analysis and a
cGMP compliant statement. The provisions of clauses 6.4 to 6.6 shall apply to Non-Conforming Batches only. 

  

	6.4	 If a Batch is a Non-Conforming Batch (including where the non-conformance is demonstrated by the Customer after delivery) and the cause of that Batch being a Non-Conforming Batch is not a failure by Fujifilm to comply with
clause 5.1 then [***]. Any further work in relation to the Non-Conforming Batch (such as analysis of the Batch) or manufacture of a replacement Batch shall [***]. 

 

	6.5	 If a Batch is a Non-Conforming Batch (including where the non-conformance is identified by the Customer after delivery) and the cause of the Batch being a Non-Conforming Batch is a failure by Fujifilm to comply with clause 5.1
then Fujifilm shall [***]. In these circumstances the Customer shall [***]. If the non-conformity is discovered after shipment to the Customer, Fujifilm shall [***]. In addition, in the circumstances described
in this clause 6.5 Fujifilm shall [***]: 

  

	 	6.5.1	 [***]; or 

  

	 	6.5.2	 if the cause of the Non-Conforming Batch is caused by [***].

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	15	 	

	6.6	 If the Customer requests delivery of a Non-Conforming Batch it must
make such request to Fujifilm in writing within [***] of being informed that the Batch is a Non-Conforming Batch. Fujifilm agrees to deliver a Non-Conforming Batch to
the Customer on the express condition that [***]. 

  

	6.7	 Any dispute regarding conformity shall be resolved in accordance with the dispute process set out in the
Quality Agreement, which process shall be final. 

  

	7.	 DELIVERY, TITLE AND RISK 

 

	7.1	 Delivery by Fujifilm to the Customer of the Products and any other output from the Program which is deliverable
to the Customer under this Agreement (including [***]), any Process-Specific Equipment and/or Process-Specific Consumables and return of any Customer Deliverables (“Materials”) will be made [***] (Incoterms 2010) and clauses 7.2 to
7.7 shall apply to such Materials. Fujifilm shall package the relevant Material ready for shipment in accordance with the Customer’s reasonable instructions. 

 

	7.2	 Delivery of Materials will be deemed to be completed: 

 

	 	7.2.1	 in respect of Product, [***]; 

 

	 	7.2.2	 in respect of [***]; 

 

	 	7.2.3	 in respect of [***] Reagent, [***]; 

 

	 	7.2.4	 in respect of any Materials other than those described above, [***], 

in each case the point of delivery being as set out in [***] (Incoterms 2010) (the “Facility”). 

 

	7.3	 If the Customer fails to collect Materials that have been deemed to be delivered under clause 7.2 Fujifilm
shall notify Customer that the Materials are available for collection. If Customer does not collect the Materials within [***] of such notice, Fujifilm may, [***]. 

 

	7.4	 Risk in the Material shall pass to the Customer on the earlier of (i) completion of actual delivery or
(ii) the date stated in clause 7.2 that the applicable type of Material is deemed delivered. 

  

	7.5	 The Customer shall make and pay for all logistics arrangements to collect the Materials in accordance with
clause 7.1 and to deliver the supplied items pursuant to clause 7.8. 

  

	7.6	 If Fujifilm reasonably believes that the scheduled delivery date for a consignment will be delayed beyond the
previously agreed dates, it shall promptly advise the Customer in writing of the reason for the delay, the Materials affected and the new estimated delivery date. Fujifilm shall use Commercially Reasonably Efforts to make the Materials available for
delivery with as short a delay as reasonably possible. 

  

	7.7	 Title to the Product shall pass to the Customer [***]. 

 

	7.8	 Delivery of any materials which the Customer is required to supply to Fujifilm pursuant to this Agreement shall
be delivered to Fujifilm [***] (Incoterms 2010). 

  

	7.9	 Risk and title in [***]. [***] Intermediate Products shall not be delivered to the Customer, but rather used in
the Campaign to manufacture Product. 

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	16	 	

	7.10	 Risk and title in [***] shall pass upon [***]. 

 

	7.11	 Risk and title in [***] Reagent shall transfer to Customer once the Batch has completed Disposition, however it
will not be delivered to the Customer but instead will be used in Campaigns to manufacture Product. 

  

	7.12	 The Customer shall notify Fujifilm within [***] of the date of delivery of Product of any non-conformity of the Product, unless it is a latent defect in which case the Customer shall notify Fujifilm within [***] of the date the latent defect was discovered. If
non-conformity (including latent defect) is not notified within [***] of the date of Disposition, the Customer may not (notwithstanding the cause of the non-conformity)
make any claim against Fujifilm in respect of the alleged Non-Conforming Batch. 

  

	8.	 PRICE AND PAYMENT 

 

	8.1	 The Customer shall pay to Fujifilm for each Program: 

 

	 	8.1.1	 the Batch Price for each Batch; and 

 

	 	8.1.2	 [***], 

in each case as set out in Schedule 1 (together the “Charges”). 

 

	8.2	 [***] 

  

	 	8.2.1	 Within [***] following the end of each Production Year Fujifilm shall notify the Customer of the number of
Batches of Product delivered during that Production Year. 

  

	 	8.2.2	 If the number of Batches of Product ordered for Delivery within that Production Year is less than the greater
of (i) the Minimum Annual Quantity for that Production Year and (ii) the forecast for the Production Year (as determined in accordance with paragraph 2 of Schedule 2) the Customer shall, subject to clause 8.3, [***]. The Customer shall not
be required to [***], except to the extent that [***]. 

  

	8.3	 If the Customer reasonably believes that the shortfall in Batches of Product arises directly from
Fujifilm’s failure to make the required capacity available for the manufacture of such Batches, or from Fujifilm’s delay in delivery or by reason of Fujifilm delivering a Non-Conforming Batch, then
this shall be discussed, reviewed and resolved by the next meeting of the Joint Steering Committee. 

  

	8.4	 Fujifilm may invoice the Customer for the Charges in respect of each Program in accordance with the terms set
out in Schedule 1. 

  

	8.5	 Fujifilm may invoice the Customer for Charges [***] at any time following its notice pursuant to clause 8.2. If
there is a dispute regarding the number of unrealised Batches of Product, then Fujifilm may [***] and [***] at the following Joint Steering Committee meeting. 

 

	8.6	 If the Drug Product is or will be marketed in countries [***] the Customer will [***] for all of
Fujifilm’s country-specific activities for the approval and marketing of the Product in those countries. 

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	17	 	

	8.7	 The Customer shall pay each invoice issued to it by Fujifilm within [***] of the date of invoice, in full and
in cleared funds [***] by electronic transfer to the financial institution specified in the relevant invoice. 

  

	8.8	 The Charges are [***], and which shall be payable by the Customer to Fujifilm [***]. 

 

	8.9	 If there is a change in the rate of Tax payable or in the Tax treatment of some or all of the services provided
by Fujifilm or the Product, a change of law or practice or interpretation of the existing legislation or revised determination by HMRC (Her Majesty’s Revenue and Customs) or the IRS (Internal Revenue Service), or the supply of product by
Fujifilm has been incorrectly regarded as Tax exempt, or if the courts rule Tax is chargeable, then the Customer agrees that Fujifilm shall be entitled, where Tax is imposed on a supply by Fujifilm under or in connection with this Agreement
(including the retrospective application of Tax upon services which Fujifilm has already performed and which have previously been invoiced on a Tax exempt basis), to invoice the Customer (in a valid Tax invoice) for a sum equal to the amount of the
Tax which becomes due on that supply [***]. The Customer shall pay those invoices in accordance with clause 8.7. 

  

	8.10	 The Customer shall: 

 

	 	8.10.1	 [***] taxes, charges, levies, assessments and other fees of any kind imposed by governmental or other authority
in respect of the purchase, importation, exportation, sale or other distribution of the Products and any other materials delivered to it by Fujifilm in connection with the Program; and 

 

	 	8.10.2	 make all payments under this Agreement without withholding or deduction of, or in respect of, any tax unless
required by law. If any such withholding or deduction is required, the Customer shall, when making the payment to which the withholding or deduction relates, [***]. 

 

	8.11	 Without prejudice to any other right or remedy that it may have, if the Customer fails to pay any sum to
Fujifilm on the due date for payment: 

  

	 	8.11.1	 the Customer shall pay interest on the overdue amount at the rate of [***]. Such interest shall be payable in
respect of the period from the due date until actual payment of the overdue amount (whether before or after judgment) in accordance with clause 8.7; and 

  

	 	8.11.2	 (except where the Customer has complied with its obligations in clause 8.12 below) Fujifilm may notify the
Customer that if it does not pay Fujifilm will suspend work on the Program, and if payment is not made within [***] of such notice, Fujifilm may suspend such work until payment has been made in full. 

 

	8.12	 If the Customer disputes the payment of any Charges or a part of them, the Customer shall:

  

	 	8.12.1	 notify Fujifilm of the disputed amount within [***] of its receipt of the invoice in which such disputed amount
is included giving reasonable details of the dispute; and 

  

	 	8.12.2	 pay the amount of Charges not in dispute in accordance with clause 8.7, and the dispute shall be dealt with
under the dispute resolution process set out in clause 17. 

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	18	 	

	8.13	 If the Customer fails to pay any sum which is not the subject of a bona fide dispute under clause 8.12 when the
same is due in accordance with clause 8.7 then Fujifilm may elect, at its discretion, to treat such non-payment as a material breach this Agreement under clause 15.1. 

 

	8.14	 A Party shall not be entitled to withhold, set off or reduce payment of any amounts payable under this
Agreement by any amounts which it claims are owed to it by another Party under this Agreement or any other agreement. 

  

	9.	 LIABILITY 

  

	9.1	 The Parties agree that: 

 

	 	9.1.1	 the potential extent of Liability arising from the supply of the Product is better known to the Customer than
to Fujifilm; 

  

	 	9.1.2	 the potential extent of such Liability may be disproportionate to Charges agreed for Fujifilm’s supply of
the Product; 

  

	 	9.1.3	 the Customer is better able to, and should, insure against any Liabilities the Customer might suffer,

 and that consequently Fujifilm may restrict its Liability as set out in this clause 9 and the Customer should Indemnify
Fujifilm in accordance with clauses 9.3, 9.4 and 9.5.3 and the Parties agree that clause 9.2 does not limit or exclude the Customer’s Liability to Fujifilm under those indemnities. 

 

	9.2	 SAVE THAT NOTHING IN THIS AGREEMENT LIMITS OR EXCLUDES THE LIABILITY OF EITHER PARTY TO THE OTHER FOR ANY
LIABILITY THAT IS NOT PERMITTED TO BE LIMITED OR EXCLUDED BY LAW (INCLUDING DEATH OR PERSONAL INJURY CAUSED BY A PARTY’S NEGLIGENCE), NOR IN RESPECT OF CLAIMS MADE BY FUJIFILM FOR FULFILMENT OF THE MINIMUM VOLUME COMMITMENTS:

  

	 	9.2.1	 EXCEPT IN RESPECT OF [***], [***]: 

 

	 	(a)	 UNLESS CLAUSE 9.2.1(B) APPLIES, [***]; OR 

 

	 	(b)	 FOR [***]. 

  

	 	9.2.2	 THE PARTIES AGREE TO DISCUSS AN ADJUSTMENT OF [***] IN CASE OF A CHANGE [***]. 

 

	 	9.2.3	 EXCEPT TO THE EXTENT ARISING FROM GROSS NEGLIGENCE OR WILFUL MISCONDUCT, NEITHER PARTY SHALL BE LIABLE, WHETHER
IN CONTRACT, TORT (INCLUDING NEGLIGENCE), FOR BREACH OF STATUTORY DUTY OR OTHERWISE, ARISING UNDER OR IN CONNECTION WITH THIS AGREEMENT FOR: LOSS OF PROFIT; LOSS OF BUSINESS; DEPLETION OF GOODWILL; LOSS OF ANTICIPATED SAVINGS; LOSS OR CORRUPTION OF
DATA OR INFORMATION; OR ANY SPECIAL, INDIRECT, CONSEQUENTIAL OR PURE ECONOMIC LOSS, COSTS, DAMAGES, CHARGES OR EXPENSES, [***]. 

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	19	 	

	9.3	 Liability for Product and Drug Product: the Customer shall Indemnify Fujifilm from and against all
Liabilities incurred by Fujifilm or its Affiliates arising out of or resulting from [***] the Product or the Drug Product [***]. 

  

	9.4	 Liability for the Process: the Customer shall indemnify Fujifilm from and against all Liabilities
incurred by Fujifilm or its Affiliates arising out of or resulting from [***] the Process (or any part of the Process) except to the extent that [***]. 

  

	9.5	 Liability for Non-Conforming Batches: 

  

	 	9.5.1	 THE PROVISIONS OF CLAUSE 6 SHALL APPLY TO NON-CONFORMING BATCHES AND
FUJIFILM SHALL [***]. 

  

	 	9.5.2	 [***] IN RESPECT OF NON-CONFORMING BATCHES OR THE USE BY THE CUSTOMER
OF NON-CONFORMING BATCHES. 

  

	 	9.5.3	 If the Non-Conforming Batch is delivered to the Customer pursuant to
clause 6, [***]. 

  

	 	9.5.4	 The Customer uses any material produced in a Non-Conforming Batch at
its own risk and shall undertake such tests as are necessary in order to satisfy itself that such materials are fit for the purposes for which the Customer proposes to use such materials. 

 

	9.6	 Recall:  

 

	 	9.6.1	 If the Customer is required by a Regulatory Authority or voluntarily chooses to initiate a recall or withdrawal
of any Drug Product (“Recall”), the Customer shall notify Fujifilm. 

  

	 	9.6.2	 Fujifilm shall provide all reasonably requested assistance and information to Customers and cooperate with the
Customer to implement the Recall in accordance with the protocols and procedures contained in the Quality Agreement. 

  

	 	9.6.3	 The Customer shall [***], unless the sole cause of the Recall is that the Product incorporated into the Drug
Product is agreed pursuant to clause 6 to be a Non-Conforming Batch (in which case clause 9.6.4 will apply). If the cause of the Non-Conforming Batch is [***] attributed
to the [***], then this will be an item for which the Customer is entirely responsible. 

  

	 	9.6.4	 If a Recall of a Batch from sale is necessary and Customer can prove that the Recall was due to a Non-Conforming Batch of Product and the cause of the Batch being a Non-Conforming Batch is a failure by Fujifilm to comply with clause 5.1, Fujifilm shall [***]:

  

	 	(a)	 [***]; and 

  

	 	(b)	 [***], 

such [***] being subject to [***]. 
  

	 	9.6.5	 If the sole cause of the Recall is that the Product incorporated into the Drug Product is agreed pursuant to
clause 6 to be a Non-Conforming Batch and that the Non-Conformity was known to the Parties when the Product was Delivered, then clause 9.5 shall apply in respect of the Non-Conforming Batch. 

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	20	 	

	9.7	 FUJIFILM GIVES NO, AND DISCLAIMS ANY, WARRANTIES, UNDERTAKINGS OR SIMILAR TERMS WHATSOEVER IN RESPECT OF ANY
ADVICE OR ASSISTANCE GIVEN BY FUJIFILM IN CONNECTION WITH [***]; AND FUJIFILM SHALL HAVE NO LIABILITY TO THE CUSTOMER IN CONNECTION WITH ANY SUCH ADVICE OR ASSISTANCE. 

 

	9.8	 ALL WARRANTIES, CONDITIONS AND OTHER TERMS, EXPRESS (OTHER THAN THOSE SET OUT IN THIS AGREEMENT) OR IMPLIED,
STATUTORY, CUSTOMARY OR OTHERWISE WHICH BUT FOR THIS CLAUSE 9 WOULD OR MIGHT SUBSIST IN FAVOR OF THE CUSTOMER, ARE (TO THE FULLEST EXTENT PERMITTED BY LAW) EXCLUDED FROM THIS AGREEMENT INCLUDING, IN PARTICULAR, ANY IMPLIED WARRANTIES RELATING TO
MERCHANTABILITY, FITNESS FOR A PARTICULAR USE AND NON-INFRINGEMENT. 

  

	9.9	 No claim for Liabilities incurred pursuant to the Quality Agreement may be made under the Quality Agreement by
either Party. Accordingly, performance of the Quality Agreement shall be deemed to be performance under this Agreement and as such any breach of the Quality Agreement shall be deemed to be a breach of this Agreement and all Liabilities shall be
construed and limited in accordance with this clause 9. 

  

	9.10	 Each Party agrees to take all reasonable steps to mitigate any Liabilities that it may seek to claim from the
other under or in connection with this Agreement including pursuant to any Indemnity. 

  

	9.11	 If a Party is entitled to benefit from an Indemnity (the “Indemnified Party”) from the other
Party (the “Indemnifying Party”) in accordance with this Agreement (an “Indemnity Claim”), the Indemnified Party shall notify the Indemnifying Party in writing of the Indemnity Claim (providing all necessary
details) and the Indemnifying Party shall at its own expense conduct all negotiations and any litigation arising in connection with the Indemnity Claim provided always that: 

 

	 	9.11.1	 the Indemnifying Party shall consult the Indemnified Party on all substantive issues which arise during the
conduct of such litigation and negotiations and shall take due and proper account of the interests of the Indemnified Party; 

  

	 	9.11.2	 the Indemnifying Party shall not settle or compromise the Indemnity Claim without the Indemnified Party’s
prior written consent (not to be unreasonably withheld or delayed) and shall ensure that any settlement or compromise does not include a statement as to or an admission of fault, culpability or a failure to act by or on behalf of the Indemnified
Party; 

  

	 	9.11.3	 the Indemnified Party shall not make any admissions or admit liability in relation to the Indemnity Claim or
otherwise settle any Indemnity Claim without the written agreement of the Indemnifying Party; and 

  

	 	9.11.4	 the Indemnified Party shall fully cooperate and assist the Indemnifying Party, at the Indemnifying Party’s
cost and expense, in relation to the Indemnity Claim (without limiting the extent of the Indemnity). 

  

	10.	 INSURANCE 

  

	10.1	 Without prejudice to the allocation of liability detailed in clause 9, each Party shall at its own cost be
solely responsible for taking out and maintaining in force during the term those policies of insurance required by law. 

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	21	 	

	11.	 INTELLECTUAL PROPERTY 

 

	11.1	 Subject to clause 11.2 neither Party shall acquire any right, title or interest in the other Party’s
Background IP. 

  

	11.2	 The Customer grants to Fujifilm a [***] for the exclusive purpose of [***]. Customer [***].

  

	11.3	 All title to and all rights and interest in any Customer Foreground IP shall vest in Customer. Fujifilm hereby
assigns to the Customer all title to and all rights and interest it owns in any Customer Foreground IP. 

  

	11.4	 All title to and all rights and interest in any Fujifilm Foreground IP shall vest in Fujifilm. The Customer
hereby assigns to Fujifilm all title to and all rights and interest it owns in any Fujifilm Foreground IP. 

  

	11.5	 If requested to do so by the other Party, each Party shall at the expense of the requesting Party execute all
documents and do all such further acts as the requesting Party may reasonably require to perfect the assignment under clause 11.3 or 11.4. 

  

	11.6	 Fujifilm grants to Customer a [***] for the exclusive purpose of [***]. Fujifilm [***]. 

 

	12.	 INTELLECTUAL PROPERTY INDEMNITY 

 

	12.1	 Fujifilm shall fully Indemnify the Customer from and against all Liabilities incurred by the Customer or its
Affiliates arising out of any third party claim that [***]. 

  

	12.2	 The Customer shall fully Indemnify Fujifilm from and against all Liabilities incurred by Fujifilm or its
Affiliates arising out of any third party claim that: 

  

	 	12.2.1	 [***]; or 

  

	 	12.2.2	 [***], 

[***]. 
  

	12.3	 If a third party claim is made in accordance with clause 12.1 or 12.2 then the Indemnified Party may require
the Indemnifying Party to prove that it has adequate financial means to pay out any amount finally awarded to such party by a competent court of law under the indemnity provisions provided for in those clauses (for example by way of set aside
capital or insurance). If the Indemnifying Party cannot so prove it has the financial standing to meet its obligations with respect to the Indemnities under the applicable clause then the Indemnified Party has the option to terminate this Agreement
on written notice. If Fujifilm exercises its option to terminate under this clause 12.3 then (without prejudice to the survival of the relevant Indemnity obligations) such termination shall be treated as a termination by Fujifilm under clause 15.1.

  

	13.	 CONFIDENTIALITY 

 

	13.1	 Each Party (the “Receiving Party”) agrees with the other (the “Disclosing
Party”): 

  

	 	13.1.1	 to keep the Disclosing Party’s Confidential Information confidential; 

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	22	 	

	 	13.1.2	 not to access or use the Disclosing Party’s Confidential Information save for complying with its
obligations under this Agreement or, if applicable, any confidentiality disclosure agreement then in force between the Parties; 

  

	 	13.1.3	 not to disclose the Disclosing Party’s Confidential Information to a third party other than to the
Receiving Party’s: 

  

	 	(c)	 Affiliates; 

  

	 	(d)	 officers and employees and those of its Affiliates that need to know the Confidential Information for the
purpose of performing its obligations under this Agreement; 

  

	 	(e)	 contractors and sub-contractors, professional advisers, consultants and
agents and those of its Affiliates who are engaged to advise that Party in connection with the Program or this Agreement; and 

  

	 	(f)	 any other person to whom the Disclosing Party agrees in writing that Confidential Information may be disclosed
in connection with the Program, 

 the “Authorized Third Parties”. 

 

	13.2	 The Receiving Party shall procure that each of the Authorized Third Parties keeps the Disclosing Party’s
Confidential Information confidential in accordance with this clause 13 and shall remain fully liable to the Disclosing Party for any act or omission of any of the Authorized Third Parties. 

 

	13.3	 The Receiving Party shall within [***] of receipt of the Disclosing Party’s written request (including
after termination of this Agreement): 

  

	 	13.3.1	 deliver up to the Disclosing Party all items and copies of all or any Confidential Information of the
Disclosing Party; 

  

	 	13.3.2	 expunge and/or make irretrievable all Confidential Information of the Disclosing Party from any computer or
other similar device in which it is stored and, if further requested, certify in writing signed by an authorized representative that it has done the same (provided that this clause 13.3.2 shall not apply to automatically archived electronic files or
electronic back-ups made in the ordinary course of business, on secured central servers, which cannot reasonably be deleted and such electronic files shall be retained subject to the obligations of confidence
set out in this clause 13); and 

  

	 	13.3.3	 destroy all hard copies of notes, analyses or memoranda containing the Disclosing Party’s Confidential
Information (and, if further requested, certify in writing signed by an authorized representative that it has done the same) 

provided that the Receiving Party shall be entitled to retain copies of the Confidential Information to enable it to monitor its obligations
under this Agreement or which is required to be maintained by Applicable Laws or a Regulatory Authority subject always to the obligations of confidence under this Agreement. 

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	23	 	

	13.4	 Confidential Information shall not include information which: 

 

	 	13.4.1	 is, or becomes, generally available to the public other than as a direct or indirect result of the information
being disclosed by the Receiving Party or its Authorized Third Parties in breach of this Agreement (except that any compilation of otherwise public information in a form not publicly known shall still be treated as Confidential Information);

  

	 	13.4.2	 was available to the Receiving Party on a non-confidential basis prior
to disclosure by the Disclosing Party; 

  

	 	13.4.3	 was, is, or becomes available to the Receiving Party on a
non-confidential basis from a person who, to the Receiving Party’s knowledge, is not under any confidentiality obligation in respect of that information; 

 

	 	13.4.4	 was lawfully in the possession of the Receiving Party before the information was disclosed by the Disclosing
Party; 

  

	 	13.4.5	 is developed by or for the Receiving Party independently of the information disclosed by the Disclosing Party;

  

	 	13.4.6	 is necessarily disclosed by the Receiving Party pursuant to a statutory or regulatory obligation, but then only
to the extent of such required disclosure and save that the Receiving Party shall, to the extent it is lawful to do so, give prompt notice to the Disclosing Party of any such potential disclosure and allow the Disclosing Party a reasonable
opportunity to limit such disclosure; or 

  

	 	13.4.7	 the Disclosing Party and the Receiving Party agree in writing is not confidential. 

 

	13.5	 If a Party concludes that a copy of this Agreement must be filed with the United States Securities Exchange
Commission or other regulatory agency (“SEC”) (or equivalent foreign agency or a securities exchange), such Party will use all reasonable efforts to provide the other Party with a copy of this Agreement showing any provisions hereof as to
which the Party proposes to request confidential treatment, and to provide the other Party with an opportunity to comment on any such proposed redactions and to suggest additional redactions. The filing Party will take such other Party’s
reasonable comments into consideration before filing the Agreement. 

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	24	 	

	14.	 CHANGE 

  

	14.1	 If a party wishes to change any aspect of this Agreement or any Scope of Work then the parties shall agree any
such changes in a change order drafted in Fujifilm’s standard format and agreed in writing and signed by both parties (and such change shall be referred to as a “Change”). 

 

	14.2	 If there is a change to Applicable Law which comes into effect after the Effective Date that adversely affects,
or is likely to adversely affect, production of Product by the Process when conducted in accordance with Fujifilm’s standard operating procedures or methods, and within the declared constraints of the Facility then the Parties will enter into a
Change to accommodate that change of Applicable Law, the cost of which shall be allocated as follows: 

  

	 	14.2.1	 if the change to Applicable Law specifically relates to the Product, Process or Dedicated Equipment then [***];
and 

  

	 	14.2.2	 if the change to Applicable Law relates to the Facility (including equipment other than Dedicated Equipment) as
it is operated by Fujifilm for purposes of the Program then [***]. 

  

	14.3	 If Fujifilm decides to implement a Change to the Facility (including equipment other than Dedicated Equipment)
without this being necessitated by changes in Applicable Law, then [***] 

  

	14.4	 In determining the appropriate allocation of charges for a Change other than one initiated pursuant to clause
14.2 and 14.3, if not agreed by the parties then either party may refer the Change to the Joint Steering Committee that may offer a non-binding opinion on the allocation of costs. The Joint Steering Committee
shall consider that Fujifilm will typically receive the benefit of [***], and the Customer will typically receive the benefit of [***]. Other improvements will be shared equitably as negotiated by the Joint Steering Committee. 

 

	14.5	 If the Parties are unable to agree a Change to accommodate a change of Applicable Law, Fujifilm may terminate
any affected Order (or part of it) or this Agreement without any liability to the Customer by giving written notice to the Customer if Fujifilm reasonably believes that it will be unable to carry out and complete such Order in accordance with this
Agreement or any future purchase order (as the case may be) due to the change of Applicable Law. 

  

	15.	 TERMINATION AND CONSEQUENCES 

 

	15.1	 Termination for cause: Either Party shall be entitled to terminate this Agreement (and all Orders
made under it) immediately upon giving notice to the other if: 

  

	 	15.1.1	 the other Party commits a material breach of this Agreement and such breach: 

 

	 	(a)	 is not capable of remedy (a breach shall be considered capable of remedy if the Party in breach can comply with
the provision in question in all respects other than as to time of performance); or 

  

	 	(b)	 is capable of remedy, and the breaching Party fails to remedy the breach within a reasonable period after
receipt of notice giving full particulars of the breach and requiring it to be remedied, provided, however, that such cure period shall be suspended during any time that a Party seeks resolution of a dispute as to whether an alleged material breach
occurred pursuant to clause 17; 

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	25	 	

	 	15.1.2	 the other Party takes any step or action in connection with its entering administration, provisional
liquidation or any composition or arrangement with its creditors (other than in relation to a solvent restructuring), being wound up (whether voluntarily or by order of the court, unless for the purpose of a solvent restructuring), having a receiver
appointed to any of its assets or ceasing to carry on business or, if he step or action is taken in another jurisdiction, in connection with any analogous procedure in the relevant jurisdiction; or 

 

	15.2	 Termination for change in Control of Fujifilm 

 

	 	15.2.1	 The Customer may terminate this Agreement at any time by giving Fujifilm not less than 2 (two) years’
prior written notice to Fujifilm if Fujifilm has a change in Control and the new Controlling entity is [***]. 

  

	 	15.2.2	 The right to terminate in clause 15.2.1 must be exercised by the Customer within [***] of the date the Customer
is notified by Fujifilm of the change in Control of Fujifilm, after such period the right to terminate pursuant to clause 15.2.1 expires. 

  

	 	15.2.3	 The Customer’s rights in this clause 15.2 are without prejudice to any prior commitment to minimum
purchase commitments for future years, which will continue to be due in accordance with clause 15.3.4. 

  

	15.3	 Consequences of Termination 

 

	 	15.3.1	 The termination of this Agreement shall be without prejudice to the rights and remedies of either Party which
may have accrued up to the date of termination. 

  

	 	15.3.2	 If the Customer terminates this Agreement in whole or in part pursuant to clause 2.3, 2.4 or 15.2, or Fujifilm
terminates this Agreement under clauses 15.1, the Customer shall pay: 

  

	 	(a)	 the Charges for the Minimum Annual Quantity for each Production Year up to the date that the Customer has
provided commitment; 

  

	 	(b)	 (if higher than the corresponding Minimum Annual Quantity) in respect of the [***] Half Years that follow the
date of termination, the Charges for the actual forecast volume (based on the forecast applicable at the termination date), subject to adjustment to the lowest permitted variation to those forecast volumes, as detailed in clause 2.2 of Schedule 2,

 together with, in each case, unpaid Pass Through Costs incurred prior to such termination. Fujifilm shall deliver all
Product Ordered during the notice period in accordance with the terms of this Agreement. 

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	26	 	

	 	15.3.3	 On termination of this Agreement for any reason whatsoever: 

 

	 	(a)	 save as set out in clause 0 the relationship of the Parties shall cease and any rights or licenses granted
under or pursuant to this Agreement shall cease to have effect save as (and to the extent) expressly provided for in this clause 15; 

  

	 	(b)	 the provisions of the following clauses together with any provision which expressly or by implication is
intended to come into or remain in force on or after termination shall continue in full force and effect clauses 1, 8, 9, 0, 12, 13, 15, 17, 19, and 23; and 

  

	 	(c)	 the Customer shall immediately pay to Fujifilm all of Fujifilm’s outstanding unpaid invoices and interest
and, in respect of Batches and other services supplied (or would have been supplied but for termination) but for which no invoice has been submitted, Fujifilm may submit an invoice, which shall be payable immediately on receipt.

  

	 	15.3.4	 If Fujifilm terminates this Agreement under clause 15.1 or the Customer terminates this Agreement under clause
15.2 or the Customer terminates the Intermediate Product aspects of this Agreement pursuant to clause 2.4, then the Customer shall pay: 

  

	 	(a)	 the Charges for any Batch that, but for termination, would have been supplied pursuant to an Order placed prior
to termination; 

  

	 	(b)	 the Charges for each Batch that the Customer has committed to (as detailed in Schedule 2) prior to termination
(as may be adjusted in accordance with a Change addressing capacity expansion) (in any case including the Minimum Annual Quantities for each year); 

  

	 	(c)	 any [***] incurred prior to termination in respect of items that Fujifilm will no longer be able to use.

  

	 	15.3.5	 Technology Transfer. 

 

	 	(a)	 On termination of this Agreement with respect to the Products or the Intermediate Products Fujifilm shall
transfer to the Customer copies of all documentation and all other records necessary for production of Products, or Intermediate Products as may apply, in a manner compliant with Applicable Law; provided, however, that Fujifilm may redact any
portion of any such records that contain information not related to the Products or the Process. 

  

	 	(b)	 Fujifilm shall [***] enable the Customer to transfer manufacture of such Product after the date of termination,
disclose to the Customer or a third party contract manufacturing organization, (i) [***] and (ii) upon reasonable notice cause its employees engaged in the manufacture of the Products to meet with representatives of the Customer, [***];

  

	 	(c)	 if any Background IP of Fujifilm is incorporated into the Process and the Customer or a third party contract
manufacturing organisation will require the Background IP to operate the Process, Fujifilm [***] a licence for the use of Background IP, [***]; 

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	27	 	

	 	(d)	 the cost of the technology transfer will be borne by [***] on the following basis (i) if the Customer
terminates or Fujifilm terminates pursuant to clause 15.1, [***] will pay [***]; or (ii) if Fujifilm terminates for any other reason, [***] will pay [***]. 

 

	16.	 FORCE MAJEURE 

 

	16.1	 Subject to clause 16.2, neither Party shall be liable to the other for any delay or non-performance of its obligations under any this Agreement (except for the payment of money) arising from a Force Majeure Event. 

 

	16.2	 If either Party is delayed or prevented from performing its obligations due to a Force Majeure Event such Party
shall: 

  

	 	16.2.1	 give notice of such Force Majeure Event to the other Party as soon as reasonably practical stating the
commencement date and extent of such delay or prevention, the cause thereof and its estimated duration; 

  

	 	16.2.2	 use reasonable endeavours to mitigate the effects of such Force Majeure Event; and 

 

	 	16.2.3	 resume performance of its obligations as soon as reasonably practicable. 

 

	16.3	 If the Force Majeure Event in question continues for more than [***] the Customer may give notice in writing to
Fujifilm to terminate this Agreement. If the Force Majeure Event in question continues for more than [***] Fujifilm may give notice in writing to the Customer to terminate this Agreement. The notice to terminate must specify the termination date,
which must not be less than [***] after the date on which the notice is given, and once such notice has been validly given, this Agreement will terminate on that termination date. 

 

	17.	 DISPUTE RESOLUTION 

 

	17.1	 If there is a dispute in relation to or in connection with the QA Documents, such dispute shall be dealt with
in accordance with the procedures set out in the Quality Agreement. 

  

	17.2	 In respect of any dispute concerning this Agreement (other than a dispute in connection with the QA Documents)
that is not resolved in the Joint Steering Committee the Parties shall seek to resolve the matter as follows: 

  

	 	17.2.1	 if the dispute is not resolved within [***] of its referral to the Program Managers it shall be referred to the
decision of Fujifilm’s Chief Business Officer and the Customer’s SVP of Product Supply; and 

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	28	 	

	 	17.2.2	 if the dispute is not resolved within [***] of its referral to Fujifilm’s Chief Business Officer and the
Customer’s SVP of Product Supply it shall be referred to the decision of each Party’s President or Chief Executive Officer (as applicable/appropriate). 

 

	17.3	 If the dispute between the Parties is not resolved having applied the process set out at clause 17.2 then
either Party may request that the dispute is settled under the Rules of Arbitration of the International Chamber of Commerce. The arbitration shall be held in [***], and English shall be the language used in the arbitration. The number of
arbitrators shall be determined in accordance with the applicable rules. 

  

	17.4	 Notwithstanding the provisions of this clause 17 either Party may commence or take proceedings or seek remedies
before the courts or any other competent authority for interim, interlocutory or injunctive remedies in relation to this Agreement. 

  

	18.	 AUDIT 

  

	18.1	 The Customer may carry out audits at the times, and in accordance with the terms, set out in the Quality
Agreement provided that access by the Customer and/or its representatives to records, information and systems shall be on a supervised basis, subject to the Customer complying with the security and confidentiality requirements of Fujifilm to protect
information which relates to anything other than the Programs and shall be limited to a maximum of [***]. During such audits Ascendis may be accompanied by potential business and/or licensing partners subject to reasonable prior notice to Fujifilm.

  

	18.2	 Audit access shall not be extended to Fujifilm’s confidential records, including details of financial
transactions and contracts with third parties that relate to this Agreement. 

  

	18.3	 If Fujifilm is in material breach of this Agreement or if the Customer reasonably believes that Fujifilm is in
material breach of this Agreement, the Customer may upon giving reasonable written notice to Fujifilm carry out an audit on the same basis as in clauses 18.1 and 18.2. 

 

	18.4	 Additional audits (other than those carried out pursuant to clause 18.3), such as those required for FDA
approvals or mock-Pre Approval Inspections, may be carried out on the same basis as in clauses 18.1 and 18.2 subject to (i) payment of Fujifilm’s costs and expenses and the agreement of a commercial
rate; and (ii) the Customer ensuring such audit will not delay or disrupt Fujifilm’s operations at the Facility. 

  

	19.	 NOTICES 

  

	19.1	 Subject to clause 19.2 the Parties may communicate with each other in any way that is normal in the course of
their business. 

  

	19.2	 Any notice given under clauses 2, 8, 9, 12, 13, 15, 16, 17, 18, 19.2, 20 or 21 shall only be effective if it is
in writing, sent to a Party at its address or email address and for the attention of the individual, as set out in Schedule 2 (or such other address, email address or individual as that Party may notify the other in accordance with this clause 19)
and is given in accordance with clauses 19.3 and 19.4 below. 

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	29	 	

	19.3	 Notice may be given by hand or sent by email, recorded delivery, registered post or airmail and will be deemed
to have been duly served: 

  

	 	19.3.1	 if delivered by hand, at the time and date of delivery; 

 

	 	19.3.2	 if sent by email, at the time and date of sending; 

 

	 	19.3.3	 If sent by reputable overnight courier (i.e., FedEx, UPS), at the time and date of delivery (as evidenced by
tracking information); 

  

	 	19.3.4	 if sent by recorded delivery or registered post, 48 (forty-eight) hours from the date of posting (such date as
evidenced by postal receipt); and 

  

	 	19.3.5	 if sent by registered airmail, five days from the date of posting, 

provided that, where in the case of delivery by hand or transmission by email, such delivery or transmission occurs either after 4.00pm on a
Business Day, or on a day other than a Business Day, service will be deemed to occur at 9.00am on the next Business Day. 
  

	19.4	 In proving service of a notice it will be sufficient to prove that delivery was made or that the envelope
containing the notice or document was properly addressed and posted (either by prepaid first class recorded delivery post or by prepaid airmail, as the case may be) or that no failed delivery message was received, as the case may be.

  

	20.	 EXPORT CONTROLS, MODERN SLAVERY AND CORRUPTION 

 

	20.1	 The Customer acknowledges that export and/or use of any Product may be subject to compliance with laws, rules
and regulations of bodies having jurisdiction over such operations. If the export or use of any Products is so controlled, it is the responsibility of the Customer to obtain any such approval required by any applicable laws, rules or regulations.

  

	20.2	 Each Party shall endeavour to hold itself and its suppliers to the highest performance, ethical and compliance
standards, including basic human rights, not engaging in any activity, practice or conduct which would constitute an offence under anti-slavery legislation in the United Kingdom or the U.S.A, encouraging fair and equal treatment for all persons, the
provision of safe and healthy working conditions, respect for the environment, the adoption of appropriate management systems and the conduct of business in an ethical manner. In performing its duties under this Agreement, each Party acknowledges
the value and importance of performance and ethical behaviour in its performance under this Agreement. 

  

	20.3	 Each Party warrants that on the Effective Date, it, its directors, officers or employees have not offered,
promised, given, authorized, solicited or accepted any undue pecuniary or other advantage of any kind (or implied that they will or might do any such thing at any time in the future) in any way connected with this Agreement and that it has taken
reasonable measures to prevent subcontractors, agents or other third parties, subject to its control or determining influence, from doing so. 

  

	20.4	 The Parties agree that, at all times in connection with and throughout the term of this Agreement, they will
comply with and that they will take reasonable measures to ensure that their subcontractors, agents or other third parties will comply with all applicable anti-corruption legislation including the Bribery Act 2010, if applicable, or the Foreign
Corrupt Practices Act 1977. 

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	30	 	

	20.5	 Each Party shall not do, or omit to do, any act that would cause one of the other Parties to be in breach of
any relevant anti-corruption legislation including the Bribery Act 2010, if applicable, or the Foreign Corrupt Practices Act 1977. 

  

	21.	 ASSIGNMENT AND SUB-CONTRACTING 

 

	21.1	 Either Party may assign or transfer all of its rights and responsibilities under this Agreement to:

  

	 	21.1.1	 an Affiliate provided that such Affiliate has reasonable financial creditworthiness; or 

 

	 	21.1.2	 a purchaser of all or substantially all of the equity of the assigning party provided that such third party has
reasonable financial creditworthiness; or 

  

	 	21.1.3	 a purchaser of all or substantially all of assets to which this Agreement relates provided that such third
party has reasonable financial creditworthiness; or 

  

	 	21.1.4	 a third party to which the Customer has licensed, divested or otherwise transferred its interest in the
Products, 

 but not otherwise without written consent of the other Party (such consent not to be unreasonably withheld or
delayed) and provided that (a) the assignee agrees in writing to assume all obligations undertaken by its assignor in this Agreement and (b) in relation to assignment in part no such assignment shall relieve the assigning Party of
responsibility for the performance of any of its obligations under this Agreement. 
  

	21.2	 If a Party assigns or transfers all or any of its rights and responsibilities under clause 21.1 it shall
immediately notify the other Party in writing. 

  

	21.3	 Fujifilm may sub-contract all or any of its obligations under this
Agreement [***]. 

  

	22.	 GENERAL 

  

	22.1	 Entire agreement: This Agreement contains all the terms which the Parties have agreed with respect to
their subject matter and supersede all previous agreements and understandings between the Parties (whether oral or in writing) relating to such subject matter. Each Party acknowledges and agrees that it has not been induced to enter into this
Agreement by a statement or promise which it does not contain. Each Party confirms that save as otherwise expressly set out in this Agreement, the other Party gives no warranties either in this Agreement or elsewhere in connection with the provision
of the Programs. Nothing in this clause 22.1 shall exclude or limit a Party’s liability for fraud, including fraudulent misrepresentation. 

  

	22.2	 Third Party rights: Save as expressly set out in this Agreement, the Parties do not intend that any
person who is not a Party to this Agreement shall have any right to enjoy the benefit or enforce any of the terms of this Agreement. 

  

	22.3	 Variations: With the exception of Changes, which shall be subject to clause 0, no variation of this
Agreement shall be valid unless in writing and signed by a duly authorized representative of each of the Parties. A Party is entitled assume that a representative of another Party is authorized to act on that Party’s behalf if that individual
is apparently or seemingly acting in the normal course of the business relationship. An exchange of emails shall not be capable of constituting an agreement to vary this Agreement. 

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	31	 	

	22.4	 Waiver: No failure or delay by a Party to exercise any right or remedy provided under this Agreement or
by law shall constitute a waiver of that or any other right or remedy, nor shall it preclude or restrict the further exercise of that or any other right or remedy. The single or partial exercise by either Party of any right, power or remedy under
this Agreement shall not in any circumstances preclude any other or further exercise of it, or the exercise of any right, power or remedy. A waiver by either Party of a breach of any provision of this Agreement shall not be considered as a waiver of
a subsequent breach of the same or any other provision of this Agreement. 

  

	22.5	 Severability: If any provision of this Agreement is found by any court or administrative body of
competent jurisdiction to be invalid, illegal or unenforceable in any jurisdiction then it shall be deemed modified to the minimum extent necessary to make it valid, legal and enforceable. If such modification is not possible that provision shall be
deemed to be omitted from this Agreement in so far as this Agreement relates to that jurisdiction and the validity and enforceability of that provision in other jurisdictions and the other provisions of this Agreement shall not be affected or
impaired. 

  

	22.6	 Counterparts: This Agreement may be executed in any number of counterparts. Either Party may enter into
this Agreement by executing a counterpart and all the counterparts taken together will constitute one and the same agreement. This Agreement shall not be effective until each Party has signed one counterpart. 

 

	23.	 GOVERNING LAW 

 

	23.1	 The formation, existence, construction, performance, validity and all aspects whatsoever of this Agreement or
any term of it and any issues, disputes or claims arising out of or in connection with it (whether contractual or non-contractual in nature) shall be governed by, and construed in accordance with, [***] law
and subject to clause 17.3 the Parties irrevocably submit to the jurisdiction of the courts of [***]. 

 IN WITNESS of the above
the Parties have signed this Agreement on the dates written on the Signature Page to be found after the schedules. 

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	32	 	

 Schedule 1 Charges 

 

	1.	 Batch Price 

 

	1.1	 The Batch Price for the Product is set out in the following table: 

[***] 
  

	1.2	 Notes relating to the above table: 

[***] 
  

	1.3	 The following are included / not included in the Batch Prices for Products: 

 

	 	1.3.1	 Batch Prices include: 

[***] 
  

	 	1.3.2	 Batch Prices do not include: 

[***] 
  

	1.4	 The Batch prices for [***] is set out in the following table: 

[***] 
  

	1.5	 Notes relating to the above table: 

 

	 	1.5.1	 [***] 

  

	1.6	 The following are included / not included in the Batch Prices for [***]: 

 

	 	1.6.1	 Batch Prices include: 

[***] 
  

	 	1.6.2	 Batch Prices do not include: 

[***] 
  

	1.7	 Reference to a “Campaign Price” is to the total of all applicable Batch Prices for a Campaign.

  

	1.8	 In respect of each Campaign of Product Customer shall pay: 

 

	 	1.8.1	 [***] 

  

	1.9	 Payments pertaining to clauses [***] above shall be [***], while payments pertaining to clause [***] above
shall be [***]. 

  

	1.10	 The Customer agrees that for every Production Year it will pay for the Minimum Annual Quantity even if it
places Orders for fewer Batches of the Product than the number of Batches of Product provided for in the Minimum Annual Quantity for that Production Year. Fujifilm will invoice the Customer for any such shortfall in Batches of the Product [***]. In
case where the likelihood of such a shortfall has been shared in the JSC, Fujifilm will make Commercially Reasonable Efforts to utilize the Facility during the period during which manufacture of the Batch was intended to take place (“Mitigation
Measures”) through the acquisition of new business. Fujifilm shall reduce the invoice by a sum equivalent to [***]. 

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	33	 	

	1.11	 In respect of each Campaign of [***] Reagent the Customer shall pay: 

 

	 	1.11.1	 [***] 

  

	2.	 Charges for [***] and Sub-Contracted Work

  

	2.1	 In addition to the Batch Price for each Batch, the Customer will pay Fujifilm for Consumables, [***] (the
“Pass Through Costs”) at a rate of [***]. The Pass Through Costs shall be payable when invoiced by Fujifilm in accordance with the provisions of paragraphs 2.3 and 2.4 below. [***] 

 

	2.2	 [***] 

  

	2.3	 Invoices for raw materials and consumables will be issued as follows: 

[***] 
 On completion of each
Campaign, Fujifilm shall calculate the [***] in respect of such Batch [***]. 
  

	3.	 Customer Deliverables and other materials on termination 

 

	3.1	 Within [***] of termination of this Agreement, the Customer shall notify Fujifilm what (if any) Customer
Deliverables the Customer wishes Fujifilm to deliver to the Customer and delivery of those Customer Deliverables shall take place in accordance with clause 7. If the Customer does not give any such notification to Fujifilm within [***] of
termination of this Agreement, Fujifilm may destroy such samples and/or cell banks without further notice [***]. 

Provided that the Customer has paid for any Materials in relation to which payment is due, Fujifilm shall deliver Materials to Customer in
accordance with clause 7. 
  

	4.	 Price Increases 

 

	4.1	 The Batch Price specified in paragraph 1 of this Schedule 1 shall be adjusted [***] in an amount equal to [***]

  

	4.2	 [***] 

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	34	 	

 Schedule 2 Forecasting and Orders 

 

	1.	 Minimum and Maximum Orders 

 

	1.1.	 The Minimum Annual Quantity is the number of Batches of Product that the Customer agrees to pay for during the
applicable Production Year as set out in paragraph 1.3 of this Schedule 2 or otherwise determined in accordance with paragraph 1.9 of Schedule 1. 

  

	1.2.	 The Maximum Annual Quantity is the maximum number of Batches of Product that Fujifilm agrees it can manufacture
for the Customer during the applicable Production Year. 

  

	1.3.	 The Minimum Annual Quantity and Maximum Annual Quantity for the initial Production Years are as follows:

  

							
	 PRODUCTION

YEAR
	  	 MINIMUM ANNUAL
QUANTITY*
	  	 [***]
	  	 MAXIMUM ANNUAL
QUANTITY*

	2020	  	[***]	  	[***]	  	[***]
				
	2021	  	[***]	  	[***]	  	[***]
				
	2022 and beyond	  	As per the forecast mechanism in paragraph 2 of this Schedule 2	  		  	As per the forecast mechanism in paragraph 2 of this Schedule 2[***]

  

	 	*	 Batches refers to Batches of Product ([***]) 

[***] 
  

	1.4.	 The Minimum Annual Quantity and Maximum Annual Quantity for each Production Year following the period specified
in the above table will [***]. 

  

	1.5.	 Fujifilm shall reserve capacity of [***] in addition to the Minimum Annual Quantity. If this additional
capacity is not required by the Customer it shall not form part of the Minimum Annual Quantity and will not be factored into the calculation of any shortfall volume in a Production Year (pursuant to clause 8.2). 

 

	2.	 Forecasting 

  

	2.1.	 By [***] (each a “Forecast Date”), the Customer shall provide to Fujifilm a forecast of its
requirements for Batches of Product for the [***] following the Forecast Date, broken down into 6 (six) month increments (each being a “Half Year”, the first Half Year commencing on the Forecast Date being known as the 1st Half Year and subsequent half Years being numbered accordingly). A reference in this paragraph 2 to the previous forecast shall mean the forecast issued at the immediately previous Forecast Date.

  

	2.2.	 Each forecast shall be subject to the following principles: 

 

	 	2.2.1.	 the forecast for [***] shall be binding and the subject of an Order made pursuant to paragraph 3;

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	35	 	

	 	2.2.2.	 from the Forecast Date that follows [***], the forecast for [***] shall not deviate from the corresponding
period in the previous forecast ([***]) by more than [***]; 

  

	 	2.2.3.	 from the Forecast Date that follows [***], the forecast for [***] shall not deviate from the corresponding
period in the previous forecast ([***]) by more than [***]; 

  

	 	2.2.4.	 prior to the Forecast Date that follows [***]: 

 

	 	2.2.4.1.	 the forecast for [***] shall not deviate from the corresponding period in the previous forecast ([***]) by more
than [***]; and 

  

	 	2.2.4.2.	 the forecast for [***] shall not deviate from the corresponding period in the previous forecast ([***]) by more
than [***]; 

  

	 	2.2.5.	 there shall be no restrictions on deviations in forecasts in [***]. 

 

	2.3.	 [***] 

  

	2.4.	 The Parties have agreed certain Minimum Annual Volumes, which are detailed in clauses 4.1. No Forecast may be
submitted for a quantity of Batches in a period that is less than the corresponding Minimum Annual Quantity. 

  

	2.5.	 Once a Forecast has been issued to Fujifilm it may not be varied unless the Parties agree a Change.

  

	2.6.	 If, in any Production Year, the Customer would like Fujifilm to manufacture a number of Batches in excess of
the Maximum Annual Quantity it shall notify Fujifilm in writing and the Parties will promptly discuss such request. Fujifilm may agree (in a Change) to manufacture an agreed number of Batches in excess of the Maximum Annual Quantity if it has
sufficient manufacturing capacity to do so ([***]) but nothing in this Agreement shall oblige Fujifilm to supply Batches in excess of the Maximum Annual Quantity in any Production Year unless it has agreed to do so in a Change.

  

	3.	 Ordering 

  

	3.1.	 The Customer will issue a written purchase order (the “Order”) for the Batches of Product it
requires to be supplied on the Forecast Date for all Batches of Product included in [***] of the forecast. The first Order placed by the Customer shall commit the Customer to all Batches of Product in [***] of the forecast. 

 

	3.2.	 Fujifilm shall acknowledge Orders in writing within [***] of receipt. 

 

	3.3.	 Once acknowledged by Fujifilm Orders are non-cancellable by either
Party. 

  

	3.4.	 Notwithstanding paragraphs 3.1 to 3.3, if the Customer fails to submit an Order for part or all of a binding
component of a forecast (which may include binding minimum volume commitments), the Customer shall be deemed to have placed such Order in line with the timescales set out in paragraph 3.1. 

 

	3.5.	 Orders, Order acknowledgements and/or other similar documentation submitted by either Party in conducting
activities under this Agreement are for administration purposes only and (notwithstanding any statement or terms stated within such documentation) shall not add to or modify the terms of this Agreement. 

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	36	 	

	3.6.	 Each order placed by the Customer shall be for [***] ([***]), save that it is acknowledged that the Customer
may place Orders for the Intermediate Product recombinant human growth hormone (hGH) or for inclusion bodies for [***]. 

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	37	 	

 Schedule 3 Addresses for Notice 

 

			
	 FDBK:
  

Contact: [***]
  

Address: Fujifilm Diosynth Biotechnologies, Belasis Avenue, Billingham, TS23 1LH, England

 
 Nominated email address: [***]
	  	 Copied to:
  

Contact: [***]
  

Address: Fujifilm Diosynth Biotechnologies, Belasis Avenue, Billingham, TS23 1LH, England

 
 Nominated email address: [***]

		
	 Customer:
  

Contact: [***]
  

Address: Tuborg Boulevard 12, DK-2900 Hellerup, Denmark

 
 Nominated email address: [***]
	  	 Copied to:
  

Contact: [***]
  

Address: Tuborg Boulevard 12, DK-2900 Hellerup, Denmark

 
 Nominated email address: [***]

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	38	 	

 Schedule 4 Customer Deliverables 

Supply the [***] in the volumes and by the dates required by Fujifilm to fulfil its commitments to the Customer, and to the specification required as part of
the Process. The required amount of [***] will be delivered to Fujifilm no later than [***] before the Product manufacture. [***] 

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	39	 	

 Schedule 5 Storage Agreement 

THIS AGREEMENT is effective from the date of the last signature and is between: 

 

	(1)	 FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED (a company registered in England under number 5803359)
whose registered address is Belasis Avenue, Billingham TS23 1LH (“Fujifilm”); and 

  

	(2)	 The Customer. 

TERMS AND CONDITIONS OF THIS AGREEMENT 
  

	1.	 Interpretation. The following words or phrases shall have the meaning given to them in the Schedule:
“Customer”; “Stored Items”; “Charges”; and “Facility”. The term “Storage Services” shall mean the storage by Fujifilm of the Stored Items in the agreed conditions
following adequate procedures, using equipment with adequate safeguards (e.g. alarms and emergency power supply), and all activities ancillary to that storage including, without limitation, taking items into storage and releasing items to Customer.

  

	2.	 Term. This Storage Agreement shall come into effect on the Effective Date of the Commercial Supply
Agreement. 

  

	3.	 Storage Services. Fujifilm shall store the Stored Items at the Facility(ies), provided that in each case
the location of the Stored Items meets the storage conditions specified in the Schedule. Each Facility shall be compliant with cGMP if applicable. Provision of the Storage Services does not grant Customer exclusivity over any area of a Facility.
Fujifilm shall determine, acting reasonably, the distribution of Stored Items between the Facilities and may specify that Stored Items be moved between Facilities in which case clause 5 shall apply. 

 

	4.	 Delivery of Stored Items. If the Stored Items are not in Fujifilm’s control as at the Effective
Date then the Stored Items will be delivered by Customer [***] the Facility (Incoterms 2010). The Stored Items will be delivered to Customer [***] the Facility (Incoterms 2010). [***] 

 

	5.	 Transportation of Stored Items between Facilities. Unless redistribution of the Stored Items is
specifically requested by Customer, Fujifilm shall be responsible for arranging transportation of the Stored Items between the Facilities during the term of this Agreement [***] subject to clause 7. 

 

	6.	 Packaging of Stored Items. Unless the Stored Items are used by Fujifilm in the manufacture of
Product(s), Fujifilm will package the Stored Items ready for transportation and/or delivery [***] and in accordance with Customer’s reasonable written instructions. 

 

	7.	 Risk in Stored Items. Risk in the Stored Items shall [***]. 

 

	8.	 Ownership of Stored Items and Insurance. The Stored Items shall be the property of Customer unless:
(i) expressly stated to the contrary in the Schedule; or (ii) the Stored Items contain Fujifilm proprietary intellectual property. 

  

	9.	 Charges. In consideration of the Storage Services, Customer shall pay to Fujifilm the Charges according
to the schedule. 

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	40	 	

	10.	 Value Added Tax (VAT). If VAT applies to Fujifilm’s services under this Agreement, [***]. If there
is any retrospective application of VAT on Fujifilm’s services that have already been performed and invoiced on a VAT exempt basis, or an increased amount of VAT being due as a result of a change in the VAT rate payable or the VAT treatment of
the services or a change in the law or practice or interpretation of existing legislation, Fujifilm may invoice Customer for such amounts and Customer will pay those invoices in accordance with clause 9. 

 

	11.	 Termination. This Storage Agreement shall terminate if and when the Supply Agreement terminates.

  

	12.	 Consequences of Termination or Expiry. At the end of this Agreement: (i) Customer shall immediately
pay to Fujifilm all outstanding sums whether or not yet invoiced; (ii) Fujifilm shall notify Customer in writing of any Stored Items that remain in the Facilities and, if Customer does not request delivery ([***] at the applicable Facility)
within [***] of the notice, Fujifilm may at its discretion dispose of the items [***]; (iii) any provision of this Agreement which expressly or impliedly has effect after termination will continue to be enforceable notwithstanding termination.
Termination of this Agreement shall not affect either Party’s accrued right and obligations at the date of termination. 

  

	13.	 Limitations of Liability. Save that nothing in this Agreement shall limit or exclude any liability which
Fujifilm is not permitted to limit or exclude by law; it is agreed that [***] 

  

	14.	 Confidentiality. Each Party agrees with the other to keep confidential the other Party’s
Confidential Information and not to use the other’s Confidential Information save for complying with its obligations under this Agreement. No disclosure may be made to third parties unless (and only to the extent that): (i) to service providers
or professional advisors under a duty of confidentiality; and (ii) it is necessary due to statutory or regulatory obligation. “Confidential Information” shall mean the fact of and terms of this Agreement and any other
information that is identified as being of a confidential or proprietary nature or that would be regarded as confidential by a reasonable business person. 

  

	15.	 Notices. Any notice required to be served by either Party to the other shall only be effective if it is
in writing and sent to a Party at its registered office for the attention of [***]. 

  

	16.	 Third Parties. No term of this Agreement shall be enforceable under the Contracts (Rights of Third
Parties) Act 1999 by a person who is not a Party to it. 

  

	17.	 Law and Jurisdiction. This Agreement is governed by [***] law and any dispute arising out of the
Agreement shall be subject to the non-exclusive jurisdiction of the [***] courts. 

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	41	 	

 SCHEDULE TO STORAGE AGREEMENT 

 

	1.	 Customer details 

The “Customer” is: 

ASCENDIS PHARMA A/S (a company registered in Denmark) whose registered address is Tuburg Boulevard 12,
DK-2900 Hellerup, Denmark (“Customer”). 
  

	2.	 Stored Items, agreed storage conditions, and charges 

The following are the Items which may be stored under this Storage Agreement together with the applicable Charges: 

[***] 
  

	3.	 Facilities 

The following are the location of the storage facilities used by Fujifilm (each being a “Facility”): 

[***] 
  

	4.	 Charges 

At the end of [***], Fujifilm shall prepare a statement specifying for each Stored Item how many units were stored and for how long, and shall issue an
invoice to Customer for the total amount, to be paid by Customer within [***]. 
  

	5.	 Inventory reports 

Fujifilm will provide a [***] overview summarising the quantities of the various items stored. 

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	42	 	

 Signature Page of Commercial Supply Agreement 

SIGNED for and on behalf of FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED: 

Signature: /s/ Paul Found 
 Name: Paul Found 

Title: COO 
 Date: 09 Jan 2019 

SIGNED for and on behalf of ASCENDIS PHARMA A/S: 

Signature: /s/ Michael Wolff Jensen 
 Name: Michael Wolff Jensen

 Title: Senior Vice President 
 Date: 18-Dec-2018 

  

					
	Fujifilm Ascendis Commercial Supply Agreement	 	43

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