COMMERCIAL SUPPLY AND SERVICES AGREEMENT - DRUG SUBSTANCE -

1.

Scope of the Agreement & Schedules

1.1.

▇▇▇▇▇▇▇▇▇▇ will perform on a non-exclusive basis the Services upon the terms and conditions of this Agreement as well as its Schedules.

1.2.

Attached to this Commercial Supply Agreement (“Agreement”) are the following Schedules which form an integral part of this Agreement:

Schedule A:

Definitions used in this Agreement;

Schedule B:

Commercial Terms for the Services;

Schedule C:

Legal Terms, including liabilities and limitation of liabilities;

Schedule D:

Latest agreed version of the Quality Agreement defining the delineation of the pharmaceutical responsibilities. This Schedule will be executed directly between Ultragenyx Pharmaceutical Inc., part of Ultragenyx group of companies (that is providing pursuant to separate intra group agreements quality oversight and support services on behalf of the Customer) and ▇▇▇▇▇▇▇▇▇▇.

Schedule E:

Compliance

1.3.

In the case of any inconsistencies between this Agreement, the Schedules and / or an Offer referring to it, this Agreement shall prevail, except for quality aspects and the definition of Territory after the Effective Date for which Schedule D shall prevail.

1.4.

Neither Party shall alter or adjust this Agreement or any Schedule to it without the prior written permission of the other Party.

2.

Customer’s Responsibilities

2.1.

Customer shall be responsible to

(i)

provide complete and accurate requirements to define the Specifications;

(ii)

provide ▇▇▇▇▇▇▇▇▇▇ with complete and accurate information (Material Data Safety Sheet) and sufficient FOC Material necessary to perform the Services.

2.2.

Customer shall supply FOC Material to ▇▇▇▇▇▇▇▇▇▇ according to Schedule B in line with [***] (Incoterm 2010). Customer is responsible that such material is (i) suitable for the Manufacturing of the Product, (ii) fits for the Services and (iii) pharmaceutically compliant.

2.3.

Customer shall inform ▇▇▇▇▇▇▇▇▇▇’▇ incoming goods department (▇▇▇▇▇▇▇▇▇▇▇▇@▇▇▇▇▇▇▇▇▇▇.▇▇) and the project manager of any delivery at least [***] Business Days before any such delivery to ▇▇▇▇▇▇▇▇▇▇ is initiated.

2.4.

In case that Customer provides cell substrates, cell lines or cell banks, Customer provides only aliquots to ▇▇▇▇▇▇▇▇▇▇ and safeguards that the primary seed lot, master cell bank or working cell bank as applicable is stored safely in another place. Customer confirms that it will provide all safety data and information available that are relevant for ▇▇▇▇▇▇▇▇▇▇’▇ safety requirements.

2.5.

Both Parties shall comply with Schedule E.

3.

▇▇▇▇▇▇▇▇▇▇ Responsibilities

3.1.

▇▇▇▇▇▇▇▇▇▇ shall comply with cGMP and with recognized industry standards, including, but not limited to applicable ICH guidelines and the pertaining laws and regulations.

3.2.

▇▇▇▇▇▇▇▇▇▇ will make available and maintain an adequate manufacturing site, validated processing equipment, the manufacturing processes for the products of the Customer in a validated state, trained and competent personnel with relevant knowledge and experience, and will ensure sufficient capacity to store the FOC material and the excipients needed and render the Services, and Manufacture of Product.

3.3.

All the responsibilities and obligation listed under section 3.1. and 3.2. will be covered by ▇▇▇▇▇▇▇▇▇▇ at their own expenses.

3.4.

▇▇▇▇▇▇▇▇▇▇ will notify the Customer immediately but not later than within [***] Business Days in the event of any potential failure to deliver Product within the agreed time lines.

3.5.

▇▇▇▇▇▇▇▇▇▇ will render the Services in a professional and ▇▇▇▇▇▇▇-like manner in accordance with this Agreement, including the Quality Agreement.

3.6.

▇▇▇▇▇▇▇▇▇▇ will Manufacture the Product in accordance with the terms of this Agreement and the responsibilities as set out in the Quality Agreement.

3.7.

▇▇▇▇▇▇▇▇▇▇ has to provide the Customer with a [***] Material inventory report by the [***] reflecting the inventory of FOC Material on the last day of the previous calendar month.

4.

Governance Model

4.1.

The partnership model includes a Steering Committee (as described in clause 4.2) and a Joint Working Team (as described in clause 4.13) focussing on operational execution. The Joint Working Team will be led by a project / relationship manager of each Party (“Joint Working Team Leads”).

4.2.

The Parties shall establish a Steering Committee consisting of 4 (four) permanent senior management individuals (“Committee Members”). Each Party will nominate [***] Committee Members.

4.3.

Either Party may replace its Committee Members by notice to the other Party.

4.4.

The Committee Members shall be appropriately qualified and experienced in order to make a meaningful contribution to the Steering Committee meetings.

4.5.

The purpose of the Steering Committee is to

(i)

establish and maintain an effective and efficient collaboration between the Parties;

(ii)

confirming the Joint Working Team Leads appointed by each Party;

(iii)

oversee the Joint Working Team’s performance in business review meetings;

(iv)

evaluate in good faith and ratify any technical, business process and / or quality Improvements proposed by the Joint Working Team;

(v)

act as escalation body for issue resolution;

(vi)

define the framework for continuous Improvement, mutual long-term objectives and priorities.

(vii)

any other topics assigned to it in compliance with this Agreement of following the mutual decision of the Parties.

4.6.

The Steering Committee shall conduct its discussions in good faith with a view to operating to the mutual benefit of the Parties.

4.7.

The Steering Committee shall meet as often as the Committee Members may determine (to this purpose the request of the Committee Members of each Party would be sufficient), but in any event no less than [***] per Calendar Year. Meetings can be held face-to-face or by teleconference, with minimum [***] per year. Either Party may request a meeting within [***] Business Days in urgent cases.

4.8.

The agenda (including, any pre-read material) shall be distributed to the participants latest [***] Business Days prior to the meeting. In addition to any other topics to be discussed in the agenda of the relevant meeting, the following matters shall be invariably discussed during the meetings of the Steering Committee:

(i)

company updates and strategic outlooks;

(ii)

decisions requested from the Joint Steering Committee;

(iii)

performance review (services, quality, relationship, financials);

(iv)

performance review of the Joint Working Team;

(v)

risk evaluation and associated risk mitigation projects;

(vi)

review status of past meeting action items;

(vii)

approval of target setting for Key Performance Indicators defined by Joint Working Team.

4.9.

Each Party may invite individuals with special skills to attend such meetings where it is considered to be relevant and appropriate.

4.10.

All decisions of the Steering Committee shall be made in good faith in the best interests of this Agreement and require a unanimous vote. In the event that the Steering Committee is unable to reach a decision on any matter after good faith attempts to resolve such disagreement in a commercially reasonable fashion and in any event if the Steering Committee is unable to decide within [***] Business Days, then such matter should be referred to the Executive Leadership of both Parties, who together shall use reasonable and good faith efforts to reach a

decision by consensus within [***] Business Days after such matter is referred to them.

4.11.

If the Executive Leadership does not reach consensus in accordance with clause 4.10., either Party may commence dispute resolution proceedings in accordance with the relevant provisions set out in this Agreement.

4.12.

The Steering Committee shall take minutes of its meetings and resolutions, which shall be promptly circulated to the Parties after each meeting for agreement. In case of any disagreement clauses 4.10. and 4.11. shall apply.

4.13.

The Parties shall establish a Joint Working Team, consisting of subject matter experts at minimum in the field of manufacturing operations, quality (“Joint Working Team Members”).

4.14.

Either Party may replace its Joint Working Team Members by notice to the other Party.

4.15.

The Joint Working Team Members shall be appropriately qualified and experienced in order to make a meaningful contribution to the Joint Working Team meetings.

4.16.

The purpose of the Joint Working Team is to:

(i)

drive and improve performance of Services and the Joint Working Team;

(ii)

deliver on Service goals;

(iii)

target setting for Key Performance Indicators (to be established; every Calendar Year by the 4^th quarter of the preceding Calendar Year) that shall include performance and Yield values agreed by the Joint Working Team Members and approved by the Steering Committee;

(iv)

manage and reduce aggregate risk, including lead times and safety stock management of Third Party Material;

(v)

manage issues related to Services;

(vi)

manage post-approval changes;

(vii)

maintain a collaborative and constructive relationship (at operational level);

(viii)

potentially propose any Improvement to the Steering Committee.

4.17.

The Joint Working Team shall conduct its discussion in good faith with a view to operating to the mutual benefit of the Parties.

4.18.

The Joint Working Team shall meet as often as the Joint Working Team Members may determine, but in any event [***]. Meetings can be held face-to-face or by teleconference, with minimum [***] per year.

4.19.

In addition to any other topics to be discussed in the agenda of the relevant meeting, the following matters shall be invariably discussed during the Joint Working Team meetings:

(i)

team member updates;

(ii)

performance review (services, quality, relationship, financials) by means of defined Key Performance Indicators;

(iii)

risk evaluation and associated risk mitigation projects;

(iv)

review status of past meeting action items.

4.20.

The Joint Working Team Members may invite individuals with special skills to attend such meetings where it is considered to be relevant and appropriate. Individuals belonging to a third party have to be mutually agreed. These invited individuals do not have voting powers.

4.21.

The quorum for the validity of the Joint Working Team meetings shall be [***] for each Party.

4.22.

All decisions of the Joint Working Team shall be made in good faith in the best interests of this Agreement and require a unanimous vote. In the event that the Joint Working Team is unable to reach a decision on any matter after good faith attempts to resolve such disagreement in a commercially reasonable fashion. Then such matter should be referred to and decided by the Steering Committee in a timely manner.

4.23.

The Joint Working Team shall take minutes of its meetings and resolutions, which shall be promptly circulated to the Parties after each meeting for agreement.

5.

Financial Audits

6.

Term and Termination

6.1.

This Agreement is effective as of the last date of signature (“Effective Date”) and will expire (if not terminated earlier in accordance with the Agreement’s provisions) 5 (five) years thereafter (“Initial Term”). The Agreement will be automatically extended for another 5 (five) years following the Initial Term. Customer may withdraw from this Agreement at will (without cause) with a pre-notice of 18 (eighteen) months at any time following the Initial Term. ▇▇▇▇▇▇▇▇▇▇ may withdraw from this Agreement at will (without cause) with a pre-notice of 36 (thirty-six) months at any time following the Initial Term.

6.2.

This Agreement may be terminated by the non-breaching Party giving written notice of such termination to the other party if the other Party breaches a material provision of this Agreement (including any delay for reasons attributable to ▇▇▇▇▇▇▇▇▇▇ in fulfilling Customer’s orders, which would lead to a market stock-out as long as Customer has fulfilled its obligation and is able to prove such fulfilment to have an appropriate safety stock of the product at all times during the Term of the Agreement to eliminate the risk of a market stock out and such breach remains uncured for [***] days following the breaching party’s receipt of written notice of such breach from the non-breaching party.

6.3.

Each Party shall be entitled to terminate this Agreement with immediate effect if:

(i)

any requirement / obligation mentioned in Schedule E is violated / breached by the respective other Party and / or its Affiliates;

(ii)

a Material Change in Control and Business Model of the respective other Party;

(iii)

the respective other Party infringes Party’s Intellectual Property Rights.

6.4.

Customer shall be entitled to terminate this Agreement with immediate effect if ▇▇▇▇▇▇▇▇▇▇ loses the right to operate under this Agreement following any decision from the competent authorities and / or revocation of the necessary approvals / regulatory permits (including FDA taking control of ▇▇▇▇▇▇▇▇▇▇ following a consent decree).

6.5.

Unless otherwise agreed in writing termination or expiration of this Agreement for any reason shall not relieve either Party or its Affiliates from their obligations under this Agreement until the date of such termination or expiration or to perform such obligations as described in Schedule E) that will survive for [***] years after the expiration or termination of this Agreement.

6.6.

Either Party may terminate this agreement at any time if ▇▇▇▇▇▇▇▇▇▇ is unable to deliver the Services agreed in this Agreement. In the event of Force Majeure for a period greater than [***] consecutive calender months.

6.7.

In any event of termination (including termination at will as per clause 6.1) of this Agreement triggered by any of the Parties or resulting from a Force Majeure event and upon written notice by Customer (“Transfer Request”), ▇▇▇▇▇▇▇▇▇▇ will start immediately to make available, in accordance with sections 2 and 3, Schedule C of this Agreement, the manufacturing technology from ▇▇▇▇▇▇▇▇▇▇ to Customer or a third party designated by the Customer and provide reasonable technical assistance to the Customer or such third party to operate the manufacturing process developed under the Master Service Agreement (dated August 31, 2012) and this Agreement in order to enable the Customer or such third party to continue the manufacturing and supply of Products (“Technology Transfer”). ▇▇▇▇▇▇▇▇▇▇ shall make reasonable efforts to complete the Technology Transfer within [***] months. The successful completion of the Technology Transfer shall be confirmed by the Joint Steering.

6.8.

▇▇▇▇▇▇▇▇▇▇ shall initiate Technology Transfer within [***] days after written notice from Customer requesting such initiation (“Initiation Notice”), which Initiation Notice may be made by Customer within [***] months after the date of the Transfer Request.

6.9.

Such a Technology Transfer cost will be borne by the Customer unless terminated by the Customer in line with the section 6.4. or terminated by ▇▇▇▇▇▇▇▇▇▇ according to section 6.1. In case of Force Majeure such a Technology Transfer cost will be equally borne by both Parties.

▇▇▇▇▇▇▇▇▇▇ Biopharma SE

Date:             December 6, 2017

Signature:     /s/ ▇▇▇▇▇ ▇▇▇▇▇▇▇

Name:           ▇▇. ▇▇▇▇▇ ▇▇▇▇▇▇▇

Position:        SVP Project Management

If second signature is required:

Date:             December 6, 2017

Signature:     /s/ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇

Name:           ▇▇▇▇▇▇ ▇▇▇▇▇▇▇

Position:        VP Commercial Management

Ultragenyx Europe GmbH

Date:             January 2, 2018

Signature:     /s/ ▇▇▇▇▇▇▇ ▇▇▇▇▇

Name:           ▇▇▇▇▇▇▇ ▇▇▇▇▇

Position:        CFO

If second signature is required:

Date:             December 15, 2017

Signature:     /s/ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇

Name:           ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇

Position:        SVP, Regional Head, Europe

•

Additional Services means any service specifically qualified as an additional service in any approved ▇▇▇▇▇▇▇▇▇▇ Offer, except all activities involved in converting FOC Material into Product and according to the quality standards set forth in the Quality Agreement including costs of in-process control, quality assurance, quality control and release, deviation and complaint handling, storage of FOC Material until delivery notice, storage of purchased material procured by ▇▇▇▇▇▇▇▇▇▇ and of Product until delivery notice, disposal of waste.

•

Affiliate shall mean with respect to a Party, any person, corporation, company, partnership or other entity that controls, is controlled by, or is under common control with that Party. For the purpose of this definition, “control” shall mean direct ownership of [***] of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or [***] of the equity interest in the case of any other type of legal entity, status as a general partner in any partnership, or any other arrangement whereby the entity or person controls or has the right to control the board of directors or equivalent governing body of a corporation or other entity, or

the ability to cause the direction of the management or policies of a corporation or other entity.

•

BSE shall mean Bovine Spongiform Encephalopathy

•

Business Day shall mean each day of the week save for Saturday, Sunday and public holidays in Germany or Switzerland or the United States of America.

•

Calendar Year shall mean a period of 12 (twelve) consecutive months corresponding to the calendar year commencing on the first day of January.

•

Confidential Information means contents of this Agreement and any information regarding the other Party’s business and / or its Affiliates’ business as well as information relating to the Product disclosed by one Party and / or its Affiliates to the other Party pursuant to this Agreement.

•

Delivery Date means the date of delivery requested by Customer in a Purchase Order.

•

Drug Substance means Customer’s active pharmaceutical ingredient manufactured under GMP condition for human use.

•

DSP stands for downstream processing and describes the process of Drug Substance Manufacturing starting with the filtration of the unprocessed fluid until the formulation of bulk Drug Substance.

•

Equipment means any equipment system to support manufacturing and / or packaging of Customer’s Product.

•

Executive Leadership shall mean for the purpose of this Agreement the Chief Technical Operations Officer of the Customer and the Chief Executive Officer of ▇▇▇▇▇▇▇▇▇▇ respectively (or whoever is on these roles ad interim).

•

Exit Fee shall mean the fee to be paid by the Customer in accordance with the provision of section 2 of Schedule B.

•

Facility shall mean ▇▇▇▇▇▇▇▇▇▇’▇ manufacturing facilities located in Laupheim, Germany.

•

Final Release shall mean Product is quality released by Customer or Customer’s delegate as per the Quality Agreement in Schedule D.

•

FOC (Free of Charge) Material means cell lines and other materials be supplied by Ultragenyx to ▇▇▇▇▇▇▇▇▇▇ free of charge.

•

Force Majeure shall have the meaning as provided in Schedule C, section 8.

•

Good Manufacturing Practices or cGMP means the current good manufacturing practices including EU GMP Guide, 21 CFR, ICH Q7A, 21 CFR, EU guide and their current official interpretations applicable to the manufacturing of drug substances.

•

Hidden Defects means a defect of FOC Material or Product already present at the time of delivery but not detectable at the time of the inspection.

•

Improvement means technical and business process optimization that is beneficial for the manufacturing process, product quality, financial aspect or supply of Customer’s Product.

•

“Intellectual Property Rights” means rights in patents, patent applications (including all utility and design patents and patent applications), inventions, trademarks, service marks, trade names, internet domain names, rights in designs, rights in get-up and trade dress, goodwill and the right to ▇▇▇ for passing off or unfair competition, copyrights, (including all computer applications, programs and other software, including without limitation operating software, network software, firmware, middleware, and design software rights in computer software and databases), database rights, industrial property rights, moral rights of authors, rights to use, and protect the confidentiality of, confidential information (including know-how and trade secrets), utility models, any common law rights arising from use of the foregoing, all rights of renewal, continuations, divisions, extensions and the like relating to the foregoing, and other intellectual property rights, in each case whether registered or unregistered and including any applications and rights to apply for the grant of any such rights and all rights and forms of protection having an equivalent or similar effect anywhere in the world.

•

Joint Working Team Members shall mean the team selected by the Steering Committee in accordance with the criteria set out under section 4.15 of this Agreement.

•

Key Performance Indicators, shall mean a quantifiable measure used to evaluate the performance of ▇▇▇▇▇▇▇▇▇▇ in meeting the objectives of this Agreement as defined by the Joint Working Team and approved by the Steering Committee.

•

Manufacture or Manufacturing means compounding, harvesting, filling or processing, producing, testing and packaging of FOC Material and purchased material to obtain Customer’s Product by ▇▇▇▇▇▇▇▇▇▇ in accordance to the Product specification.

•

Material Change in Control or Business Model shall mean any of the following: (i) the sale or disposition of all or substantially all of the assets of a Party to a Third

Party, (ii) the acquisition by a Third Party, of [***] of a Party’s outstanding shares of voting capital stock (e.g. capital stock entitled to vote generally for the election of directors), or (iii) the merger or consolidation of a Party with or into another corporation. References in this definition to a Third Party shall also include Affiliates in case Affiliate has no comparable financial resources and financial reputation as Customer or ▇▇▇▇▇▇▇▇▇▇ has.

•

Offer shall mean ▇▇▇▇▇▇▇▇▇▇’▇ quotation containing the details of the proposed Services subject to Customer’s binding order.

•

Product shall mean the Drug Substance manufactured by ▇▇▇▇▇▇▇▇▇▇ and to be delivered to Customer.

•

Purchase Order shall mean a firm order placed by Customer issued by Customer with a corresponding purchase order number to ▇▇▇▇▇▇▇▇▇▇ reflecting forecasted Services within the Binding Forecast.

•

TSE shall mean Transmissible Spongiform Encephalopathy.

•

Quality Agreement shall be drafted substantially in the same form as Schedule D.

•

Quarantined Production means a Manufacturing of Product with any material not released by the quality department of ▇▇▇▇▇▇▇▇▇▇ before such Manufacturing. Such Manufacturing requires explicit request by Customer.

•

Quarantined Shipment means a shipment of Product before the quality release by ▇▇▇▇▇▇▇▇▇▇ in accordance with the Quality Agreement.

•

▇▇▇▇▇▇▇▇▇▇ Know-How means all know-how or intellectual property relating to ▇▇▇▇▇▇▇▇▇▇’▇ background know-how in the field of the manufacturing and ▇▇▇▇▇▇▇▇▇▇’▇ operations of drug delivery, medical devices, drug process development services as well as regulatory, packaging and quality issues.

•

▇▇▇▇▇▇▇▇▇▇ Offer means any quote proposed for Additional Services approved by the Customer.

•

Services means all activities related to Manufacturing of Customer’s Product as described in this Agreement and Schedule D which do not include Additional Services.

•

Service Fee means the fee paid by the Customer for each Services as itemized in Schedule B.1 in this Agreement and includes all activities involved in converting FOC Material into Product and according to the quality standards set forth in the Technical Quality Agreement including costs of in-process control, quality

assurance, quality control and release, packaging, storage of FOC Material.Fees for Third Party Materials and Third Party Services are not included and are covered separately.

•

Specifications means the written Product specifications as mutually agreed.

•

Steering Committee shall mean the committee selected by the Parties in accordance with the criteria set out under section 4 of this Agreement.

•

Third Party means any Person other than Customer, ▇▇▇▇▇▇▇▇▇▇ and their respective Affiliates

•

Third Party Material means all materials procured by ▇▇▇▇▇▇▇▇▇▇ for the Manufacturing of the Product.

•

Third Party Services means all services procured by ▇▇▇▇▇▇▇▇▇▇ for the Manufacturing of the Product (e.g. laboratory services, hazardous waste disposal etc.).

•

Technical Release means the release of the Product by ▇▇▇▇▇▇▇▇▇▇ in accordance with Schedule D.

•

Territory shall mean the following countries: EU, USA, Brazil, Mexico, Colombia, Chile, Japan, Turkey or any different country as agreed by the Parties in the Quality Agreement during the term of this Agreement after the Effective Date.

•

USP stands for upstream processing and describes the process of Drug Substance Manufacturing starting from thawing of the cell line until the harvest of the unprocessed fluid.

•

Yield shall mean the amount of Drug Substance manufactured in a production batch, as agreed in writing by the Joint Working Team in compliance with section 4.16 (iii) of the Agreement.

•

1.

Order Processing

2.

Forecast and Purchase Orders

Time period between cancellation and the start date of the USP / DSP reservation

Exit Fee (percentage of the Service Fee applicable to the Product in the cancelled Purchase Order)

[***]

[***]

[***]

[***]

3.

Delivery

3.1

Delivery of FOC Material by Customer.

(i)

a Quarantined Shipment; or

(ii)

a Quarantined Production

3.3

▇▇▇▇▇▇▇▇▇▇ will use their best endeavour to improve constantly the processes and the technology pertaining to the execution of this Agreement. ▇▇▇▇▇▇▇▇▇▇ shall communicate the Improvements to the Steering Committee, who will evaluate in good faith if any mutual benefit may derive from the communicated Improvement.

4.

Key Performance Indicators

5.

Fees

6.

Third Party Services

7.

Third Party Material

8.

Special Costs

9.

Additional Services

(i)

stability Studies of Product;

(ii)

cGMP audits as outlined in Schedule D;

(iii)

inspections of Health Authorities other than EU and FDA;

(iv)

accommodation of “Persons in Plant” ▇▇▇▇▇▇▇▇▇▇ will accommodate and grant reasonable access during working hours for “Person in Plant” at no cost for the Customer. If such an access will exceed [***] Business Days, ▇▇▇▇▇▇▇▇▇▇ will have the right to charge Customer an amount of [***] EUR for any Business Days of access in excess of [***] Business Days.

1.

Scope

2.

Results

2.1

Neither Party shall, as a result of this Agreement, acquire any right, title, or interest in any intellectual property that the other Party owns or controls as of the Effective Date of this Agreement, or that the other Party obtains ownership or control of separately and apart from the performance of the Services under this Agreement ("Background Intellectual Property").

2.2

Customer shall own exclusively all rights, titles, and interests in any and all intellectual property that ▇▇▇▇▇▇▇▇▇▇ conceives, invents, reduces to practice, develops or makes, solely or jointly with Customer, in the course of performance of the Services or as a result of using Customer's Background Intellectual Property.

2.3

Notwithstanding the foregoing, ▇▇▇▇▇▇▇▇▇▇ shall own all rights, titles and interests in any intellectual property regarding Know How that ▇▇▇▇▇▇▇▇▇▇ develops, conceives, invents, reduces to practice or makes in the course of performance of the Services that (i) relates to the ▇▇▇▇▇▇▇▇▇▇ Background Intellectual Property; (ii) ▇▇▇▇▇▇▇▇▇▇’▇ Know How, (iii) which is severable from the Product, and (iii) does not reveal or disclose any Confidential Information of Customer.

3.

Intellectual Property

3.1

For any Inventions both parties shall cooperate in good faith to allocate the rights and the costs which are associated with the possible protection of the Inventions.

3.2

If the performance of the Services and / or Additional Services requires the use of Intellectual Property Rights of ▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ hereby grants to Customer the necessary rights of use to these Intellectual Property Rights solely for the marketing, distribution and sale of the Products. In addition, ▇▇▇▇▇▇▇▇▇▇ grants to Customer the necessary rights of use to these Intellectual Property Rights for the manufacture of the Products by Customer itself of the Products. Such licenses are granted on a worldwide basis, non-exclusively and royalty-free, unless expressly otherwise agreed.

3.3

If the performance of this Agreement requires the use of Intellectual Property Rights of Customer or of third parties, Customer hereby grants to or procures for ▇▇▇▇▇▇▇▇▇▇ the necessary rights of use to these Intellectual Property Rights solely for the performance of the Services and / or Additional Services on a worldwide basis, non-exclusively and free of fees.

3.4

Each Party shall be obliged to acquire the inventions and rights on the inventions made under this Agreement of its employees, consultants, agents and representatives to the extent necessary to secure the other Party’s rights set out in this section 3. Employee invention compensation claims arising under the German Law on Employee Inventions (Gesetz über Arbeitnehmererfindungen / ArbnErfG) and / or comparable legislation as may be applicable in other countries shall be reimbursed by the Party up to [***] EUR, that is exclusively entitled to own such invention, following the allocation of Intellectual Property Right ownership as set out in this Agreement. In case of proposed reimbursements above [***] EUR the Steering Committee shall decide on the respective reimbursement amount.

4.

Defective Product

4.1

IF AND TO THE EXTENT PERMITTED BY LAW, THE PRODUCT IS DELIVERED TO CUSTOMER “AS IS” FOLLOWING COMPLETION OF THE CHECKS DESCRIBED UNDER SECTION 4.2 AND ▇▇▇▇▇▇▇▇▇▇ MAKES NO WARRANTIES, REPRESENTATIONS OR GUARANTEES NOR ANY TERMS AND/OR CONDITIONS OF ANY KIND WHATSOEVER, EITHER EXPRESS OR IMPLIED WHETHER BY STATUTE, COMMON LAW, CUSTOM, COURSE OF DEALING OR OTHERWISE, INCLUDING ANY EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT, FITNESS FOR

A PARTICULAR PURPOSE. FOR THE AVOIDANCE OF ANY DOUBTS THIS PROVISION WILL NOT APPLY TO ANY HIDDEN DEFECTS OF THE PRODUCT.

4.2

Customer shall examine the Product Manufactured and delivered by or on behalf of ▇▇▇▇▇▇▇▇▇▇ for compliance with the Specifications, intactness, shortage, identity or any defect without undue delay. Should any of the Products fail to meet the Specifications, or in the event of any other claim, Customer shall inform ▇▇▇▇▇▇▇▇▇▇ in writing without undue delay, latest within [***] Business Days after receipt of the Product. Hidden Defects can be claimed in writing within [***] Business Days after being detected by Customer. If Customer fails to notify the defect within such period, Customer shall be deemed to have accepted the consignment.

4.3

In the event Customer notifies ▇▇▇▇▇▇▇▇▇▇ within the period mentioned in section. 4.2 above that any of the Products does not conform with the Specifications or is otherwise defective and ▇▇▇▇▇▇▇▇▇▇ agrees with it, ▇▇▇▇▇▇▇▇▇▇ shall conduct its own evaluation within the time frame define in the Quality Technical Agreement and Schedule ▇. ▇▇▇▇▇▇▇▇▇▇ will then repeat the Service free of charge, if Customer agrees to that. This is Customer’s sole and exclusive remedy. If ▇▇▇▇▇▇▇▇▇▇ fails to remedy, ▇▇▇▇▇▇▇▇▇▇ will reimburse Customer for the damages caused by the default up to the limits of liabilities as described in section 5 below. If ▇▇▇▇▇▇▇▇▇▇ pays the compensation, ▇▇▇▇▇▇▇▇▇▇ is no longer obliged to perform the respective concerned Service.

4.4

In the event ▇▇▇▇▇▇▇▇▇▇ disagrees with the results obtained by Customer the issue shall be submitted to an independent testing laboratory, jointly defined by the Steering Committee, whose decision shall be binding on both Parties. The costs of such test shall be borne by the Party found to be at fault.

5.

Indemnification and Limitation of Liability

5.1

The Parties shall indemnify, defend and hold each other and their respective Affiliates, officers, employees and agents harmless from and against any and all losses, costs, damages, fees or expenses, including but not limited to claims on patent infringement and / or infringement of any third party intellectual property rights, as well as product liability claims, complaints or procedures, relating to the Product or otherwise caused by the Services or the Additional Services. (“Losses”) incurred in connection with or arising out of any:

(i)

Third Party claims, demands, suits, proceedings or causes of actions (“Claims”) to the extent arising out of the breach of any Party to provisions of this Agreement;

(ii)

Third Party Claims to the extent arising out of any neglicence or willful misconduct of the Parties in the performance of any obligations under this Agreement.

5.2

All indemnification claims in respect of any person seeking indemnification (collectively the “Indemnitees” and each an “Indemnitee”) under section 5.1 shall be made by the corresponding Party (the “Indemnified Party”). The Indemnified Party shall give to the other Party (the “Indemnifying Party”) prompt written notice (“Indemnification Claim Notice”) of any Losses or the discovery of any fact upon which such Indemnified Party intends to base an indemnification request pursuant to clause 5.1. Each Indemnification Claim Notice must contain a description of the Claim and the nature and the amount of such Loss (to the extent that the nature and the amount are known at such time). Together with the Indemnification Claim Notice, the Indemnified Party shall furnish promptly to the Indemnifying Party copies of all the notices and documents (including court papers) received by any Indemnitee in connection with the Third Party Claim. The Indemnifying Party shall not be obligated to indemnify the Indemnified Party to the extent any admission or statement made by the Indemnified Party materially prejudices the defence of such Third Party Claim. Where required the Indemnifying Party shall promptly send a copy of the Indemnification Claim Notice to its relevant insurers and shall permit them to exercise rights of subrogation.

5.3

At its option the Indemnifying Party may assume control of the defence of any Third Party Claim by giving written notice to the Indemnified Party within [***] Business Days after the Indemnifying Party’s receipt of an Indemnification Claim Notice.

5.4

If the Indemnifying Party chooses not to take control of the defence or prosecute any Third Party Claim, the Indemnified Party shall retain control of the defence thereof, but no Indemnified Party or Indemnitee shall admit any liability with respect to, or settle, compromise or discharge, any such Third Party Claim without the prior written consent of the Indemnifying Party, which consent shall not be unreasonably withheld or delayed.

5.5

▇▇▇▇▇▇▇▇▇▇ excludes any liability for punitive or exemplary damages, recall costs or loss of profit or indirect or consequential damages or damages on Customer Material provided that they do not depend on any wilful misconduct, gross negligence or breach of any provision of this Agreement.

5.6

The Parties overall liability, including the obligation to indemnify, arising out of or in connection with this Agreement, whether in contract or tort, statutory or otherwise is limited to the amount of [***] of the [***]. This limitation does not apply in case of liability arising out of willful misconduct or gross negligence of any of the party including death or personal injury resulting from its negligence, or any liability for fraud, fraudulent misrepresentation or any other liability that cannot be restricted by law.

5.7

If ▇▇▇▇▇▇▇▇▇▇’▇ cooperation is required in administrative procedures, especially in procedures of admission, customs or of importation, Customer indemnifies ▇▇▇▇▇▇▇▇▇▇ from any liability which may arise out of this cooperation. That applies,

in particular, in cases, where ▇▇▇▇▇▇▇▇▇▇, on Customer’s request, makes statements or applications at or towards governmental authorities or where ▇▇▇▇▇▇▇▇▇▇ participates in making those statements or applications.

6.

Insurance

7.

Confidentiality

(i)

the receiving Party already knew, the prior knowledge of which it can document by prior written records;

(ii)

is or becomes public knowledge other than through the receiving Party’s breach of this promise of confidentiality;

(iii)

the receiving Party receives in good faith from a third party not in violation of an obligation of confidentiality or

(iv)

the receiving Party independently develops, discovers or arrives at without use of or reference to the Confidential Information.

8.

Force Majeure

9.

Miscellaneous

1.

Compliance

2.

Anti-Corruption

3.

Export

4.

Dealing with Internal Knowledge, Confidentiality

5.

Data Privacy

6.

Documentation of Business Transactions

7.

Social Responsibility

8.

No Discrimination

9.

EHS (Environmental, Health and Safety)