Exhibit 4.6


 


SIEMENS ID


 


Agreement


 


by and between


 


Profound
Medical Inc.


 


(-
hereinafter referred to as “the Receiver” -)


 


and


 


SIEMENS Healthcare GmbH


 


(-
hereinafter referred to as “SIEMENS” -)


 


- the
Receiver and SIEMENS hereinafter referred to individually 

as “PARTY” or collectively as “PARTIES”
-


 


on the provision of information regarding
SIEMENS’ interface


 




    CONFIDENTIAL


    2 / 26


    

 


Contents


 


	Preamble 	3
	Article 1 - Definitions 	3
	Article 2 - License 	5
	Article 3 - Obligations of the PARTIES 	5
	Article 4 - INTERFACE 	7
	Article 5 - Provision of DEVELOPER SERVICES, INFORMATION and the SDK 	9
	Article 6 - Pricing 	12
	Article 7 - Limitations: Permits, Regulatory Approvals and Standards 	13
	Article 8 - Billing 	16
	Article 9 - Marketing 	17
	Article 10 - Monitoring of Usage Data 	17
	Article 11 - Revocation of the AUTHORIZATION KEY and LICENSE KEY 	17
	Article 12 - Notification Page 	18
	Article 13 - Support 	18
	Article 14 - Liability 	19
	Article 15 - Confidentiality 	20
	Article 16 - Agreement Term, Notification and CHANGE-OF-CONTROL 	21
	Article 17 - Force Majeure 	22
	Article 18 - Miscellaneous 	23
	Article 19 - Arbitration and Substantive Law 	24


 


Annex 1 – Specification of
INFORMATION


Annex 2 – Specification of
PRODUCTS


Annex 3 – Agreement for risks
exported in using Access-i


 




    CONFIDENTIAL


    3 / 26


    

 


Preamble


 


The
PARTIES entered in a co-marketing and co-selling
agreement on February 26, 2016 (the “Original Agreement”).


 


The
PARTIES now wish to substitute and replace the Original Agreement with this Agreement in connection with all sales and other activities
as of the Effective Date, such that all prior financial commitments
and obligations are released and replaced with the financial commitments and obligations of this Agreement.


 


SIEMENS
is prepared to supply certain interface information and/or other documentation to the Receiver to enable the Receiver to use the
Access-I interface for interfacing PRODUCTS to certain SIEMENS
MAGNETOM Scanners pursuant to the terms of this Agreement.


 


The PARTIES therefore agree as follows:


 


Article
1 - Definitions


 


		1.1	INFORMATION hereinafter refers to know-how,
information and/or documentation supplied by SIEMENS to the Receiver as
detailed in Annex 1.



 


		1.2	PRODUCTS hereinafter refer to Receiver’s products developed for the ablation of soft tissue
in conjunction with MRI scanners.



 


		1.3	SIEMENS MAGNETOM SCANNERS hereinafter
refer to certain SIEMENS MAGNETOM Scanners which the Receiver intends to interface to its PRODUCTS using the INFORMATION and
which are equipped with the INTERFACE.



 


		1.4	CHANGE OF CONTROL hereinafter means, with
respect to the Receiver, one of the following events or series
of related events: a) a sale of all or substantially all of the Receiver’s assets, voting stock or securities or business
relating to this Agreement; b) a merger, reorganization or consolidation
involving the Receiver in which the stockholders of the Receiver immediately prior to such transaction cease to own collectively
a majority of the voting equity securities of the successor entity; or c) a person or group of persons acting in concert acquire
fifty percent (50%) or more of the voting equity securities of
the Receiver.



 


		1.5	AFFILIATE shall mean, with
respect to a PARTY, a subsidiary, meaning
a company in which such PARTY owns or controls, directly or indirectly, more
than fifty percent (50%) of the stock or voting rights,
or a parent company, meaning
a company which owns or controls, directly or indirectly,
more than fifty percent (50%)
of the stock or voting rights of the relevant PARTY, or a company
which is a subsidiary of such PARTY’s parent company.



 




    CONFIDENTIAL


    4 / 26


    

 


		1.6	COMPETITOR hereinafter refers to any entity
which has a product line that competes with SIEMENS MAGNETOM SCANNERS.



 


		1.7	END USER hereinafter refers to an individual,
company, institution
or other legal entity other than the PARTIES or an AFFILIATE of SIEMENS that uses or intends to use the PRODUCTS in combination
with a SIEMENS MAGNETOM SCANNER to treat patients or to conduct any form of research.



 


		1.8	OTHERS hereinafter refers to any individual,
company, institution
or other legal entity other than the PARTIES or any AFFILIATE of either of the PARTIES or END USERS.



 


		1.9	IP hereinafter refers to intellectual
property, which is patents, rights
to inventions, copyright and related rights, trademarks, trade names and domain names, rights to sue for passing off, rights in
designs, rights in computer software, database rights, rights in
confidential information (including know-how and trade secrets)
and any other equivalent intellectual property rights, in each
case whether registered or unregistered and including all applications (or rights to apply) for, and renewals or extensions
of, such rights or and all similar or equivalent rights or forms
of protection which subsist now or in the future, in any part of
the world.



 


		1.10	INTERFACE hereinafter refers to the Access-i
(Scanner Remote Control) Interface for 3rd party device integration developed and provided through SIEMENS.



 


		1.11	DEVELOPER SERVICES hereinafter refers
to the activities conducted by SIEMENS to support the development efforts of the Receiver to achieve compatibility of the Receiver’s
PRODUCTS with the INTERFACE; this does not include any other development efforts in the Receiver’s PRODUCTS.



 


		1.12	SOFTWARE DEVELOPER KIT (SDK) hereinafter
refers to a software tool developed and provided through SIEMENS to support the development efforts of the Receiver to achieve
compatibility of the Receiver’s PRODUCTS with the INTERFACE.



 


		1.13	AUTHORIZATION KEY hereinafter refers to
an authorization key file installed on the Receiver’s PRODUCTS enabling the use of the PRODUCTS in connection with the INTERFACE
by End Users. The AUTHORIZATION KEY is time limited and unique to each individual MAGNETOM SCANNER.



 


		1.14	LICENSE KEY hereinafter refers to a software
license and license key file installed on the SIEMENS MAGNETOM SCANNERS enabling the INTERFACE on SIEMENS MAGNETOM SCANNERS.
The LICENSE KEY has to be purchased by the END USER (at no additional
cost to Receiver) from Siemens as a one-time purchase. The
provision and the cost of this LICENSE KEY are not covered by this agreement.



 


		1.15	EFFECTIVE DATE hereinafter means January
21st, 2019.



 




    CONFIDENTIAL


    5 / 26


    

 


Article
2 - License


 


		2.1	Subject to the terms and conditions set
out in this Agreement, SIEMENS shall make available and provide
to the Receiver (and its personnel and subcontractors) the INFORMATION, DEVELOPER
SERVICES, the SDK and the AUTHORIZATION KEY and herewith grants
to the Receiver under this Agreement the following rights:



 


		2.2	A non-exclusive,
non-transferable, worldwide
right and license to use the INFORMATION, DEVELOPER SERVICES,
the SDK and the AUTHORIZATION KEY for the sole purpose of interfacing
PRODUCTS to certain SIEMENS MAGNETOM SCANNERS and to make available and deliver such adapted PRODUCTS for use by END USERS for
use in connection with SIEMENS MAGNETOM SCANNERS for research and/or development purposes and/or for medical treatment.
The license granted herein includes the right to grant sublicenses to
Receiver’s AFFILIATES and service providers to Profound carrying out Profounds business and shall exclusively apply to the
Receiver’s PRODUCTS and any successor product to the Receiver’s PRODUCTS which replaces the PRODUCT in question,
but not cover any other product of the Receiver. Receiver will not reverse
engineer the SDK, the INTERFACE or the AUTHORIZATION KEY for the
purpose of the development of adaptations of the Receiver’s PRODUCTS to any other customer other than SIEMENS customers.



 


Notwithstanding
the above, nothing in this Agreement shall limit the Receiver from
developing PRODUCTS that can interface with scanners from multiple suppliers (i.e. that can interface with both SIEMENS MAGNETOM
SCANNERS and scanners from other manufacturers) as long as Receiver does not use or disclose to such other manufacturers any CONFIDENTIAL
INFORMATION provided to the Receiver under this Agreement in the development of interfaces for such other manufacturers’
scanners.


 


Article
3 - Obligations of the PARTIES


 


		3.1	Obligations
of SIEMENS:



 


		3.1.1	SIEMENS will provide the Receiver with
information on the related product risks as referred to in Annex 3 and inform the Receiver of any updates during the lifetime of
the INTERFACE.



 


		3.1.2	SIEMENS will provide the Receiver with
AUTHORIZATION KEYS on a perpetual basis for each individual SIEMENS MAGNETOM SCANNER enabling the use of the INTERFACE according
to the INTERFACE description.



 


		3.1.3	SIEMENS will provide the END USER with
the LICENSE KEY to enable use of the SDK with the INTERFACE.



 




    CONFIDENTIAL


    6 / 26


    

 


		3.1.4	SIEMENS will use commercially reasonable
efforts to notify the Receiver of any actual or planned change regarding the INTERFACE that might compromise the compatible use
of the Receivers PRODUCTS with the SIEMENS INTERFACE, and to provide
the Receiver with such INFORMATION and/or collaborative testing as may be reasonably required in order for the Receiver to sufficiently
maintain or update the Receiver’s PRODUCTS and, if applicable,
the Technical Documentation and/or clinical dossier of such PRODUCTS in
accordance with Directive 93/42/EEC or Regulation (EU) 2017/745 on medical devices, as applicable, to
ensure continued compatible use with the INTERFACE in view of such change no less than 120 days
in advance of the time at which the change becomes effective for End Users SIEMENS MAGNETOM SCANNERs. More generally Siemens
will aid reasonable requests to support the attainment of data for validation runs, compatibility
testing and other such assistance; however the determination of reasonable will be at Siemens discreation.



 


		3.1.5	SIEMENS will use commercially reasonable
efforts to provide the DEVELOPER SERVICES and the SDK to the Receiver.



 


		3.1.6	SIEMENS shall not have any other obligations
than those expressly described in this Agreement. For the sake
of clarity, SIEMENS shall not be obligated to disclose any further
information than the INFORMATION described in Annex 1.



 


		3.2	Obligations
of the Receiver:



 


		3.2.1	The Receiver acknowledges and agrees that
the AUTHORIZATION KEY enables the use of the INTERFACE according to the INTERFACE description and that its improper use could cause
damage to the system and patient injury. It is the responsibility
of the Receiver to comply with all applicable legal requirements related to the PRODUCTS, to understand all consequences of using
the PRODUCTS or the INTERFACE on the basis of the INFORMATION provided by SIEMENS in Annex 1 and the product risk information provided
in Annex 3, and to refrain from such use if there is any reasonable
question of legality, hardware or other property damage, or patient
injury.



 


		3.2.2	If
the use of the INTERFACE is for the purpose of research conducted or sponsored by the Receiver involving human subjects,
it requires appropriate documentation, review
and approval by an appropriate Ethics Committee or by the Receiver’s Institutional Review Board (“IRB”) according
to applicable medical device law and compliance with all Ethics Committee/IRB recommendations and requirements. No human subject
research may be commenced by Receiver or a party sponsored by Receiver before Ethics Committee/IRB approval has been granted.



 


		3.2.3	The Receiver accepts the exported product
risks described in Annex 3 to this contract and any risks as updated by SIEMENS according to Article 3.1.1.
It is the responsibility of the Receiver to assess the measures defined
in Annex 3 within their processes and to ensure that reasonable measures are in place to mitigate these risks in using the
INTERFACE’s functionality.



 




    CONFIDENTIAL


    7 / 26


    

 


		3.2.4	For the issuance of an AUTHORIZATION KEY,
the Receiver has to provide to SIEMENS the serial number of the SIEMENS
MAGNETOM SCANNER the PRODUCT will be interfaced with and the duration the PRODUCT is intended to be compatible with the SIEMENS
MAGNETOM SCANNER, whereas AUTHORIZATION KEYS can be deactivated
on request



 


		3.2.5	The AUTHORIZATION KEY mentioned in Article
3.1.2 (and any other information provided by SIEMENS) shall be
(i) used by the Receiver exclusively to use the INTERFACE for interfacing PRODUCTS to certain SIEMENS MAGNETOM SCANNERS,
unless otherwise expressly agreed to in writing by SIEMENS and (ii)
kept strictly confidential and encrypted or in some secure fashion by the Receiver with the same degree of care as is used with
respect to the Receiver’s own equally important confidential information to avoid disclosure to any third party, but
at least with reasonable care. Without limiting use of the PRODUCTS
by END USERS the AUTHORIZATION KEY shall not be made available to OTHERs and shall be made available to AFFILIATES, Receiver’s
personnel, contractors for the sole purpose of interfacing and
using the PRODUCTS with the dedicated SIEMENS MAGNETOM SCANNER according to the terms and conditions of this Agreement.



 


		3.2.6	The Receiver has the sole responsibility
for the combined products and it is the Receiver’s responsibility to ensure that all legal and country specific requirements
for such a combination are adhered to, following the obligations
of the country in which the combination is used. This includes,
for example, that no unacceptable risks can be caused by the combination to patients or users. SIEMENS takes no responsibility
regarding the combination of the products even though SIEMENS supports the connectivity to the INTERFACE; provided that any damage
occurred, if any, was
not caused by a gross negligent act or omission of SIEMENS.



 


Article
4 - INTERFACE


 


		4.1	Update Cycles



 


SIEMENS
is prepared to continuously develop new functionalities and features for the INTERFACE at no additional cost to Receiver. Such
new features and functionalities are intended to be released in up to two application updates per year in accordance with Section
3.1.4.
Security related updates and patches can be introduced whenever deemed necessary by SIEMENS. SIEMENS
will use commercially reasonable efforts to maintain the compatibility
of the PRODUCT with the SIEMENS MAGNETOM SCANNER and provide all necessary information and assistance to Receiver as outlined
in Section 3.1.4.


 




    CONFIDENTIAL


    8 / 26


    

 


		4.2	Changes to Requirements



 


SIEMENS
may change and/or issue additional technical requirements for the combination of the PRODUCT with the SIEMENS MAGNETOM SCANNER
using the INTERFACE at any time by using commercially reasonable efforts to notifying the Receiver at SIEMENS’ earliest
convenience, but no less than 120 days
before the changed technical requirements become effective, provided that SIEMENS will endeavor to maintain compatibility of the
INTERFACE with any of the Receiver’s PRODUCTS compliant with the requirements at the time of their submission during next
two (2) update cycles of the INTERFACE following the submission of the respective PRODUCT at minimum. Notwithstanding
the foregoing, the Receiver has to ensure that the combination
of its PRODUCTS to the SIEMENS MAGNETOM SCANNER is still working with the changes in the requirement and SIEMENS shall provide
all necessary information and assistance in this respect, as outlined
in Section 3.1.4. Such notice period may be shortened by SIEMENS,
and the requirements regarding maintenance of compatibility will not apply
only to the extent that, based on SIEMENS’ reasonable judgment,
SIEMENS believes that a shorter notice period or incompatibility is
necessary in order to avoid any: (i) threat to the security or functionality of the INTERFACE or the DEVELOPER SERVICES; (ii) adverse
impact on the Receiver, SIEMENS, the
Receiver’s or SIEMENS’ AFFILIATES, END USERS,
or any third party, including,
without limitation, any risk of personal injury; and/or (iii) subject the Receiver, SIEMENS, the
Receiver’s or SIEMENS’ AFFILIATES, END USERS,
or any third party to material liability for personal injury or IP infringement;
in each case, so long as SIEMENS takes commercially reasonable efforts to maintain the compatibility of the PRODUCT with the SIEMENS
MAGNETOM SCANNER. To the extent the Receiver is, due
to such changes, materially deprived of the benefits of the INTERFACE or the SDK, the Receiver is entitled to terminate the Agreement
in writing with effect upon effectiveness of the change at the earliest and the Receiver will be entitled to a refund of all amounts
paid with regards to the affected AUTHORIZATION KEYs by Receiver to SIEMENS over the period of incompatability.


 


		4.3	Changes to the INTERFACE



 


SIEMENS
updates and further develops the technology, features and functionalities of the INTERFACE and is under no obligation to maintain
prior versions thereof. Upon the provision of a modified or new version of the INTERFACE, the Receiver is no longer entitled to
use previous versions. Should material changes to the INTERFACE be implemented which have an impact on the Receiver’s use,
whereas these impacts are known to SIEMENS, or should agreed functionalities be restricted or disabled, SIEMENS will use commercially
reasonable efforts to notify the Receiver at SIEMENS’ earliest convenience, but no less than 120 days before the changes
become effective. Such notice period may be shortened by SIEMENS only to the extent that, based on SIEMENS’ reasonable judgment,
SIEMENS believes that a shorter notice period is necessary in order to avoid any: (i) threat to the security or functionality
of the INTERFACE; (ii) adverse impact on the Receiver, SIEMENS, the Receiver’s or SIEMENS’ Affiliates, END USERS,
or any third party, including, without limitation, any risk of personal injury; and/or (iii) subject the Receiver, SIEMENS,
the Receiver’s or SIEMENS’ Affiliates, END
USERS, or any third party to material liability for personal injury
or IP infringement; in each case, so long as SIEMENS takes commercially
reasonable efforts to maintain the compatibility of the PRODUCT with the SIEMENS MAGNETOM SCANNER. To
the extent the Receiver is, due to such changes, materially deprived of the benefits of the INTERFACE, the
Receiver is entitled to terminate the Agreement in writing with effect upon effectiveness of the change at the earliest and Receiver
will be entitled to a refund of all amounts with regards to the affected AUTHORIZATION KEYs paid by Receiver to SIEMENS over the
period of incompatability.


 




    CONFIDENTIAL


    9 / 26


    

  


		4.4	Freedom from Defects in Title



 


SIEMENS
represents, warrants and covenants that during the term of this Agreement, the
Receiver’s use of the INTERFACE as permitted under the Agreement does not infringe upon a patent, copyright, trade secret,
or other intellectual property right in or to such INTERFACE in the country
where SIEMENS has its seat or in countries where SIEMENS have put SIEMENS MAGNETOM SCANNERS on the market. The
Receiver acknowledges that SIEMENS and/or its AFFILIATES is not responsible for an infringement of any such intellectual property
rights to the extent it is due to: (i) the Receiver’s failure to use the most current version of or a defect correction or
patch supplied by SIEMENS; (ii) the combination, operation,
or use of the INTERFACE in conjunction with any non-SIEMENS information
or with any third-party software, equipment, materials,
or products other than as contemplated by the INFORMATION; or (iii) an adjustment or configuration of the INTERFACE not made by
SIEMENS (or on its behalf). Notwithstanding any deviating and/or
additional obligations expressly set forth in the Agreement, SIEMENS will neither assume any additional obligation nor responsibility
that Receiver’s use of the INTERFACE complies with applicable law.


 


Article
5 - Provision of DEVELOPER SERVICES, INFORMATION
and the SDK


 


		5.1	Service Standards



 


During
the term of the Agreement and subject to Article 5.2 to Article
5.4, SIEMENS
will provide DEVELOPER SERVICES as a service in conformance with the features and functionalities as described in the Agreement
and the INFORMATION. SIEMENS will provide the Receiver with information
and make the SDK available in a manner suitable for adapting the Receiver’s PRODUCTS to the INTERFACE. This
service will include providing:


 




    CONFIDENTIAL


    10 / 26


    

 


		·	Technical descriptions



		·	SDK including



		o	INTERFACE Simulator



		o	Test Client for the INTERFACE



		·	Library of examples to demonstrate programming
and/ or usage of certain functionalities



		·	Introductory webinar support/ conference
call (up to one hour)



		·	Email support to answer basic questions



		·	Up to two follow-up
conference calls to discuss questions (up to one hour each)



		·	One introduction call for each regular
update (up to one hour)



 


The
service does not include code check or any development work, neither
software nor hardware related.


 


		5.2	Limitations



 


Except as set forth in the
Agreement:


 


(a)
SIEMENS assumes no obligations to the Receiver in connection with, and
any statements about the INTERFACE, the DEVELOPER SERVICES,
the SDK and the INFORMATION. It
does constitute merely technical information and not obligations of SIEMENS.


 


(b) None of the PARTIES’
obligations under the Agreement shall be deemed to constitute a guaranteed quality (zugesicherte Eigenschaft) or other guarantee
(Garantie); and


 


(c)
Each of the PARTIES disclaims any strict liability (verschuldensunabhängige Haftung) for defects and non-conformance already
existing when the Agreement was concluded.


 




    CONFIDENTIAL


    11 / 26


    

 


		5.3	Changes to DEVELOPER SERVICES



 


Unless
expressly agreed otherwise, SIEMENS provides the DEVELOPER SERVICES and the SDK as standard services and enables the Receiver
to use the agreed DEVELOPER SERVICES and the SDK made generally available by SIEMENS to its other receivers. SIEMENS will update
and further develop the technology, features and functionalities
of the DEVELOPER SERVICES and the SDK and is under no obligation to maintain prior versions thereof. Upon
the provision of a modified or new version of the DEVELOPER SERVICES and the SDK or any other content, the
Receiver is no longer entitled to use previous versions. Should material changes to the DEVELOPER SERVICES or the SDK be implemented
which have an impact on the Receivers use or should agreed DEVELOPER SERVICES or SDK functionalities be restricted or disabled,
SIEMENS will notify the Receiver at least one hundred eighty (180) days before the changes become effective. Such
notice period may be shortened only to the extent that, based on
SIEMENS reasonable judgment, SIEMENS believes that changes are
necessary in order to avoid any: (i) threat to the security or functionality of the INTERFACE or the DEVELOPER SERVICES or the
SDK; (ii) adverse impact on the Receiver, SIEMENS, the Receiver’s
or SIEMENS’ Affiliates, END USERS, or any third party,
including, without
limitation, any risk of personal injury; and/or (iii) subject the
Receiver, SIEMENS, the Receiver’s or SIEMENS’ Affiliates,
END USERS, or any third party to material liability for personal
injury or IP infringement; in each case, so long as SIEMENS takes
commercially reasonable efforts to maintain the compatibility of the PRODUCT with the SIEMENS MAGNETOM SCANNER. To
the extent the Receiver is, due to such changes, materially deprived
of the benefits of the DEVELOPER SERVICES or SDK, the Receiver
is entitled to terminate the Agreement in writing with effect upon effectiveness of the change at the earliest and Receiver will
be entitled to a refund of all amounts paid by Receiver with regards to the affected AUTHORIZATION KEYs to SIEMENS over the period
of incompatability.


 


		5.4	Discontinuation of Services



 


SIEMENS
may discontinue the provision of DEVELOPER SERVICES or the SDK in relation to a PRODUCT for use by an END USER at any time if the
respective AUTHORIZATION KEY or LICENSE KEY has been revoked by SIEMENS according to Article 11 - Suspension
of the AUTHORIZATION KEY and LICENSE KEY or the Agreement has been terminated according to Article16.2.


 


		5.5	Place of Performance



 


SIEMENS
provides the Receiver access to the DEVELOPER SERVICES and the SDK to be provided over the internet at the WAN exit of the data
center used by SIEMENS. Unless otherwise agreed, SIEMENS
will use a data center in Germany to provide the DEVELOPER SERVICES and the SDK. SIEMENS
reserves the right to change the data center location and use additional data centers at any time and will inform the Receiver
of this in due time, provided that any such data centers will be
within the European Union. SIEMENS will ensure that AUTHORIZATION
KEYS are generated, transferred, and/or revoked from the SIEMENS
Headquarter only.


 




    CONFIDENTIAL


    12 / 26


    

 


		5.6	Freedom from Defects in Title



 


SIEMENS
represents, warrants and covenants that during the term of this
Agreement, the Receiver’s use of the DEVELOPER SERVICES and SDK as permitted under the Agreement does not infringe upon a
patent, copyright, trade secret, or
other intellectual property right in or to such DEVELOPER SERVICES and SDK in the country where SIEMENS has its seat or in countries
where SIEMENS have put SIEMENS MAGNETOM SCANNERS on the market. The
Receiver acknowledges that SIEMENS and/or its AFFILIATES is not responsible for an infringement of any such intellectual property
rights to the extent it is due to: (i) the Receiver’s failure to use the most current version of or a defect correction
or patch supplied by SIEMENS for DEVELOPER SERVICES or the SDK; (ii) the combination, operation,
or use of the DEVELOPER SERVICES or the SDK in conjunction with any non-SIEMENS
information or with any third-party software, equipment, materials,
or products other than as contemplated by the INFORMATION; or (iii) an adjustment or configuration of the DEVELOPER SERVICES
or SDK not made by SIEMENS (or on its behalf). Notwithstanding any deviating and/or additional obligations expressly set forth
in the Agreement, SIEMENS will neither assume any additional obligation
nor responsibility that Receiver’s use of the DEVELOPER SERVICES or the SDK comply with applicable law.


 


Article
6 - Pricing


 


		6.1	As consideration that SIEMENS fulfills
the described obligations and provides the described support the PARTIES agree upon a one-time
fixed license fee of $100,000 USD to be paid to SIEMENS.



 


		6.2	SIEMENS shall be entitled to invoice the
Receiver the one-time fixed license fee ten (10)
days after the effective date.



 


		6.3	As consideration for the licenses granted under this Agreement the PARTIES agree upon a yearly
license fee calculated based on the number of SIEMENS MAGNETOM SCANNERS being used for patient treatment:



 


		•	[pricing information redacted]
USD per scanner per year for the first 10 connected SIEMENS MAGNETOM
SCANNERS (Scanner 1 – 10)



 


		•	[pricing information redacted]
USD per scanner per year for additional 20 connected SIEMENS MAGNETOM
SCANNERS (Scanner 11 – 30)



 


		•	[pricing information redacted] USD per scanner per year for additional 70 connected SIEMENS
MAGNETOM SCANNERS (Scanner 31 – 100)



 


		•	[pricing information redacted]
USD per scanner for additional SIEMENS MAGNETOM SCANNERS exceeding 100.



 


The
yearly license fee shall be prorated based on the number of days that elapsed during the year during which the SIEMENS MAGNETOM
SCANNERS are in use during the applicable year. There shall be
no yearly license fees due in respect of SIEMENS MAGNETOM SCANNERS which are already in use as of the Effective Date until the
beginning of the second year of this Agreement.


 




    CONFIDENTIAL


    13 / 26


    

 


Any
SIEMENS MAGNETOM SCANNERS which are in any year used solely for the purpose of pre-clinical
or clinical research, whereas the Receiver is not getting any revenue from the END USER, will
not be subject to any license fees. Receiver will advise SIEMENS
of the specific SIEMENS MAGNETOM SCANNERS being used solely for pre-clinical or clinical research and, upon
request, Receiver will provide an annual attestation as to the
number and location of any such SIEMENS MAGNETOM SCANNERS.


 


Article
7 - Limitations: Permits, Regulatory Approvals and Standards


 


		7.1	The
Receiver acknowledges and agrees that:



 


		7.1.1	Operation of SIEMENS MAGNETOM SCANNERS
demands observance of the applicable statutory provisions (e.g.,
in the EU, Directive
93/42/EEC on medical devices (“MDD”) and Regulation (EU) 2017/745 on medical devices (“MDR”), to become
fully applicable on 26 May 2020) or any future revisions / successor
requirements and is limited to particular indicated uses.



 


		7.1.2	Any changes to SIEMENS MAGNETOM SCANNERS
by the Receiver, its AFFILIATES or OTHERS are not covered by CE labeling or regulatory approval or other applicable statutory provisions
and can be relevant for patient safety.



 


		7.1.3	As part of the INFORMATION, SIEMENS
shall only provide the documentation outlined in Annex 1 and does not foresee providing customized documentation, in particular
not any part of the END USER documentation for the PRODUCTS and the combination of the PRODUCTS to the SIEMENS MAGNETOM SCANNER.
Upon Receiver’s request, SIEMENS shall however provide reasonable
assistance and information needed for testing and documenting such combination as related to the INTERFACE only and not for MR
compatability in general. However, more generally Siemens will aid reasonable requests to support the attainment of data for validation
runs, compatibility testing and other such assistance; however the determination of reasonable will be at Siemens discreation.



 


		7.1.4	SIEMENS does not assume any responsibility
for the proper or safe functioning of the Receiver’s PRODUCTS and/or its combination with SIEMENS MAGNETOM SCANNERS.
The Receiver will remain fully responsible for their PRODUCTS including
the combination with the SIEMENS MAGNETOM SCANNER, and the manufacture,
sale, marketing and service of the PRODUCTS. SIEMENS
however endeavors to provide complete and accurate INFORMATION.



 




    CONFIDENTIAL


    14 / 26


    

 


		7.1.5	SIEMENS is not responsible for an infringement
of any third party intellectual property rights due to: (i) The Receiver’s failure to use the most current version of or
a defect correction or patch supplied by SIEMENS for the DEVELOPER SERVICES, the
SDK or the INTERFACE; (ii) the combination, operation, or
use of the DEVELOPER SERVICES; the SDK or the INTERFACE in conjunction with any Receiver content or with any third-party
software, equipment, materials,
or products; or (iii) an adjustment or configuration of the DEVELOPER SERVICES; the SDK or the INTERFACE not made by, or
on behalf of, SIEMENS or its AFFILIATES (or as contemplated by Section 7.1.7);
provided always that the DEVELOPER SERVICES, SDK or the INTERFACE
as supplied by SIEMENS are not the root cause for such infringement. Notwithstanding
any deviating and/or additional obligations expressly set forth in the Agreement, SIEMENS will neither assume any additional obligation
nor responsibility that the DEVELOPER SERVICES, the SDK or the
INTERFACE and/or the Receiver’s use of the DEVELOPER SERVICES, the SDK or the INTERFACE comply with applicable law.



 


		7.1.6	This Agreement does not cover service
related issues for either party at the Receiver’s site or at the END USER’s site and SIEMENS is not responsible for
any service or support related to the Receiver’s PRODUCTS and the combination of the PRODUCTS to the SIEMENS MAGNETOM SCANNER
unless otherwise agreed upon in writing.



 


		7.1.7	SIEMENS may engage any of its AFFILIATES
and any other business partners for and in connection with the provision of DEVELOPER SERVICES, the
AUTHORIZATION KEY, INTERFACE, billing
or payment. The Receiver agrees to provide all reasonable cooperation
required by SIEMENS should it become necessary or desirable, in
SIEMENS’ sole discretion, for SIEMENS to use a new or different
service providers. SIEMENS will be responsible for any of its obligations hereunder which are performed by its AFFILIATES,
business partners and other service providers.



 


		7.1.8	The Receiver may, without
accounting to SIEMENS, use and modify information and documentation
in order to generate its END USER documentation of the PRODUCTS and the combination of the PRODUCTS to the SIEMENS MAGNETOM SCANNER,
provided this is done:



 


		•	at the Receiver’s own cost, responsibility and risk,



		•	ensuring that the documentation conforms
to the regulations applicable in the target countries and continuously updating it to the newest revision level, in
particular as such information and documentation provided by SIEMENS may be country or region-specific
and subject to change,



		•	without in any way portraying SIEMENS
as responsible for the content of the END USER documentation, and
clearly identifying the Receiver as responsible for marketing, sale,
market-observation
and service, subject to customary disclaimers and limitation on liability.



 




    CONFIDENTIAL


    15 / 26


    

  


	 	7.2	The
                                         Receiver agrees to:
	 	 	 
		7.2.1	Generate
                                         and provide all END USER documentation.



 


		7.2.2	Complete risk assessments, risk mitigation,
integration and system testing, compatibility
testing, etc. for their PRODUCTS and comply with all applicable
statutory provisions and regulations (e.g. those
stipulated by the FDA or the European Commission or Japanese equivalent regulatory bodies) of the target country in which the combined
product will be operated before releasing the PRODUCT into the market. Upon
SIEMENS discretion which will not be unreasonably withheld, SIEMENS
will use commercially reasonable efforts to provide standard documentation and reasonable support in connection with such activities
upon request.



 


		7.2.3	Ensure that the Receiver’s END-USER’s
are provided with all reasonably relevant instructions, warnings and, if
required, training for the Receiver’s PRODUCTS and its combination
with the SIEMENS MAGNETOM SCANNERS, particularly if these are safety-relevant.



 


		7.2.4	The Receiver is responsible for post market
surveillance (as required by applicable laws and regulations where Receiver’s PRODUCTS are approved and in use) of their
PRODUCTS and the combination of their PRODUCTS with SIEMENS MAGENTOM SCANNERS.



 


Furthermore,
the Receiver has the responsibility for the proper handling and, in case of adverse events, reporting to regulatory bodies customer
complaints related to the combination of their PRODUCTS to the SIEMENS MAGNETOM SCANNERS (as required by applicable laws and regulations
where Receiver’s PRODUCTS are approved and in use).


 


The
Receiver has the obligation to inform SIEMENS without undue delay about material adverse events in relation to the combination
of their PRODUCTS and the SIEMENS MAGNETOM SCANNER to the best of the Receiver’s knowledge.


 


The Receiver has the responsibility
to perform field updates and recalls, if necessary conduct reporting to reduce a risk to health and bring back the combination
into specification.


 


SIEMENS will not take any responsibility
related to post market surveillance / vigilance of the combination of the Receiver’s PRODUCTS with the SIEMENS MAGNETOM
SCANNERS other than as set out in Section 4.


 


		7.3	The Receiver shall indemnify, defend
and hold harmless SIEMENS and its AFFILIATES from any and all proceedings, costs,
expenses, damages, fees, penalties, and losses (including reasonable attorney fees), in
each case arising from a third party claim, that result from:



 




    CONFIDENTIAL


    16 / 26


    

 


		7.3.1	A culpable breach of an obligation under this Agreement by the Receiver, Receiver’s AFFILIATES
and their respective employees and agents; and



 


		7.3.2	failures of the SIEMENS MAGNETOM SCANNERS
to function in accordance with their INFORMATION to the extent caused by the combination of the Receiver’s PRODUCTS with
SIEMENS MAGNETOM SCANNERS.



 


		7.4	SIEMENS shall indemnify, defend
and hold harmless Receiver and its AFFILIATES from any and all proceedings, costs,
expenses, damages, fees, penalties, and losses (including reasonable
attorney fees), in each case arising from a third party claim,
that result from:



 


		7.4.1	A non-fulfillment,
wrongful act or omission or a culpable breach of an obligation under this
Agreement by SIEMENS, SIEMENS AFFILIATES and their respective employees
and agents; and



 


		7.4.2	failures of the SIEMENS MAGNETOM SCANNERS,
the INTERFACE, or
the SDK to function in accordance with their INFORMATION to the extent they are not caused by the combination of the Receiver’s
PRODUCTS with SIEMENS MAGNETOM SCANNERS, the INTERFACE,
or the SDK; and



 


		7.4.3	a claim that the SIEMENS MAGNETOM SCANNERS,
the INTERFACE, or
the SDK infringe or misappropriate an OTHER’s IP other than where such infringement or misappropriation would not have occurred
but for the combination of the SIEMENS MAGNETOM SCANNERS, the INTERFACE,
or the SDK with the PRODUCT.



 


Article
8 - Billing


 


The
services and responsibilities described under this Agreement make SIEMENS eligible to receive a yearly license fee calculated as
outlined in Article 6.3. The
invoices will refer to an applicable timeframe. Receiver will pay
all properly invoiced amounts within 30 days of its receipt of
the applicable invoice.


 


The
license fee will be paid in US currency to SIEMENS or its respective AFFILIATES. Each
PARTY will ensure that its AFFILIATES adopt and comply with the provisions of this Agreement applicable to such transactions to
the extent allowed under local law.


 


Within
thirty (30) business days after the end of each calendar quarter, SIEMENS
will invoice the Receiver the license fee for the applicable quarter as defined in Article 6 - Pricing
based on all connected SIEMENS MAGNETOM SCANNERS and based on the analysis of the received customer data; the number of issued
AUTHORIZATION KEYS and the resulting license fee and prorated for the applicable portion of the quarter.


 




    CONFIDENTIAL


    17 / 26


    

 


lf
the Receiver is required by law to make any deduction or to withhold from any sum payable directly to SIEMENS or any of its AFFILIATES
hereunder, the Receiver shall promptly effect payment thereof to
the applicable tax authorities, and shall also promptly provide SIEMENS or any of its AFFILIATES with official tax receipts or
other evidence sufficient to establish that the taxes have been paid and to enable SIEMENS or any of its AFFILIATES to support
a claim for income tax credits for such payments. Failure to provide official tax receipts or other evidence of payment shall
result in the Receiver paying directly to SIEMENS or any of its AFFILIATES such amounts deducted or withheld from the original
payment. The Receiver shall also assist SIEMENS or any of its AFFILIATES in minimizing the withholding rate available under an
applicable tax treaty, or otherwise, by supplying SIEMENS or any
of its AFFILIATES with any appropriate documentation upon reasonable request.


 


Article
9 - Marketing


 


SIEMENS
may, but is not obligated to, advertise
the PRODUCTS offered by the Receiver. For this purpose, the Receiver grants SIEMENS a non-exclusive,
non-transferable,
sub-licensable,
and royalty-free worldwide license to use all trademarks or trade
names of the Receiver’s PRODUCTS.


 


RECEIVER
may, but is not obligated to, advertise the combination of SIEMENS
MAGNETOM SCANNERS and the Receiver’s PRODUCTS.


 


All
such advertising materials created by either PARTY using any trademark or trade names of the other PARTY will be subject to prior
approval, not to be unreasonably withheld or delayed.


 


The
PARTIES will discuss in good faith the possibilities for a joint marketing collaboration between the PARTIES, aiming
towards each of the PARTIES being able to market a joint offering of the PRODUCTS together with SIEMENS MAGNETOM SCANNERS.
Any such expanded collaboration shall be agreed upon separately between
the PARTIES.


 


Article 10 - Monitoring of Usage Data


 


SIEMENS
may and will use reasonable efforts to monitor the usage of the INTERFACE by END USERS, e.g.,
the number of users, for SIEMENS’ internal business purposes,
in particular: (i) for security and availability reasons; (ii) to the extent required to ensure compliance of the END USER with
the applicable END USER agreement and of the Receiver with this Agreement; and (iii) to detect, prevent,
and suspend any use of the INTERFACE exceeding the permitted use under the END USER agreement as well as this Agreement,
to charge for such excess use, and otherwise as necessary for payment
and billing related tasks.


 


Article 11 - Suspension of the AUTHORIZATION
KEY and LICENSE KEY


 


SIEMENS
is entitled to suspend the AUTHORIZATION KEY for the INTERFACE issued to the Receiver at any time, resulting
in the END USER no longer being able to use the Receiver’s PRODUCTS, if
in SIEMENS’ reasonable judgment there is a risk that the use of the Receiver’s PRODUCT by the END USER will: (i) constitute
a threat to the security or functionality of the END USER’S systems;(ii) adversely impact the END USER, the
Receiver, SIEMENS, the Receiver’s or SIEMENS’ AFFILIATES,
or any third party, including,
without limitation, any risk of personal injury; [or (iii) subject
the END USER, the Receiver, SIEMENS, the
Receiver’s or SIEMENS’ AFFILIATES, or any third party
to liability for personal injury or IP infringement]. Furthermore, SIEMENS
is entitled to suspend the LICENSE KEY if such revocation is required by law, a
court decision, or a request from a governmental body; and (iii) SIEMENS is entitled to revoke the END USER LICENSE KEY for the
relevant END USER if, in each case for security or compliance reasons
or requests from a governmental body, its access to the INTERFACE has been suspended or the agreement between SIEMENS and the END USER has been terminated by SIEMENS or the END USER.
SIEMENS will, whenever
reasonably possible, consult with Receiver in advance of the revocation
of a LICENSE KEY. SIEMENS will inform the Receiver about any revocation
of a LICENSE KEY as soon as possible. SIEMENS will reinstate any
suspended AUTHORIZATION KEY or LICENSE KEY once the circumstances giving rise to such suspension have been remedied.


 




    CONFIDENTIAL


    18 / 26


    

 


Article 12 - Notification Page


 


SIEMENS
is entitled to notify the Receiver, END USERS, and
authorities in a suitable form at any time, if: (i) in SIEMENS’
reasonable judgment there is a risk that the use of the Receiver’s PRODUCTS by the END USER will: (a) threaten the security
or functionality of the END USER’s systems; (b) adversely impact the END USER or any third party, including,
without limitation, any
risk of personal injury; or (c) subject the END USER or any third party to liability for personal injury or IP infringement; or
(ii) such notification is required by law, a court decision, or
a request from a governmental body; provided that SIEMENS will notify Receiver prior to providing any such notice to END USERS
or authorities.


 


The
Receiver acknowledges that a revocation of the AUTHORIZATION KEY or the LICENSE KEY pursuant to and in compliance with the conditions
of Article 11 - or a notification pursuant to and in compliance
with this Article by SIEMENS does not lead to any responsibility of SIEMENS.


 


Article 13 - Support


 


Where
END USERS contact SIEMENS for support queries, SIEMENS will: (i)
process queries concerning the SIEMENS MAGNETOM SCANNERS and provide all support with respect to the SIEMENS MAGNETOM SCANNERS;
and (ii) forward queries concerning the Receiver’s PRODUCT to the Receiver within a reasonable period of time and the Receiver
(and not SIEMENS) will have responsibility for providing the support. Upon
receipt, the Receiver will forward support queries from END USERS
concerning the SIEMENS MAGNETOM SCANNER to SIEMENS within a reasonable period of time. Each
PARTY may notify the other PARTY of changes to its point of contact at least two (2) weeks in advance, e-mail
being sufficient.


 




    CONFIDENTIAL


    19 / 26


    

 


Article 14 - Liability


 


		14.1	The PARTIES agree that other than as set
out in this Agreement: any information is made available “as is” and no warranties are given or liabilities of any
kind are assumed with respect to the quality of such information, including, but
not limited, to its fitness for the purpose, non-infringement
of third-party rights, its correctness or completeness. Furthermore,
none of the Parties’ obligations under this Agreement shall be deemed
to constitute a guaranteed quality or other guarantee. In addition, other
than as expressly set out in this agreement, each of the Parties
disclaims any strict liability for defects and non-conformance already existing when this contract was concluded.



 


		14.2	This clause 14 sets out the entire financial
liability of each of the PARTIES (including any liability for the acts or omissions of its AFFILIATES, employees,
agents, consultants and subcontractors) under this Agreement, including
in respect of any breach and any representation, statement or tortious act or omission (including negligence), indemnity,
warranty, or
strict liability arising under or in connection with this Agreement.



 


		14.3	Subject to clause 14.4
the liability of each PARTY under this Agreement shall be limited to direct losses and only to an amount of EUR 250,000-
for each single damage event and subject to a maximum of EUR 1,000,000-
for all such events. Claims for other indirect losses, including
but not limited to claims for business stoppage, indirect lost profit, loss
of information or data as well as consequential, special or incidental
losses shall be excluded regardless of their legal grounds.



 


		14.4	This disclaimer of liability shall not
apply in cases involving intent or gross negligence, or where liability is mandatory by law.



 


		14.5	The Receiver will, in
its sole responsibility, decide on the use of the INTERFACE,
the SDK, the
DEVELOPER SERVICES, the INFORMATION or any other material provided
through SIEMENS. SIEMENS does not assume any liability for defects
of or damages to the END USER’S systems resulting from the use of the INTERFACE, the
SDK, the DEVELOPER SERVICES, the
INFORMATION or any other material provided through SIEMENS and hereby waives and excludes any and all liability arising out of
or in connection with the use of the INTERFACE, the SDK,
the DEVELOPER SERVICES, the
INFORMATION or any other material provided through SIEMENS beyond the intended use whether based on contract, tort,
negligence, under an indemnity, warranty,
strict liability or otherwise except to the extent such defect or damage
is caused or contributed to by a negligent act or negligent omission of SIEMENS, or a breach of this Agreement.



 




    CONFIDENTIAL


    20 / 26


    

 


		14.6	Subject to of the INTERFACE, the
SDK, the DEVELOPER SERVICES, the
INFORMATION or any other material provided through SIEMENS or its AFFILIATES is the responsibility of the Receiver.



 


Article 15 - Confidentiality


 


		15.1	“CONFIDENTIAL INFORMATION”
shall mean any information and data, including without limitation,
any kind of business, commercial
or technical information and data disclosed by the Receiver to SIEMENS or SIEMENS to the Receiver in connection with the execution
or performance of this Agreement, irrespective of the medium in
which such information or data is embedded, which is:



 


		·	when disclosed in tangible form –
marked “Confidential” by the disclosing PARTY



		·	or when disclosed orally or visually –
identified as such prior to disclosure and summarized in writing by the disclosing PARTY and said summary is given to the receiving
PARTY within thirty (30) days after such disclosure marked “Confidential”. In case of disagreement regarding orally
or visually disclosed information, the receiving PARTY must present
its objections to the summary in writing within thirty (30) days
of receipt



 


CONFIDENTIAL
INFORMATION shall also include any copies or abstracts made thereof as well as any apparatus, data,
modules, samples, prototypes or parts thereof.


 


For
the avoidance of doubt, the pricing information described in Article
6.1 and Article 6.3, the library of examples, the SDK, the
INTERFACE description shall deemed to be SIEMENS CONFIDENTIAL INFORMATION irrespective of the fact if they are marked or not.
All information about the PRODUCTS or Receiver’s business practices
which is not made generally available to the public and the pricing information described in Article 6.1
and Article 6.3 shall be deemed Receiver CONFIDENTIAL INFORMATION.


 


		15.2	The receiving PARTY shall maintain CONFIDENTIAL
INFORMATION received from the disclosing PARTY in confidence and will use such CONFIDENTIAL INFORMATION solely for the purposes
of this Agreement, and shall not distribute or disclose it,
provided, however,
that the receiving PARTY may disclose such information to its officers,
AFFILIATES, and those of its employees and subcontractors who need
to know it for the purposes of this Agreement. Each PARTY shall
impose on its officers, AFFILIATES, and its employees and subcontractors
confidentiality obligations no less stringent than its own confidentiality obligations under this Agreement, and
the receiving PARTY will be responsible for any violation of the confidentiality obligations under this Agreement by any of its
officers, AFFILIATES, employees
or subcontractors.



 


		15.3	The obligations of Article 15.2 shall
remain in force for a period of five (5) years after the termination of this Agreement. CONFIDENTIAL
INFORMATION (as defined in the Original Agreement) disclosed by either PARTY under the Original Agreement shall be deemed CONFIDENTIAL
INFORMATION disclosed under this Agreement and shall be subject to the provisions of this Article 15.



 




    CONFIDENTIAL


    21 / 26


    

 


		15.4	The obligations of Article 15.2
shall not apply to information which is or becomes generally known to the public or which has been obtained independently as evidenced
by a PARTY’S business records or acquired legitimately from OTHERS who are to the knowledge of the receiving PARTY free to
lawfully disclose the information.



 


		15.5	The provisions of Article 15.2
hereof shall apply to copies of electronically exchanged CONFIDENTIAL INFORMATION made as a matter of routine information technology
backup and to CONFIDENTIAL INFORMATION or copies thereof which must be stored by the receiving PARTY or its advisers according
to provisions of mandatory law or as required by regulatory bodies such as the FDA, and
such CONFIDENTIAL INFORMATION or copies thereof shall be subject to an indefinite confidentiality obligation according to the terms
and conditions set forth herein.



 


		15.6	Save as set out in Article 15.5
above, within ninety (90) calendar days after termination of this
Agreement, the receiving PARTY shall destroy or, as may be requested
by the disclosing PARTY, return all CONFIDENTIAL INFORMATION received
and stored electronically and/or on record-bearing media as well
as any copies thereof. The receiving PARTY shall confirm in writing such destruction to the disclosing PARTY. Excluded
from the obligations set out in this Article 15.6 is information that the Receiver is required to retain in his technical files
relating to the PRODUCTS or information that: (a) is required to enforce or comply with the terms of this Agreement or Receiver’s
agreements with End Users; or (b) is stored in accordance with a Party’s back-up and disaster recovery systems.



 


Article
16 - Agreement Term, Notification and CHANGE-OF-CONTROL


 


		16.1	This Agreement shall come into force when
signed by both PARTIES and shall have a term for sixty (60) months.
Unless earlier terminated, the Agreement shall be extended for
successive terms of one (1) year each unless written notice to terminate is given by either PARTY at least three (3) months before
the end of the respective contract term.



 


		16.2	Each PARTY shall be entitled to terminate
this Agreement prematurely by means of written notice, if the other
PARTY breaches a material obligation and fails to rectify the aforesaid breach within ninety (90)
calendar days of the non-breaching PARTY’s notice.



 


		16.3	If there is a CHANGE-OF-CONTROL to a COMPETITOR of SIEMENS:



		•	the Receiver shall inform SIEMENS in writing within fifteen (15) calendar days, but under no circumstance
later than any public announcement by the Receiver,



 




    CONFIDENTIAL


    22 / 26


    

 


		•	The PARTIES shall discuss in good faith
within thirty (30) calendar days after SIEMENS has been informed
in writing by the Receiver,



		•	In particular, it
shall be discussed how such CHANGE OF CONTROL would impact the relationship contemplated by this Agreement, including
whether the Receiver or such COMPETITOR will terminate this Agreement after the closing of such CHANGE OF CONTROL transaction,
and



		•	SIEMENS shall be entitled to terminate
with immediate effect this Agreement within sixty (60) calendar
days after SIEMENS has been informed in writing by the Receiver of such CHANGE OF CONTROL involving a COMPETITOR of SIEMENS,
provided that SIEMENS, acting reasonably, shall only terminate this Agreement
if such CHANGE OF CONTROL transaction involving a COMPETITOR of SIEMENS will have a detrimental impact on the PARTIES collaboration
hereunder relating to the PRODUCTS and SIEMENS MAGNETOM SCANNERS.



 


		16.4	The provisions in Article 7 - ,
Article 10 - Article
11 - Article 12 - Article
14 - this Article 16.4
and Article 19 - shall survive the expiration or termination of
this Agreement. With regards to the PRODUCTS which have already been connected to SIEMENS MAGNETOM SCANNERS before expiration or
termination of this agreement the licenses granted for the AUTHORIZATION KEY shall be unaffected as well as the corresponding obligation
to pay the license fee as set forth in Article 2, Article 6 and
Article 8 for all granted AUTHORIZATION KEYs., unless and until
such time as Receiver specifies which individual or all such AUTHORIZATION KEYS are no longer in use. Then the Receiver only has
the obligation to pay the license fee for all the AUTHORIZATION KEYs still in use.



 


Article 17 - Force Majeure


 


		17.1	A PARTY shall not be in breach of this
Agreement, nor liable for any failure or delay in the performance
of any of its obligations under this Agreement as a result of force majeure event provided that:



 


		17.1.1	it promptly notifies the other PARTY in writing of the nature and extent of the force majeure event
causing its failure or delay in performance; and



 


		17.1.2	it has used reasonable endeavors to mitigate
the effect of the force majeure event, to carry out its obligations
under this Agreement in any way that is reasonably practicable and to resume the performance of its obligations as soon as reasonably
possible.



 


		17.2	‘Force majeure event’ in the sense of this Agreement shall be one of the following
events which is outside the control of a PARTY and its suppliers and contractors and prevents that PARTY from meeting its contractual
obligations:



 


		17.2.1	acts of God, fires, floods,
earthquakes or other natural disasters;



 




    CONFIDENTIAL


    23 / 26


    

 


		17.2.2	war, embargo, terrorist
attack, riots;



 


		17.2.3	explosion or building collapse;



 


		17.2.4	failure of plant machinery, interruption
or failure of utility service, including but not limited to electric power, gas
or water.



 


		17.3	If either PARTY is prevented from meeting
its obligations under this Agreement for a continuous period of more than six (6) months as a result of a ‘force majeure
event’, the other PARTY shall be entitled, at its sole discretion,
to terminate the Agreement with one (1) month’s written notice.



 


Article 18 - Miscellaneous


 


		18.1	Neither PARTY shall be entitled, without
the prior written consent of the other, to transfer or assign this
Agreement or any rights and obligations arising from it to OTHERS, except
a transfer or assignment to an AFFILIATE or a purchaser of substantially all of the assets of a PARTY, provided
that the transferring or assigning PARTY shall remain responsible for the fulfilment of the obligations it originally incurred
under the Agreement. Consent hereto shall not be unreasonably withheld.



 


		18.2	SIEMENS’ obligation to fulfill this Agreement is subject to the proviso that the fulfillment
is not prevented by any impediments arising out of national and international foreign trade and customs requirements or any embargos
or other sanctions.



 


		18.3	The PARTIES shall comply with all applicable
export control, customs and foreign trade regulations (“Foreign
Trade Regulations”) and shall obtain all necessary export licenses, if any.



 


		18.4	Any amendments as well as supplements
to this Agreement must be in writing and signed by the PARTY to be bound in order to be effective. A
waiver of form shall be effective only if agreed upon in writing and signed by the PARTY to be bound.



 


		18.5	If this Agreement requires a notice or
a document to be „in writing” or „in written form”, such notice or document shall be duly signed by the
sender and the signed notice or document shall be delivered, sent
or transmitted to the other PARTY in its original form or as a telefax copy or a PDF. For the avoidance of doubt, electronic
communication shall not qualify as a written notice or document unless confirmed as received by the receiving PARTY.



 


		18.6	Any general terms and conditions of the
PARTIES in addition to this Agreement shall be excluded. This shall
particularly apply if there is any reference to such terms in correspondence or other documentation of the PARTIES (e.g.,
printed, stamped
and electronically reproduced).



 




    CONFIDENTIAL


    24 / 26


    

 


		18.7	If any provisions of this Agreement should
be held to be illegal, invalid or unenforceable, the
validity, legality and enforceability of the remaining provisions
shall not in any way be affected or impaired thereby. The PARTIES
shall substitute the illegal, invalid, or unenforceable provision
by a legal, valid or enforceable one, approximating
as closely as possible the original commercial intent of the PARTIES.



 


		18.8	If provisions of this Agreement conflict
with the Annexes or other agreements, the provisions of this Agreement
shall have precedence.



 


		18.9	The Original Agreement and the PARTIES’
obligations thereunder are hereby terminated and replaced by this Agreement. [Article
7.2 of the Original Agreement shall continue to apply after the
Effective Date of this Agreement; provided that Art. 8 of the Original
Agreement shall not survive termination of the Original Agreement according to this section 18.9.



 


Article 19 - Arbitration and Substantive
Law


 


		19.1	If a dispute arises in connection with
this Agreement, the responsible representatives of the PARTIES
shall attempt, in fair dealing and good faith, to settle such dispute.
Upon request of a PARTY a senior management representative of each PARTY shall participate in the negotiations. Each PARTY shall
be entitled to terminate these negotiations by written notification to the other PARTY at any time.



 


		19.2	The PARTIES shall attempt to agree on
a procedure for Alternative Dispute Resolution (ADR) and the applicable procedural rules (including time limits) within fourteen
days after a termination notice under Article 19.1 has been received by the other side. If the PARTIES fail to agree on such procedure
within this time limit each PARTY shall be entitled to refer the dispute to arbitration pursuant to Article 19.3.



 


		19.3	All disputes arising in connection with
this Agreement which are not resolved pursuant to Article 19.1
or an ADR procedure, including any question regarding the termination or any subsequent amendment of the Agreement, shall
be finally settled in accordance with the Rules of Arbitration (“Rules”) of the International Chamber of Commerce (“ICC”).
The seat of arbitration shall be Zurich Switzerland. The
language to be used in the ADR and the arbitration proceeding shall be English. Any
production of documents shall be limited to the documents on which each PARTY specifically relies in its submission(s). Consolidation
of arbitrations pending under the Rules into a single arbitration shall only be possible if the PARTIES have agreed to consolidation.
The unsuccessful PARTY shall bear the costs of the arbitral proceedings.
However, the arbitral tribunal may take into account the extent to which
each PARTY has conducted the arbitration in an expeditious and cost-effective
manner.



 




    CONFIDENTIAL


    25 / 26


    

 


		19.4	This Agreement shall be subject to the substantive law in force in Germany without reference to
any of its conflict of law rules.



 




    CONFIDENTIAL


    26 / 26


    

 


..............


 


	Place, Date:	 	 
	 	 	 
	Mississauga, Ontario, February 11, 2019	 	 
	 	 	 
	/s/ Aaron Davidson	 	/s/ Arun Menawat
	 	 	 
	Name (Print):	 	Name (Print):
	Aaron Davidson	 	Arun Menawat
	 	 	 
	Title:	 	Title:
	Chief Financial Officer	 	Chief Executive Officer
	 	 	 
	SIEMENS Healthcare GmbH	 	 
	 	 	 
	Place, Date:	 	 
	 	 	 
	Erlangen, Germany, January 23, 2019	 	 
	 	 	 
	/s/ Dr. Robert Krieg	 	/s/ Peter
    Horn
	 	 	 
	Name (Print):	 	Name (Print):
	Dr. Robert Krieg	 	Peter Horn
	 	 	 
	Title:	 	Title:
	VP MR Advanced Solutions & Therapy	 	Senior Vice President Finance
	 	 	Magnetic Resonance


 




    CONFIDENTIAL


     


    

 


Annex 1


 


Specification of INFORMATION


 


Preamble


 


SIEMENS provides the INFORMATION to the Receiver for the sole
purpose of interfacing the PRODUCTS to certain SIEMENS MAGNETOM SCANNERS and to deliver such adapted PRODUCTS to END USERS for
interworking with SIEMENS MAGNETOM SCANNERS. The INFORMATION in scope are described in this Annex.


 


Interface description


 


Access-I
developer guide with comprehensive documentation of the interface, intended for a developer to integrate against this interface.
Includes descriptions of the setup, configuration, methods of
the interface with examples.


 


Software Development Kit (SDK)


 


A
test environment is provided to ease the development, integration and testing of remote clients with Access-i. It comprises
an Access-I Simulator and a Test Client, which are designed
for a Windows PC environment.


 


The Access-i Simulator enables the remote client implementation
and testing without the need for physical access to an MR scanner. It mimics the Access-I related functionality of the MR host


 


The Access-i
Test Client provides an example implementation of a
remote client, and also serves as a reference to verify the functionality of the Access-i interface.


 


Source Code toolbox


As part of the SDK, some source code toolboxes are included
to provide an example implementation of a remote client. These can be used in the development of the remote client to enable faster
development


 




     


     


    

 


Annex 2


 


Specification of PRODUCTS


 


Preamble


 


SIEMENS
provides the INFORMATION to the Receiver for the sole purpose of interfacing the PRODUCTS to certain SIEMENS MAGNETOM SCANNERS
and to deliver such adapted PRODUCTS to END USERS for interworking with SIEMENS MAGNETOM SCANNERS. The PRODUCTS in scope are described
in this Annex.


 


Product Name


 


TULSA-PRO


 


Sonalleve


 


Product Description


 


TULSA-PRO: MRI guided directional ultrasound ablation of soft
tissue


 


Sonalleve:
MRI guided high-intensity focused ultrasound of soft tissue, bone
and nerves


 


Intended Use


 


TULSA-PRO: MRI guided directional ultrasound ablation of soft
tissue


 


Sonalleve: MRI guided high-intensity focused ultrasound of soft
tissue, bone and nerves


 




     


     


    

 


Regulatory Status and Regulatory Roadmap


 


TULSA-PRO: Approved in EU and soon to be in registration in
the US


 


Sonalleve:
Approved in the EU, and several Asian countries including
China and soon to be in registration in the US


 


MR-Compatibility Status


 


TULSA
-PRO: Intention is to be compatible with all Siemens scanners upon which
Access I can be operational


 


Sonalleve: Intention is to be compatible with all Siemens scanners
upon which Access I can be operational


 




     


     


    

 


Annex 3


 


Agreement for risks exported in using
Access-i


 


Preamble


 


Siemens Healthcare GmbH has created a risk analysis according
to their risk management process fulfilling the requirements given by IS014971:2012. Listed below are the residual risks related
to the use of “Access-i” interface that cannot be further mitigated by Siemens Healthcare GmbH and which the Receiver
accepts in using this interface functionality. It is the responsibility of the Receiver to ensure that the appropriate measures
are in place to mitigate these risks in using this’ interface functionality.


 


Risks exported to the Receiver using the Access-i interface:


 


	No	 	Function 	 	Error	 	Cause	 	Hazard	 	Measure(s)
	 	 	 	 	 	 	 	 	 	 	 
	1	 	 	 	NUMARIS/4 product SW crash or instability, loss
    in performance.	 	SW hang-up / Side effects / secondary effects on NUMARIS/4 product SW	 	Delayed diagnosis	 	It must be ensured, that the status of the MR system always corresponds to the required status (e.g. sequence is running) during safety relevant interventions
	2	 	Remote PC- control session active	 	
        No fast way to stop the MR measurement and/or patient table
        movement in an emergency situation.

         

        Visual and audio contact to the patient (window / video / Intercom
        system (cf. above)) not possible.
	 	The patient intercom system / video supervision remains at the MR AWP and is not available at the remote PC.	 	Various!	 	Patients must be monitored, always and it needs to be ensured that MR measurement can be stopped in emergency situations.
	3	 	 	 	Connection between MR AWP and remote PC gets lost.	 	Technical defect; Forced control take over at the MR AWP (e.g. by User); Remote session is aborted (intended or unintended)	 	Burns up to 2nd degree; misdiagnosis; Jamming or injection / infusion needles pulled out – minor or moderate injury	 	A termination or a break of the connection between the MR AWP and the remote PC must be recognized. In this case the procedure (e.g. intervention) must be handled appropriately (e.g. stopped).
	4	 	 	 	Parameters are accidently changed on the MR AWP	 	Access to MR System by MR AWP between two remote control sessions possible.	 	Delayed diagnosis	 	It must be ensured that the protocol parameters are not changed unintentionally before each procedure (e.g. intervention). Only Personnel that are trained must use the MR-Device and the remote PC. It is recommended to have at least two persons for the workflow.
	5	 	Remote PC – Untrained Personnel	 	MR device not used correctly	 	Untrained personnel are using the MR Device (via remote control)	 	Various!	 	Only Personnel which are trained must use the MR-Device and the remote PC. It is recommended to have two persons for the workflow.
	6	 	Remote PC – Popup Issue service	 	Popup confirmed (automatically) by remote PC SW	 	Malfunction of remote PC software or intended automated popup confirmation.	 	Misdiagnosis	 	The remote PC SW must consider all popup related information provided by MR AWP via the issue service for safe and proper use of the MR Device; e.g. automatic table movement. Popups can be handled automatically by SW, if the consequences are known and measures are implemented to prevent resulting hazards.
	7	 	Remote PC – Debugging service	 	Start of savelog generation shortly before a sequence is started	 	Savelog generation can take up to 5 minutes and can lead to a longer reconstruction time	 	Delayed diagnosis	 	If update rate of date is not sufficient for the required application the procedure (e.g. intervention) must be handled appropriately (e.g. stopped).
	8	 	Remote PC – Image Service	 	Image service and/or projection service not available	 	Automatic receive of images via websocket functionality	 	Delayed diagnosis	 	If update rate of date is not sufficient for the required application the procedure (e.g. intervention) must be handled appropriately (e.g. stopped).