(A) Novo is a global healthcare company specializing in the
development of treatments for diabetes and other serious chronic
conditions, and is the manufacturer of the NovoPen® 6 and NovoPen
Echo® Plus (together referred to as the “NovoPen”), a medical device
used to assist patients self-administer insulin and which is capable
of connecting to certain digital mobile applications, software systems
and devices to allow patients to view data stored on the NovoPen.
(B) Novo wishes to make the NovoPen as accessible as possible to
patients and recognizes that third party mobile applications, software
systems or other digital devices may help facilitate the use of the NovoPen.
(C) Novo is willing to share the Specifications (as defined below)
with Developer so that Developer may connect Solutions (as defined
below) to the NovoPen, subject to Developer’s compliance with the
obligations set out in this Agreement.
In this Agreement, the following terms shall have the following definitions:
1.1 “Affiliate” means any company or other entity which directly or
indirectly controls, is controlled by or is under common control with
a party, where ‘control’ means the ownership of more than 50% of the
issued share capital or other equity interest or the legal power to
direct or cause the direction of the general management and policies
of such party, company or other entity.
1.2 “Applicable Law” means all laws, rules, regulations, codes of
practice, or other requirements of regulatory authorities, as amended
from time to time, including the Medical Devices Legislation and the
Data Protection Legislation.
1.3 “Developer Content” means all text, information, data, software,
executable code, images, audio or video material, in whatever medium
or form, relevant for the purpose of using, developing or maintaining
any Solution, and all information related to End-Users processed or
stored by any Solution.
1.4 “Data Protection Legislation” means all applicable data
protection legislation in force from time to time, including the
General Data Protection Regulation (EU) 2016/679 .
1.5 “End-User” means any user of the Solution.
1.6 “Intellectual Property” means all patents, utility models,
rights to inventions, copyright and neighbouring and related rights,
trademarks and service marks, business names and domain names, rights
in get-up and trade dress, goodwill and the right to sue for passing
off or unfair competition, rights in designs, database rights, rights
to use, and protect the confidentiality of, confidential information
(including know-how and trade secrets) and all and other Intellectual
Property rights, in each case whether registered or unregistered and
including all applications and rights to apply for and be granted,
renewals or extensions of, and rights to claim priority from, such
rights and all similar or equivalent rights or forms of protection
that subsist or will subsist now or in the future in any part of the world.
1.7 “Medical Devices Legislation” means medical device legislation
applicable to the Solution. For the avoidance of doubt, if the
Solution is made available on the EU market, Medical Device
Legislation shall include Directive 93/42/EEC and Regulation (EU) 2017/745.
1.8 “NovoPen Data” means all data, including any Personal Data,
recorded by the NovoPen (e.g. dose, timestamp) or derived from
Developer’s connection with the NovoPen.
1.9 “Personal Data” means any information relating to an identified
or identifiable natural person.
1.10 “Specifications” means Novo’s specifications for the NovoPen
and any other documentation or other materials, relating to the
NovoPen made available by Novo to Developer for the purpose of
connecting and integrating the Solutions to the NovoPen.
1.11 “Solution” means any mobile application, software system or
other device developed by Developer which Developer intends to connect
or integrate with the NovoPen.
1.12 “User Data” means any and all data, including any Personal Data
and NovoPen Data, collected and processed by Developer through any
Solution, or otherwise obtained in connection with Developer’s
relationship with any End-User.
2. LICENSE TO SPECIFICATIONS
2.1 Novo will provide a copy of the Specifications and samples of
the NovoPen to Developer following the Effective Date.
Subject to the terms of this Agreement (including clause 10.2),
Novo hereby grants to Developer a worldwide, fully paid-up,
non-exclusive, non-assignable, non-sub-licensable, license to use the
Specifications, with effect from Developer’s receipt of such
Specifications from Novo, solely as necessary or useful to connect and
integrate the Solutions with the NovoPen.
2.2 Novo may change the NovoPen or Specifications from time-to-time
at Novo’s discretion and Developer is solely responsible for procuring
any updates and other amendments to the Solutions, and for maintaining
the functionality of the Solutions, as may be necessary to reflect any
such changes to the NovoPen or Specifications.
2.3 Novo will, to the extent possible, notify Developer in advance
of any changes to the NovoPen or the Specifications via email or the
Novo Nordisk Developer Portal.
2.4 Developer will not under any circumstances use samples of the
NovoPen for administering to humans or animals.
3. DEVELOPER OBLIGATIONS
3.1 Developer will comply with all Applicable Law in its performance
of this Agreement.
3.2 Subject to and without limiting clause 3.1, Developer
acknowledges and agrees that:
(a) for the purposes of the Medical Devices Legislation, Developer
is the legal manufacturer of each Solution (to the extent such
Solution is a medical device) and Novo is the legal manufacturer of
(b) Developer will develop and market all Solutions in accordance
with Applicable Law, including but not limited to only making the
Solutions available in territories where the NovoPen is approved for
use by the relevant regulatory authority, and is solely responsible
for conducting pre-market testing and ongoing monitoring in respect of
the Solutions. For the avoidance of doubt and irrespective of any
provisions in this Agreement, Developer is expressly restricted from
making the Solution available to individuals in the United States of
America as well as making any statements directly or indirectly
referring to NovoPen in any capacity or on any platform that
addressing individuals residing in the United States of America;
(c) Developer is solely responsible for ensuring the safety and
performance of the Solutions for their intended use and for any
Developer Content, including content displayed to End-Users;
(d) Developer is solely responsible for verifying the suitability of
the Specifications for the intended use of the Solutions;
(e) Novo is not responsible in any manner for the content or use of
any Solution or Developer Content or for the accuracy of any data
obtained by End-Users through any Solution;
(f) Developer may not use any Novo Intellectual Property except to
the minimum extent necessary to indicate that a Solution can connect
with the NovoPen, and provided only that such use of Novo Intellectual
Property is limited to use on the Developer’s website, on mobile
application stores and/or as a push notification via the Solution to
End-Users as specified below; where necessary to explain the
functionality of the Solution. Notwithstanding the foregoing,
Developer may not imply (directly or indirectly) that any Solution is
compatible with the NovoPen or that it has been assessed or endorsed
by Novo in any way. For the avoidance of doubt, Novo will not object
to Developer using the following statement “The [Solution] connects
with NovoPen” and Developer will not object to Novo using the
following statement “NovoPen connects with [the Solution]”. In respect
of the push notification Novo will not object to Developer informing
End-Users of the connectivity with the NovoPen using the following
statement: “[Solution] now connects with the NovoPen in selected
countries, please visit [Developer website] for more information”.
Developer shall not make any public statement, written or oral,
referring to Novo’s devices or drugs without Novo’s prior review and
written approval. Further, Developer will include the following
prominent disclaimer on all Solutions: “[Solution] has NOT been
developed with, assessed by, or in any way endorsed by Novo Nordisk
A/S and compatibility has NOT been assessed by Novo Nordisk A/S for
use with the NovoPen® 6 or the NovoPen Echo ® Plus. [Developer] is the
manufacturer of the [Solution] and is solely responsible for ensuring
the safety and performance of the [Solution] for its intended use.
Novo Nordisk A/S is not responsible in any manner for the content or
use of the [Solution] nor for the accuracy of any data obtained
through use of the [Solution]”; and
(g) Developer will without undue delay notify Novo of all field
safety corrective actions (including recall procedures), adverse
incidents, events, reports or complaints (“Safety Information”)
relating to any Solution or otherwise relevant to the NovoPen and the
parties will consult on such issues. Developer will be responsible for
taking any relevant actions with respect to any such Safety
Information as may be required by Applicable Law in relation to any
Solution, including, where necessary, for communicating such Safety
Information to the applicable governmental and regulatory
authorities. For the avoidance of doubt, Novo will be responsible for
taking any relevant actions with respect to any Safety Information
relating to the NovoPen. Developer will promptly comply with all
reasonable requests of Novo regarding the handling and reporting of
any Safety Information.
(h) Solely to comply with post-market surveillance requirements
under Applicable Law, Novo will at least annually provide Developer
with a survey regarding the performance of the NovoPen. Developer
shall respond to such surveys within 14 (fourteen) business days of receipt.
(i) Developer will once annually during the Term provide Novo with
an overview of total number of End-Users and breakdown per country.
4.1 Developer will process all User Data in accordance with
Applicable Law and Developer will have its own end user license
to each Solution.
4.2 Developer shall not access, analyse or otherwise process NovoPen
Data beyond what is strictly necessary for the Solution to function
for the End-User.
4.3 Developer shall not share or make any NovoPen Data available to
any third party without Novo’s prior written approval. Irrespective
hereof, Developer may make NovoPen Data available to data vendors who
work on behalf of Developer, solely to the extent necessary for said
data vendors to provide data hosting, transfer and storage services to
Developer, and Developer shall prohibit said data vendors from i)
using the NovoPen Data for its own benefit, or for the direct or
indirect benefit of any other third party, and ii) enriching or
combining the NovoPen Data with other data or taking any other
actions that may result in it being reasonably likely for the data
vendor to identify an End-User.
4.4 Irrespective of clause 4.3, Developer may upon request from
End-User, export NovoPen Data for that End-User to the End-User(s)
healthcare professional, caregivers and/or clinical investigators for
non-commercial use and to the extent that export is for the purpose of
the End-User receiving medical care.
4.5 Upon Novo’s request, Developer shall negotiate with Novo in good
faith an agreement to enable Novo to access User Data for the NovoPen
users. Any such agreement will be subject to Developer obtaining and
maintaining any and all permits, consents, licenses and any other
authorizations required to share any such User Data with Novo. Unless
and until Novo and Developer agree and enter into such agreement,
Developer will not share any User Data with Novo.
5. NO FEES
5.1 The parties acknowledge and agree that no license fees or other
payments will be due under this Agreement in exchange for the rights
granted under this Agreement. The parties acknowledge and agree that
this fee arrangement is made in consideration of the mutual
obligations set out in this Agreement.
6. INTELLECTUAL PROPERTY RIGHTS
6.1 Novo will own and retain all Intellectual Property rights in or
relating to or arising out of or in connection with the NovoPen and
the Specifications. Except as expressly set out in this Agreement,
Developer will not acquire any right, title or interest in any
Intellectual Property of Novo.
6.2 Developer will own and retain all Intellectual Property rights
in or relating to or arising out of or in connection with any
Solution. Except as expressly set out in this Agreement, Novo will
not acquire any right, title or interest in any Intellectual Property
6.3 Developer is not permitted to use any names, trade names,
trademarks, logos, marketing materials or any other Intellectual
Property of Novo within any Solution nor related products and
services, or for the promotion thereof, except where expressly set out
in this Agreement or agreed by Novo in writing in advance of any such
use. To the extent any such use is permitted, Developer’s use of any
such Intellectual Property will: (i) not bring Novo into disrepute;
and (ii) terminate immediately on termination of this Agreement. If
Novo reasonably objects to any such use then Developer will
immediately stop using the relevant materials in the manner specified
6.4 Developer will not perform analysis or create any external
materials (for example, but not limited to publications, promotional
materials, clinical study results) comparing data from or derived from
Developer’s connection with the NovoPen to other insulin drugs, other
insulin pens or other insulin devices or systems.
7.1 Developer undertakes that it will not disclose to any person any
information disclosed to it by Novo or its Affiliates, or otherwise
acquired by Developer, prior to or in the course of or otherwise in
connection with this Agreement concerning the business, affairs,
clients, customers, trade secrets, technical know-how, clients or
suppliers of Novo and/or its Affiliates, including the Specifications
and samples of the NovoPen (“Confidential Information”), except as
expressly permitted by clause 7.2. Confidential Information does not
include any information that is in or comes into the public domain
(other than through breach of this Agreement or other wrongful act by
Developer) or that was lawfully known to Developer prior to disclosure
by Novo or its Affiliates or acquisition by Developer in the course of
7.2 Developer may disclose Confidential Information:
(a) to its employees or subcontractors strictly on a need to know
basis for the purposes of carrying out Developer’s obligations under
this Agreement. Developer will ensure that its employees and/or
subcontractors to whom it discloses any Confidential Information are
aware of the confidential nature of the Confidential Information prior
to disclosure and comply with this clause 7 and Developer shall be
responsible to Novo for any act or omission of any such employee or
(b) as may be required by law, a court of competent jurisdiction or
any governmental or regulatory authority, provided that, unless
prohibited by law or regulation, it notifies Novo in advance prior to
making any such disclosure.
7.2.2 Developer may not use any Confidential Information for any
purpose other than to exercise the limited right granted to it under
7.3 All Confidential Information, including all documents and
materials, and copies or extracts thereof, containing, reflecting,
incorporating or based on the Confidential Information, will be and
remain the property of Novo.
8. WARRANTIES AND DISCLAIMERS
8.1 Developer warrants, represents and undertakes to Novo that it:
(a) has the necessary power and authority to enter into this Agreement;
(b) will comply with all Applicable Laws in performance of this
(c) will perform its obligations under this Agreement with the
highest level of skill and care.
9. LIMITATION OF LIABILITY
9.1 Nothing in these terms will limit or exclude Novo’s liability for:
(a) death or personal injury caused by its negligence, or the
negligence of its employees, agents or subcontractors;
(b) fraud or fraudulent misrepresentation; or
(c) any other liability which cannot be limited or excluded by
9.2 Subject to clause 9.1, Novo will not under any circumstances
whatsoever be liable to Developer, whether in contract, tort
(including negligence), breach of statutory duty, misrepresentation or
otherwise, for any direct or indirect loss of profit, loss of
business, depletion of goodwill and/or similar losses or loss or
corruption of data or information, or pure economic loss, or for any
other special, indirect or consequential loss, costs, damages, charges
or expenses however arising under or in connection with this Agreement.
9.3 Except as expressly provided in this Agreement, there are no
conditions, warranties or other terms binding on Novo with respect to
actions contemplated by this Agreement. Developer acknowledges and
agrees that to the maximum extent permitted by Applicable Law that the
Specifications and samples of NovoPen are provided ‘as is’ and without
any representations or warranties of any kind, express, implied or
statutory, and Novo expressly disclaims any and all such warranties,
including any warranty of merchantability, non-infringement, accuracy
or fitness for a particular purpose. Novo will not under any
circumstances whatsoever be liable for Developer’s use of the NovoPen
or any Solution nor for any Developer Content.
9.4 Developer will indemnify Novo and its Affiliates and its and
their officers and employees from any claim, loss, liability or
expense (including legal costs) in connection with any breach by
Developer of this Agreement or Developer’s use of any Solution,
including in conjunction with the NovoPen.
10. TERM AND TERMINATION
10.1 This Agreement will come into force on the Effective Date and
will remain in force until terminated by either party in accordance
with clause 10.2 (the “Term”).
10.2 Without affecting any other right or remedy available to it:
(a) Novo may at any time cease use of Specifications and/or suspend
Developer’s access to the Specifications; and
(b) either party may terminate this Agreement with immediate effect
by giving written notice to the other party.
10.3 On termination of this Agreement for any reason:
(a) Developer will promptly destroy or delete the Specifications and
any other materials (including any Confidential Information) in
Developer’s possession or control, and shall certify to Novo in
writing its compliance with this clause 10.3(a)
(b) the accrued rights, remedies, obligations and liabilities of the
parties as at expiry or termination will be unaffected, including the
right to claim damages in respect of any breach of this Agreement
which existed at or before the date of termination or expiry; and
(c) clauses 3, 4, 6, 7, 9 and 10.3, will survive termination
and continue in full force and effect.
11.1 Notices under this Agreement must be sent via email to the
other party’s Email Address indicated in the Coversheet to this
Agreement, which will be deemed received at the time of transmission,
or if this time fall outside of Business Hours in the place of
receipt, when Business Hours resume. “Business Hours” means 9.00 am to
5.00 pm Monday to Friday on a day that is not a public holiday in the
place of receipt.
12.1 Developer may not assign or transfer any of its rights or
obligations under this Agreement in whole or in part without the prior
written consent of Novo.
13. ENTIRE AGREEMENT
13.1 This Agreement supersedes all previous conditions
understandings, commitments, agreements or representations (other than
fraudulent misrepresentations) whatsoever whether oral or written
relating to the subject matter hereof and constitutes the entire
agreement between the parties relating to the subject matter hereof.
Each party acknowledges that in entering into this Agreement it does
not rely on, and will have no remedies in respect of, any statement,
representation, assurance or warranty (whether made innocently or
negligently) that is not set out in this Agreement. Each party agrees
that it will have no claim for innocent or negligent misrepresentation
or negligent misstatement based on any statement in this Agreement.
14.1 No waiver of any term or condition of this Agreement will be
effective unless made in writing and signed by the party against which
enforcement of the waiver is sought. The waiver of any breach of any
term or condition of this Agreement will not be construed as a waiver
of any subsequent breach of a term or condition of the same or a
15.1 The invalidity, illegality or unenforceability of any of the
provisions of this Agreement will not affect the validity, legality
and enforceability of the remaining provisions of this Agreement.
16. NO PARTNERSHIP
16.1 Nothing in this Agreement will constitute or be construed as
constituting or establishing any partnership or joint venture between
the parties for any purpose whatsoever.
17. GOVERNING LAW AND JURISDICTION
17.1 This Agreement, and any dispute or claim arising out of or in
connection with it or its subject matter or formation (including
non-contractual disputes or claims), will be governed by, and
construed in accordance with the laws of Denmark.
17.2 Each party irrevocably agrees that the courts of Denmark will
have exclusive jurisdiction to settle any dispute or claim arising out
of or in connection with this Agreement or its subject matter or
formation (including non-contractual disputes or claims).