Exhibit 10.1

 

Certain identified information has been excluded from the exhibit because it is
both (i) not material and (ii) would likely cause competitive harm to the
Company, if publicly disclosed. Double asterisks denote omissions.

 

EXCLUSIVE DEVELOPMENT AND DISTRIBUTION AGREEMENT

 

This Exclusive Development and Distribution Agreement (this “Agreement”) is
entered into as of July 20, 2020 (the “Effective Date”), by and between Zimmer,
Inc., a Delaware corporation (“Zimmer”), and NeuroOne Medical Technologies
Corporation, a Delaware corporation (the “Company”). Zimmer and the Company are
referred to individually as a “Party” and together as the “Parties”. Capitalized
terms used herein, to the extent not otherwise defined, have the meanings
specified in Exhibit A.

 

BACKGROUND

 

A. Zimmer and its Affiliates develop, manufacture and sell medical products.

 

B. The Company has developed technology, including Strip/Grid Products, relating
to the use of electrodes for neurosurgical applications, including the diagnosis
of epilepsy.

 

C. The Parties intend to collaborate in the development of SEEG Products and
Electrode Cable Assembly Products for neurosurgical diagnostic applications,
including the diagnosis of epilepsy.

 

D. The Parties desire for Zimmer and its Affiliates to become the exclusive
distributor of certain products of the Company, including the Strip/Grid
Products and the SEEG Products that are developed as a result of the Parties’
efforts under this Agreement, in accordance with the terms and conditions of
this Agreement.

 

AGREEMENT

 

In consideration of the mutual covenants set forth in this Agreement, and
intending to be legally bound, the Parties hereby agree as follows:

 

ARTICLE I
DEVELOPMENT

 

1.1. Project Scope. The Parties will collaborate in carrying out a project (the
“Project”) to Develop the following Products for use in neurosurgical
applications:

 

(a) Strip/Grid Products;

 

(b) SEEG Products; and

 

(c) Electrode Cable Assembly Products.

 

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1.2. Development Plan. The initial development plan for the Project is set forth
in the documents attached as Exhibit B and the documents referenced therein
(collectively, as amended as provided herein, the “Development Plan”). At any
time within ninety (90) days after the Effective Date, Zimmer shall have the
right, but not the obligation, to cause the initial Development Plan to be
amended to include an Approved Design Modification by delivering written notice
to the Company (a “Design Modification Notice”). Upon receipt of a Design
Modification Notice, the Parties shall mutually determine, in good faith, the
amendments to be made to the Development Plan. Following agreement on the
required amendments, the Parties shall continue to implement the Development
Plan, as so amended. The initial Development Plan may be further amended from
time to time by the JDC as contemplated by Section 1.8.

 

1.3. Development Responsibility; Approval Rights; Project Managers. Except as
otherwise expressly stated in this Agreement or the Development Plan, the
Company shall be responsible for performing all development activities
contemplated by the Development Plan. Following the Effective Date, the Company
shall not enter into any consulting agreement or other services agreement with,
or pay any compensation to, any health care professional for any purpose related
to the Products without the prior written consent of Zimmer (which shall not be
unreasonably withheld). Zimmer shall be responsible for providing reasonable
support, assistance and consultation to the Company with respect to the Project
and shall have the right to review and approve any and all aspects of the design
of the SEEG Products and associated instrumentation and Electrode Cable Assembly
Products pertaining to the critical features identified for each such Product on
Exhibit C. The Company hereby designates [**] as its project manager for its
responsibilities in connection with the Project and Zimmer hereby designates
[**] as its project manager for its responsibilities in connection with the
Project. Either party may designate in writing to the other party an alternative
project manager at its sole discretion.

 

1.4. Efforts; Costs. Each Party will use Commercially Reasonable Efforts to
perform and complete in a timely fashion its responsibilities in connection with
the Project. Except as otherwise expressly stated in this Agreement or the
Development Plan, each Party shall be responsible for such costs and expenses
incurred by such Party in connection with the Project. For the avoidance of
doubt, Zimmer shall be responsible for all costs and expenses related to the
Commercialization of the Products in the Territory and the Company shall be
responsible for all costs and expenses related to the Development of the
Products and the submission and prosecution of all regulatory filings required
for Regulatory Approvals in the Territory; provided, however, Zimmer and the
Company acknowledge and agree that the Products for all countries in the
Territory outside of United States will be based upon the Products for which
Regulatory Approval has been received by the Company in the United States and to
the extent Zimmer or any Regulatory Authority outside of the United States
requires additional changes to the Products or additional actions or
requirements beyond the submission and prosecution of regulatory applications
for such Products in such country, then the Company and Zimmer shall negotiate
in good faith and agree to the allocation between the Parties of the costs and
expenses related such additional changes to the Products or such additional
actions or requirements. Zimmer acknowledges and agrees that all Regulatory
Approvals for the Products in the Territory will be owned by the Company.

 

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1.5. Records. The Company will maintain records of its activities under the
Development Plan in sufficient detail and in a good scientific manner
appropriate for patent and regulatory purposes, including (a) the Design History
Files, laboratory notebooks and invention disclosures in reasonable detail to
enable the preparation and submission of patent applications covering all
patentable subject matter, and (b) data and documentation (including
instructions for use, user manuals and risk analysis) sufficient in form and
substance to enable the Regulatory Filings contemplated by Section 7.2. The
records maintained by the Company shall include all information required to be
included therein by Zimmer’s quality systems.

 

1.6. Audit Rights. Zimmer will have the right, solely with respect to the
Project and the Products, at Zimmer’s sole cost and expense, upon fifteen (15)
days’ prior notice to the Company and during regular business hours, to inspect
and audit the Company’s records, facilities and operations for the purpose of
verifying that the Company is using Commercially Reasonable Efforts to develop
the Products. Zimmer shall not be permitted to exercise the audit rights set
forth in this Section 1.6 more than twice during any calendar year of the Term
(as defined below).

 

1.7. Exclusivity. During the Term, the Company and Zimmer shall be exclusive
development and commercial partners with respect to the development and
Commercialization of the Products and related components to the Products, and
the Company and Zimmer shall not (a) engage in or perform any development
activities with respect to the Products and related components to the Products,
with or for the benefit of any other Person, or (b) manufacture, market, sell or
distribute the Products and related components to the Products, to any other
person or entity except as provided under this Agreement; provided, however,
that nothing in this Section 1.7 shall prevent the Company or Zimmer from (x)
utilizing third-party contract engineering, manufacturing or other development
resources in connection with the internal development of the Products or such
related components or (y) acquiring and owning any entity engaged in the
business of developing, manufacturing, marketing, selling or distributing
electrodes or other products or technology that is similar to or competitive
with the Products; provided, however, if Zimmer acquires or directly or
indirectly owns a controlling interest in any entity engaged in the business of
developing, manufacturing, marketing, selling or distributing electrodes for the
diagnosis of epilepsy (a “Competitive Triggering Event”), the Company shall have
the right to terminate this Agreement, in the Company’s sole discretion pursuant
to the terms and conditions of Section 10.3(d) of this Agreement following such
Competitive Triggering Event provided that the Company pays to Zimmer the
Competitive Triggering Event Termination Fee.

 

1.8. Joint Development Committee.

 

(a) The Project Participants will coordinate their development activities
through a joint development committee (the “JDC”) comprising two representatives
of each Project Participant. The initial representatives of the Company will be
[**] and [**] and the initial representatives of Zimmer will be [**] and [**].
The JDC will be co-chaired by one representative of each Project Participant
selected by such Project Participant. The Project Participants will consult in
good faith regarding any changes to the individuals serving on the JDC. Subject
to reasonable advance notice, a Project Participant may invite other members of
its organization to attend a particular meeting, but any such additional
attendee shall not have any of the rights or responsibilities of a formally
appointed representative.

 

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(b) Authority. The JDC shall have the authority to approve modifications to the
Development Plan, the Regulatory Filing strategy, the Specifications and the
Other Product Specifications; otherwise, the JDC shall be a consultative, rather
than decision-making, body. For the avoidance of doubt, the JDC shall have no
authority to amend any of the terms or conditions of this Agreement or the MS
Agreement. All approvals of the JDC shall require unanimous consent; provided
that, if the JDC is unable to reach unanimous agreement on a matter within its
authority, then the Company’s CEO and a designated representative to be
identified by Zimmer from Zimmer will negotiate in good faith to decide the
matter; provided, however the Parties acknowledge and agree in the event of any
modifications to the Development Plan, the Regulatory Filing strategy, the
Specifications or the Other Product Specifications, the Parties shall revise the
deadlines set forth in Section 6.1(c) to reflect such modifications.

 

(c) Meetings. The JDC will meet in accordance with a schedule established by
agreement of the Project Participants, but no less frequently than quarterly,
from the Effective Date until the Date of the First Commercial Sale of the last
Product to achieve commercial sales, and as needed thereafter. Meetings may be
held remotely if so agreed. Each Project Participant will use Commercially
Reasonable Efforts to cause its representatives to attend the JDC meetings and
will be responsible for the expenses incurred by its own representatives in
participating in the JDC. The co-chairs will be responsible for distributing an
agenda for each meeting at least three days in advance of the meeting. Each
Project Participant will have the right to request the co-chairs to include any
matter or issue within the purview of the JDC, which requests will be
accommodated by the co-chairs to the extent feasible. The co-chairs will
alternate responsibility for generating and circulating minutes of each meeting
(which will include a summary of any actions agreed at the meeting) to each
appointed representative for review and comment. Any corrections or comments
must be submitted to the co-chairs within ten Business Days after the draft
minutes have been circulated.

 

(d) Duration. The JDC will operate until the Date of the First Commercial Sale
of the last Product to achieve a First Commercial Sale, and as needed
thereafter.

 

ARTICLE II
INTELLECTUAL PROPERTY

 

2.1. Development License Grant. In consideration of the potential benefits to
the Company by reason of the Project, during the Term, the Company hereby grants
to Zimmer a non-exclusive, royalty-free license under the IP that is owned by
the Company, under the control of the Company or to which the Company otherwise
has access and that is necessary for or otherwise useful to the Project (the
“Company Background IP”), without the right to grant sublicenses (except to its
Affiliates), for the sole purpose of conducting the Project. Such license and
any such sublicenses shall survive completion of the Project and shall continue
for the remaining Term of this Agreement and for so long as Zimmer continues to
sell or distribute any Products under this Agreement. The Company shall own and
retain all right, title and interest in and to the Company Background IP.

 

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2.2. Program IP.

 

(a) Ownership. The rights of ownership of Program IP shall be determined in
accordance with United States patent and other intellectual property laws
(regardless of where the Program IP was invented, conceived, discovered,
created, made, developed, reduced to practice or otherwise perfected or exists).
Notwithstanding the foregoing, as between Zimmer and the Company, all right,
title and interest in and to Program IP shall be determined as follows:

 

(i) Zimmer shall own all right, title and interest in all Program IP that is
invented, conceived, discovered, created, made, developed, reduced to practice
or otherwise perfected solely by one or more employees, agents or consultants of
Zimmer, its Affiliates or subcontractors (“Zimmer Program IP”);

 

(ii) the Company shall own all right, title and interest in all Program IP that
is invented, conceived, discovered, created, made, developed, reduced to
practice or otherwise perfected solely by one or more employees, agents or
consultants of the Company, its Affiliates or subcontractors (“Company Program
IP”).

 

(iii) Zimmer and the Company shall jointly own all right, title and interest in
all Program IP that is invented, conceived, discovered, created, made,
developed, reduced to practice or otherwise perfected by one or more employees,
agents or consultants of Zimmer, its Affiliates or subcontractors together with
one or more employees, agents or consultants of the Company, its Affiliates or
subcontractors (“Joint Program IP”).

 

(b) Assignment and Assistance. Each of Zimmer and the Company hereby, on behalf
of themselves and each of their respective Affiliates, employees and
contractors, assigns to one another ownership of rights, title and interest in
and to such Program IP to effect the ownership allocation set forth in Section
2.2(a). In furtherance of the foregoing, each such Party shall, upon request by
the other, promptly undertake and perform (and/or cause its Affiliates and its
and their respective contractors, employees and/or agents to promptly undertake
and perform) such further actions as are reasonably necessary for Zimmer and the
Company (as between them) to each perfect its title in any such Program IP,
including by causing the execution of any assignments or other legal
documentation, and/or providing the other Party or its patent counsel with
reasonable access to any contractors, employees or agents who may be inventors
of such Program IP.

 

(c) Rights of Use in Joint Program IP. For clarity, Zimmer and the Company shall
co-own any and all Joint Program IP with the ability to use and sublicense such
Joint Program IP for any and all purposes, in perpetuity, without the need to
account to the other (subject, in all cases, to any other applicable terms of
this Agreement).

 

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2.3. Program Patent Rights.

 

(a) Prosecution. The Company will use Commercially Reasonable Efforts to
Prosecute Program Patent Rights claiming Company Program IP of commercial
interest or importance in the Designated Jurisdictions and shall be responsible
for all costs and expenses associated therewith. The Company will use
Commercially Reasonable Efforts to Prosecute Program Patent Rights claiming
Joint Program IP of commercial interest or importance in the Designated
Jurisdictions, in consultation with Zimmer, and the Company and Zimmer shall
equally split the external costs associated therewith. At the request and
expense of the Company, Zimmer shall provide reasonable assistance in connection
with the Prosecution of Program Patent Rights claiming Joint Program IP. The
Parties shall actively consult with each other in connection with the
Prosecution of such Program Patent Rights and shall have the right to
participate in all strategic decisions and to review and comment on all filings.
The Company shall keep Zimmer informed of all material developments relating to
such Prosecution. Notwithstanding the foregoing, in the event the Company is
unwilling or unable to Prosecute Program Patent Rights as set forth in this
Section 2.3(a), the Company shall give Zimmer full control of all such
Prosecution efforts and shall assign any such Program Patent Rights to Zimmer,
after which (i) Zimmer shall bear all costs and expenses associated with the
Prosecution of such Program Patent Rights; (ii) the Company shall cooperate with
Zimmer to complete, execute, and provide to Zimmer any and all documents
necessary to facilitate such control by Zimmer, including documents sufficient
to appoint and convey powers of attorney to Prosecution counsel of Zimmer’s
choosing in each of the foregoing jurisdictions and, if necessary, to withdraw
any Prosecution counsel previously appointed by the Company; (iii) Zimmer shall
have no obligation to consult with the Company or otherwise keep the Company
informed in connection with the Prosecution of such Program Patent Rights; and
(iv) absent a request from Zimmer, the Company shall have no right to
participate in any strategic decision or to review or comment on any filings
with respect to such Prosecution.

 

(b) Zimmer Program IP. For the avoidance of doubt, Zimmer shall have the sole
and exclusive right, in its discretion, to Prosecute Program Patent Rights
contained within the Zimmer Program IP and the Company shall have no rights in
connection therewith.

 

2.4. Zimmer Distribution Licenses.

 

(a) The Company hereby grants to Zimmer and its Affiliates the exclusive right
and license under the Company IP to use, promote, market, sell, offer for sale,
distribute, import/export and otherwise Commercialize and to have others do any
of the foregoing on their behalf the Strip/Grid Products and the Electrode Cable
Assembly Products in the Territory for all uses and applications in the Field
(the “Strip/Grid Distribution License”). The Strip/Grid Distribution License
shall remain exclusive for the Strip/Grid Exclusive License Period as provided
in Section 10.2(a) unless this Agreement is terminated earlier by a Party in
accordance with the terms set forth in this Agreement. In addition to the
Strip/Grid Distribution License, the Company hereby grants to Zimmer and its
Affiliates the exclusive right and license under the Company IP to use, promote,
market, sell, offer for sale, distribute, import/export and otherwise
Commercialize and to have others do any of the foregoing on their behalf the
SEEG Products in the Territory for all uses and applications in the Field (the
“SEEG Distribution License” and, together with the Strip/Grid Distribution
License, individually, a “Zimmer Distribution License” and collectively, the
“Zimmer Distribution Licenses”). The SEEG Distribution License shall remain
exclusive for the SEEG Exclusive License Period as provided in Section 10.2(a);
provided that the SEEG Distribution License shall become non-exclusive
immediately following the sixtieth (60th) day after the Product Availability
Date for SEEG Products (the “SEEG Exclusivity Confirmation Date”), unless Zimmer
pays to the Company the SEEG Exclusivity Maintenance Fee on or prior to the SEEG
Exclusivity Confirmation Date; and provided, further, that, if (i) Zimmer timely
delivers a Design Modification Notice, and (ii) the Product Availability Date
for SEEG Products occurs on or prior to [**], the portion of the SEEG
Exclusivity Maintenance Fee consisting of the Interim Fee Bonus provided for in
Section 6.1(c)(iv) shall not be required to be paid prior to the SEEG
Exclusivity Confirmation Date, and such portion shall be payable, if earned, no
later than [**]. During the Term, the Company shall grant Zimmer and its
Affiliates access to the Intellectual Property included in the Company IP to the
extent necessary to facilitate their ability to exploit the Zimmer Distribution
Licenses.

 

6

 

 

(b) During the Term, each Zimmer Distribution License shall be exclusive, even
as to the Company itself. So long as a Zimmer Distribution License is exclusive,
the Company will not, directly or indirectly, promote, market, sell, distribute
or otherwise Commercialize the Products in the Territory for any use in the
Field, either on its own behalf or through any Affiliate or Third Party without
Zimmer’s prior written consent.

 

(c) Zimmer shall have the right to grant sublicenses under the Zimmer
Distribution Licenses, including the right to authorize its Affiliates and
Distributors to participate (each a “Subdistributor”), subject to the terms of
this Agreement, in the use, promotion, marketing, sale, distribution and
Commercialization of the Products in accordance with this Agreement and all
Applicable Laws anywhere in the Territory for any use in the Field. In the event
that any Subdistributor takes any action that would constitute a breach of the
terms of this Agreement or violates any laws relating to the sale, marketing,
promotion or distribution of the Product in any country within the Territory,
then Zimmer shall use its Commercially Reasonable Efforts to cause such
Subdistributor to remedy such breach or violation.

 

(d) The Company shall not grant distribution rights with respect to SEEG
Products to any Third Party during the SEEG Exclusive License Period, or make
any commitment or enter into any contract, license or agreement that would
conflict with, frustrate, impede or adversely impact, diminish the benefit of,
or render ineffective Zimmer’s rights under this Section 2.4(d).

 

2.5. Third Party Intellectual Property. Except as specifically provided for in
this Agreement, in a written agreement between the Company and a Third Party
existing on the date hereof, or as may be specifically agreed between the
Company and Zimmer during the Term of the Project, the Company shall not use any
third party intellectual property rights in undertaking its development efforts.

 

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2.6. Enforcement of Rights. If either Party learns of any infringement or
violation by a Third Party of any Program IP, it shall notify the other Party as
soon as practicable. Thereafter, the Parties shall consult on a course of action
with respect to such infringement or violation. Unless otherwise agreed to by
the Parties in the course of their consultations, the Company shall have the
first right to bring and control any claim, action or proceeding against such
Third Party for such infringement or violation of the Program IP (an
“Enforcement Action”) by counsel of its own choice. If the Company fails to
initiate any such Enforcement Action within the earlier of 90 days following
notice of the basis therefor or 30 days before the expiration of any applicable
time limit for bringing such Enforcement Action, then Zimmer shall have the
right to bring and control any such Enforcement action by counsel of its own
choice. If Zimmer lacks standing to bring such Enforcement Action, then the
Company shall be obligated to bring such Enforcement Action if so requested by
Zimmer. In all events, the non-controlling Party shall have the right to be
represented in any such Enforcement Action by counsel of its own choice. If the
Party bringing any such Enforcement Action is unable to initiate or Prosecute it
solely in its own name, the other Party shall join in voluntarily and shall
execute all documents necessary to enable the initiating Party to Prosecute and
maintain such Enforcement Action. In connection therewith, the Parties shall
cooperate fully and provide each other with any information or assistance
reasonably requested. Each Party shall keep the other informed of developments,
including the status of settlement negotiations. Neither Party shall settle such
Enforcement Action without the prior written consent of the other Party, which
consent shall not be unreasonably withheld, conditioned or delayed. Each Party
shall bear its own costs and expenses in connection with the Enforcement Action,
but shall be entitled to full reimbursement thereof out of any recovery or
monetary award realized in connection therewith. After such reimbursement, the
balance of any recovery or monetary award shall be allocated between the Parties
in proportion to the relative economic losses suffered by each, as determined by
the Parties in good faith.

 

2.7. Defense of Infringement Claims. If any Third Party asserts a Claim against
a Party (or any of its Affiliates or Distributors) alleging that any Product,
the use or practice of the Program IP or any activity pursuant to this Agreement
infringes, misappropriates or violates the Intellectual Property Rights of any
Third Party (any such Claim being referred to as an “Infringement Claim”), the
Party first having notice of the Infringement Claim shall promptly notify the
other Party thereof in writing specifying the facts, to the extent known, in
reasonable detail. The Company shall indemnify Zimmer with respect to
Infringement Claims pursuant to Section 8.4.

 

2.8. Use of Zimmer Trademarks. If directed by Zimmer in writing, the Company
shall place onto the Products shipped to Zimmer (or the packaging for such
Products) the designated Zimmer Trademarks and part numbers. In the event that
any Products so labeled are not delivered to Zimmer, whether due to scrap,
rejection, cancellation of orders or otherwise, the Company shall promptly
remove and destroy or, at the request of Zimmer, return to Zimmer, any and all
labels, name plates, or other Trademarks placed on the Products. The Company
shall not use the “Zimmer Biomet”, “Zimmer” or “Biomet” names or any Zimmer
Trademarks except as provided in this Agreement and in accordance with Zimmer’s
policies regarding the use of such names or Trademarks, and any use of the names
“Zimmer Biomet “, “Zimmer” or “Biomet” by the Company in labeling,
advertisements and other similar usages shall be subject to the prior written
approval of Zimmer. Upon termination of this Agreement or upon the request of
Zimmer, the Company will discontinue the use of all Zimmer Trademarks, including
the names “Zimmer Biomet”, “Zimmer” and “Biomet”, and, thereafter, will not use
any of the Zimmer names or Trademarks in any manner except as may be expressly
permitted by other agreements between the Company and Zimmer.

 

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2.9. Promotion Limitation. The Company covenants that it shall not use the
“Zimmer Biomet”, “Zimmer” or “Biomet” names or any Zimmer Trademarks, in any
advertising or promotion by the Company (whether by including reference to
Zimmer in any list of customers, advertising that its services and products are
used by Zimmer, denying or confirming the foregoing or for any other purposes)
without advance written permission from Zimmer. Notwithstanding the above, the
Company can use the “Zimmer Biomet”, “Zimmer” or “Biomet” names or any Zimmer
Trademarks, for: (a) press announcements or other communications consistent with
Zimmer’s own public announcements or regulatory filings or this Agreement; (b)
press announcements or other communications consistent with medical publications
and/or abstracts related to the Product; and (c) as required by law or
regulation.

 

2.10. Trademark License. Zimmer and its Affiliates and Distributors will have
the right to use the Company’s Trademarks associated with the Products as
required by applicable Regulatory Laws or as otherwise necessary in connection
with Zimmer’s marketing and distribution of the Products. Zimmer and its
Affiliates and Distributors shall comply with the reasonable quality control
instructions of the Company as to the form and manner in which such Trademarks
are used. Other than as expressly provided in this Agreement, no Party shall
acquire or have any right to use the name or Trademarks of the other Party
without its prior written consent.

 

2.11. Rights upon Company Insolvency. Each of the Zimmer Distribution License
and the licenses granted under Section 2.1 herein shall be deemed to be, for
purposes of Section 365(n) of the United States Bankruptcy Code (and any similar
laws of other countries), a license of rights to “intellectual property” as
defined therein. Zimmer and its Affiliates, as licensees of such rights, shall
have the rights and elections with respect thereto as specified in the United
States Bankruptcy Code (and any similar laws of other countries). If a
bankruptcy or similar proceeding is commenced by or against the Company and the
Company (or a trustee or other Person acting on its behalf) thereafter rejects
this Agreement or fails to perform all of its obligations hereunder, then Zimmer
and its Affiliates shall be entitled to retain their rights under this Agreement
(and under any agreement supplementary hereto) as such rights existed prior to
commencement of such proceeding.

 

2.12. No Reverse Engineering. The Parties agree not to reverse engineer any
Products, except to the extent permitted by this Agreement or to the extent
enforcement of the foregoing is prohibited by Applicable Law.

 

2.13. Development of Related Instruments. Zimmer shall have the sole right (at
Zimmer’s sole cost and expense) to design, Develop and Commercialize Related
Instruments itself or through third-party developers or vendors, which may
include the Company. No Intellectual Property created, discovered or developed
directly related to the design, Development or Commercialization of the Related
Instruments shall be Program IP for purposes of this Agreement and all
Intellectual Property Rights with respect thereto shall belong to Zimmer. To the
extent requested by Zimmer, the Company shall include one or more of the Related
Instruments in its Regulatory Filings and Regulatory Approvals, and Zimmer shall
provide to the Company all information reasonably requested by the Company for
the purpose of making such Regulatory Filings or obtaining such Regulatory
Approvals and with respect to such Related Instruments that are included by the
Company in any such Regulatory Filings and Regulatory Approvals, Zimmer hereby
grants to the Company a non-exclusive license to the Intellectual Property
Rights related to the Related Instruments during the Term and for a period of
nine (9) months following the expiration or termination of this Agreement.

 

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ARTICLE III
DATA PRIVACY AND SECURITY

 

3.1. Company Data Privacy and Security Program. The Company shall establish and
maintain a data privacy and security program that complies with all Applicable
Laws regarding data privacy and security and is consistent with industry
standards for privacy, confidentiality and data security in industries involving
the collection, storage and processing of Protected Data. Zimmer, together with
its outside counsel and an independent, third-party auditor, shall have the
right to review and assess the Company’s data privacy and security program to
assess its compliance with Applicable Laws. Zimmer shall not be permitted to
exercise the audit rights set forth in this Section 3.1 more than twice during
any calendar year of the Term.

 

ARTICLE IV
DISTRIBUTION

 

4.1. Marketing and Sales Activities. From and after the Product Availability
Date for each Product, Zimmer will make such Product available to its sales
force and will use its Commercially Reasonable Efforts to promote, market and
sell such Product. Notwithstanding the foregoing, Zimmer will have sole
discretion to establish the pricing and other terms and conditions of sale of
the Products to its customers.

 

4.2. Branding. The Parties acknowledge that Zimmer may establish separate
brand(s) and Trademark(s) for use and association exclusively with the Products
to be marketed and sold by Zimmer pursuant to this Agreement. Zimmer shall own
the associated Trademark(s). The Company shall be responsible for the
development, quality and regulatory efforts required in conjunction with
labeling changes for the Products required under Applicable Law as a result of
branding decisions. The Company shall cooperate as requested by Zimmer to obtain
approval of such brand names as may be required by Regulatory Laws and shall
package the Products consistent with the branding specifications for such
brand(s). Until any new Zimmer brand(s) are established and at any time
thereafter, the Parties acknowledge that Zimmer and its Affiliates and
Distributors may distribute and sell Products using the brand(s) associated with
such Products.

 

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4.3. Training, Marketing and Education Support.

 

(a) Company Training for Zimmer. Throughout the Term, the Company will provide,
for no additional consideration, (i) periodic product sales training sessions
for sales personnel of Zimmer, its Affiliates and Distributors, at times and
locations as shall be mutually agreed, (ii) a system for real-time advice
regarding the Products for Zimmer’s sales personnel, (iii) reasonable customer
and field support (including a system to respond effectively to Product
Complaints and warranty claims), and (iv) reasonable assistance in developing
training and sales/marketing literature as needed to facilitate the marketing,
sale and distribution of the Products.

 

(b) Training Compliance. All Company training sessions for Zimmer personnel and
all Product informational materials created or used by the Company with respect
thereto shall comply with all Zimmer corporate policies, practices and
procedures related to advertising, promotional and informational materials. In
addition, all surgeon education and training events and programs conducted by
either party online or in person shall comply with all Zimmer compliance
policies, practices and procedures related to arrangements with healthcare
professionals.

 

4.4. Right to Product Improvements. Zimmer shall have the right to any and all
Product Improvements developed or produced by the Company during the Term. The
Company shall promptly notify Zimmer of the completion of each Product
Improvement and shall collaborate with Zimmer to integrate such Product
Improvement into the Products.

 

4.5. [**]

 

ARTICLE V
MANUFACTURING AND SUPPLY

 

5.1. Manufacturing and Supply Agreement. On or prior to the date of the LMR
Order for the Strip/Grid Products, the Parties shall enter into a Manufacturing
and Supply Agreement in substantially the form attached hereto as Exhibit D (the
“MS Agreement”). The Parties agree to amend the MS Agreement on or prior to the
date of the LMR Order for each Product to include such additional Product as a
product to be manufactured and supplied by the Company under the MS Agreement.
Following the execution or amendment thereof, the Parties shall comply at all
times with the requirements set forth in the MS Agreement (as so amended, if
applicable). In the event of conflict between the provisions of this Agreement
and the MS Agreement (as so amended, if applicable), this Agreement shall
control.

 

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5.2. Manufacturing Permits and Approvals. At all times during the Term of this
Agreement, the Company shall obtain and maintain in full force and effect (at
the Company’s expense) all permits, certifications, approvals and licenses
required by Applicable Laws (including, as applicable, ISO certification, FDA
registration, and all other U.S. or international permits and approvals
required), and shall make all filings with Governmental Authorities, that are
necessary and/or legally required to conduct any business involving the
development, manufacture, sale, distribution or promotion of the Products and
otherwise for the performance of the Company’s duties and obligations under this
Agreement. The Company shall notify Zimmer as soon as practicable after
receiving notice of any claim or action by the FDA or other Governmental
Authority with respect to its permits, certifications or licenses that could
adversely affect the Company’s performance of its obligations under this
Agreement.

 

5.3. Quality Agreement. On the date of execution of the MS Agreement, the
Company and Zimmer shall enter into a supplier quality agreement similar to the
form Quality Agreement attached hereto as Exhibit E (the “Quality Agreement”).
Following the execution thereof, the Parties shall comply at all times with the
quality requirements set forth in the Quality Agreement. In the event of
conflict between the provisions of this Agreement and the Quality Agreement,
this Agreement shall control.

 

ARTICLE VI
FEES AND TRANSFER PRICING

 

6.1. Exclusivity Fees.

 

(a) In consideration for the exclusive distribution rights granted to Zimmer
hereunder, Zimmer shall make an initial payment to the Company in the amount of
$2,000,000 (the “Initial Exclusivity Fee”) in immediately available funds on the
tenth (10th) Business Day after the Effective Date. The Company agrees to use
the proceeds from the Initial Exclusivity Fee first, to pay expenses associated
with the Project and thereafter for general working capital purposes.

 

(b) In addition to the Initial Exclusivity Fee, in order to maintain the
exclusivity of the SEEG Distribution License, Zimmer must pay the SEEG
Exclusivity Maintenance Fee to the Company, on or prior to the SEEG Exclusivity
Confirmation Date, in immediately available funds.

 

(c) Except where Zimmer timely delivers a Design Modification Notice pursuant to
Section 1.2, if one or more of the events set forth in the table below occurs on
or before the deadline indicated for such event and the Product Availability
Date for the SEEG Products occurs on or before [**], then the Company shall
receive the additional amount indicated for such event as part of the SEEG
Exclusivity Maintenance Fee.

 

Event  Deadline   Interim Fee Bonus  [**]  [**]   [**]  [**]  [**]   [**] 

 

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Notwithstanding the foregoing, if Zimmer timely delivers a Design Modification
Notice to the Company pursuant to Section 1.2, and one or more of the events set
forth in the table below occurs on or before the deadline indicated for such
event and the Product Availability Date for the SEEG Products occurs on or
before [**], then the Company shall receive the additional amount indicated for
such event as part of the SEEG Exclusivity Maintenance Fee:

 

Event  Deadline   Interim Fee Bonus  [**]  [**]   [**]  [**]  [**]   [**] 

 

Each additional amount described in clauses (i) through (iv) of this Section
6.1(c) is referred to in this Agreement as an “Interim Fee Bonus”. For purposes
of this Agreement, each of the foregoing events shall have occurred only if the
Company has demonstrated the achievement of the event to Zimmer’s reasonable
satisfaction. Notwithstanding the foregoing, the events in Sections 6.1(c)(ii),
(iii) and (iv) shall not be deemed to be met if FDA Approval for the SEEG
Products is not received prior to the applicable deadline.

 

(d) Notwithstanding any other provision of this Agreement, if the Product
Availability Date for the SEEG Products has not occurred on or before [**],
Zimmer shall have the right to terminate the SEEG Distribution License by
delivering written notice to the Company to that effect and, upon delivery of
such notice, Zimmer shall be relieved of all of its obligations hereunder with
respect to SEEG Products, including any obligation to pay the SEEG Exclusivity
Maintenance Fee or to purchase, market, distribute or sell any SEEG Products.

 

(e) The Initial Exclusivity Fee and the SEEG Exclusivity Maintenance Fee
(including any Interim Fee Bonus(es)), once paid, are non-refundable.

 

6.2. Transfer Pricing; Initial Orders.

 

(a) Transfer Prices. Except as otherwise provided in this Section 6.2, (i) the
transfer price for each Product (other than the Electrode Cable Assembly
Products) purchased by Zimmer, or its Affiliates or Subdistributors, under the
MS Agreement or otherwise during the Term and the term of the MS Agreement will
be equal to [**] and (ii) the transfer prices for the Electrode Cable Assembly
Products shall be as set forth on Exhibit F attached hereto. No later than sixty
(60) days following the expiration of the twelve (12) month period following the
placement of the Initial Stocking Order, the parties agree to negotiate a
potential change to the calculation of the transfer price for the Products;
provided that the transfer price for the Products (other than the Electrode
Cable Assembly Products) shall not exceed [**]; and provided, further, that if
the Parties cannot agree on a change to the calculation of the transfer price
prior to the end of such 60-day period, then the transfer price shall be [**].
The transfer prices applicable for purchases by Zimmer under the MS Agreement or
otherwise will not exceed any other distributor pricing charged by the Company
for similar products. The Parties acknowledge and agree that for the purposes of
calculating [**].

 

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(b) Initial Orders. Not later than thirty (30) days following the execution of
the MS Agreement (in the case of Strip/Grid Products) and no later than thirty
(30) days following the Acceptance of all Deliverables for SEEG Products under
the Development Plan, Zimmer, or its Affiliates or Distributors, will place an
initial order or orders under the MS Agreement to purchase a sufficient number
of Strip/Grid Products or SEEG Products, as applicable, to conduct a Limited
Market Release of such Products (an “LMR Order”). Thereafter, Zimmer will have
the right with respect to each Product to place an initial stocking order (an
“Initial Stocking Order”) for such Product in a quantity determined by Zimmer in
its sole discretion to be sufficient to support the commercial launch of such
Product. The transfer price for the Initial Stocking Order shall be equal to
[**] of the transfer price as set forth in Section 6.2 above, provided, however,
the transfer prices for the Electrode Cable Assembly Products included in the
Initial Stocking Order shall be as set forth on Exhibit F attached hereto.

 

(c) [**] Reconciliation. No later than forty-five (45) days after the end of (i)
the calendar quarter in which the First Commercial Sale of a Product by Zimmer,
or its Affiliates or Distributors occurs and (ii) each calendar quarter
thereafter through the calendar quarter in which the first anniversary of the
First Commercial Sale of such Product occurs, Zimmer will prepare and deliver to
the Company a written report (the “[**] Reconciliation”), showing the [**]
during such quarterly period and a reconciliation of the transfer price for each
order, showing the difference between the transfer price paid for each order and
a transfer price equal to [**]. The Company shall have 30 days after receipt of
the [**] Reconciliation to agree or disagree with the information in the [**]
Reconciliation. In the event of a disagreement, the Parties will negotiate in
good faith to resolve the disagreement. If, based on the [**] Reconciliation as
finally agreed, the transfer price paid for the orders placed during such
quarterly period is greater than the transfer price calculated using the [**]
Reconciliation, then the Company shall pay to Zimmer the amount of such
difference; if, based on the [**] Reconciliation as finally agreed, the transfer
price paid for the orders placed during such quarterly period is less than the
transfer price calculated using the [**] Reconciliation, then Zimmer shall pay
to the Company the amount of such difference. Payments under this Section 6.2(c)
shall be made within ten (10) Business Days after the amount is finally
determined.

 

6.3. Taxes. Zimmer shall pay all sales, use and transfer taxes and other charges
arising out of the purchase and sale of the Products, including any VAT and
personal property taxes and all inspection fees and duties, applicable to the
sale and transport of the Products by Zimmer or any Subdistributors in the
Territory which are applicable thereto. The Company shall not be responsible for
any business, occupation, withholding or similar tax, or any taxes of any kind,
relating to the purchase and sale of the Products.

 

6.4. Customer Support. Zimmer shall be solely responsible for providing, and
shall provide the customers in the Territory with, all training with respect to
the Products that is necessary to support the normal use of the Products by
customers. Zimmer shall, at its cost, cause all of its sales force personnel to
become sufficiently knowledgeable and competent with respect to the Products, to
allow Zimmer to meet its customer support obligations under this Section 6.4.
The Company will provide required training on the Products at the Company’s
expense pursuant to Section 4.3 above, although Zimmer is responsible for travel
and lodging and other expenses related to attending such required training.

 

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ARTICLE VII
COMPLIANCE AND QUALITY CONTROL

 

7.1. Compliance with Laws.

 

(a) Each Party shall comply in all material respects with all Applicable Laws
that pertain to its activities under this Agreement and, except as otherwise
provided for herein, will bear the entire cost and expense of such compliance.

 

(b) To the extent the Company retains Health Care Professionals to assist with
Development of the Products, those Health Care Professionals will be engaged (i)
through a written consulting agreement that requires the Health Care
Professional to abide by the laws and regulations enumerated herein under the
definition of Applicable Laws, (ii) following completion of needs assessment and
due diligence processes, and (iii) compensated hourly at a fair market value
rate. All related compensation must be accurately recorded and reported under
the Physician Payments Sunshine Act and other Applicable Laws.

 

(c) The Company will ensure that its employees receive anti-bribery and
anti-corruption compliance training.

 

7.2. Regulatory Approvals.

 

(a) Company Responsibilities. The Company will make all Regulatory Filings and
obtain and maintain all required Regulatory Approvals (including all required
FDA Approvals) for the Products in the Designated Jurisdictions. The Company
will have primary responsibility for all communications, submissions and
interactions with Regulatory Authorities for the purpose of obtaining and
maintaining Regulatory Approvals; provided, however, that Zimmer will have the
right to (i) review and provide input into each Regulatory Filing, including the
preparation of each Regulatory Filing and the proposed indications and
instructions for use (or equivalent labeling) included in each Regulatory
Filing, (ii) require the Company to include one or more Related Instruments in
each Regulatory Filing, and (iii) participate generally in the regulatory
process at its own expense. To facilitate such participation, the Company will
(x) notify Zimmer of all planned Regulatory Filings and regulatory actions,
communications and meetings sufficiently in advance to allow Zimmer a reasonable
opportunity to review, comment and/or participate, as applicable; and (y)
provide Zimmer copies of all relevant communications, correspondence and
documents received from Regulatory Authorities promptly after receipt,
including, where applicable, copies of the following items and equivalent
information for non-U.S. jurisdictions: FDA clearance letters, 510(k)
submissions, Declarations of Conformity, ISO 13485 certification, redacted
Essential Requirements verification checklists, and any licenses or evidence of
registration of Products in its possession and control as applicable for sale in
the Territory. The Company will be responsible for all costs and expenses
relating to obtaining and maintaining Regulatory Approvals for the Products
(including, if requested by Zimmer, any Related Instruments included in the
applicable Regulatory Filing) in the Designated Jurisdictions. The Company
hereby grants to Zimmer the fully paid-up right and license to use any and all
Regulatory Approvals related to the Products in the Territory owned by or
licensed to the Company and existing as of the date of this Agreement or
obtained during the Term.

 

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(b) Material Communications. The Company will keep Zimmer informed on a regular
and timely basis of all material communications and filings with, to or from all
Regulatory Authorities relating to the Products or the Regulatory Approvals.

 

(c) Other. Zimmer will have primary responsibility for all communications,
submissions and interactions with the FDA and other applicable Regulatory
Authorities for the purpose of obtaining and maintaining regulatory approvals
for any devices or products associated with the Products, including, as
applicable, any mobile applications designed by Zimmer using information from
the Products, any Related Instruments that are not included in the Company’s
Regulatory Filings, or, to the extent relevant, other medical devices
incorporating the Products. The Company shall provide all information and
support necessary to enable Zimmer to obtain and maintain such approvals.

 

7.3. Regulatory Proceedings. The Company shall be responsible to Regulatory
Authorities throughout the Territory as the manufacturer of the Products. If
either Party receives notice of an actual or threatened inspection,
investigation, inquiry, import or export ban, product seizure, enforcement
proceeding or similar action by a Regulatory Authority with respect to a Product
or a Party’s activities in connection with a Product, it will notify the other
Party within two Business Days after its receipt of notice of the action and
will promptly deliver to the other Party, within a further one Business Day,
copies of all relevant documents received from the Regulatory Authority. The
Parties shall cooperate in response to the action, including providing
information and documentation as requested by the Regulatory Authority. If the
action primarily concerns Zimmer’s activities, then Zimmer will have primary
responsibility to respond to the Regulatory Authority; otherwise, the Company
will have primary responsibility to respond. In either case, upon request of the
responding Party, the other Party shall cooperate in good faith and provide
consulting advice and assistance with the response.

 

7.4. Product Labels. All Products will be labeled to reflect the Company as the
manufacturer and Zimmer as the distributor. The Company will work with Zimmer to
ensure Product Part numbers avoid conflicts for Zimmer. Zimmer shall have the
right to review and approve all labeling for the Products (including package
inserts/IFUs, product brochures, surgical techniques and web-site materials),
and the Company agrees to make modifications to such labeling for the Products
as reasonably requested by Zimmer. If applicable, the Company will have sole
responsibility for obtaining all necessary Product labels and for negotiating
the language of the Product labels and package insert/IFU with the applicable
Regulatory Authorities in the Territory; however, the Company will not propose
or agree to specific content without Zimmer’s prior approval.

 

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7.5. Debarment. The Company certifies that it has not and will not use in any
capacity in connection with the performance of its obligations under this
Agreement, the services of any individual or entity debarred, excluded,
suspended or disqualified by the Office of Inspector General of the Department
of Health and Human Services or otherwise deemed ineligible to participate in
any federal or state healthcare program.

 

7.6. Federal EEO and Affirmative Action Obligations. In as much as Zimmer is a
federal contractor, federal law requires that Zimmer notify the Company of its
equal employment opportunity and affirmative action obligations. This Section
7.6 applies only to the performance of this Agreement in the United States of
America. When applicable, the Company shall comply with the EO Clause in Section
202 of Executive Order 11246, as amended, which is incorporated herein by
specific reference. When applicable, the Company shall abide by the requirements
of 41 C.F.R. § 60-300.5(a). This regulation prohibits discrimination against
qualified protected veterans, and requires affirmative action by covered prime
contractors and subcontractors to employ and advance in employment qualified
protected veterans. When applicable, the Company shall abide by the requirements
of 41 C.F.R. § 60-741.5(a). This regulation prohibits discrimination against
qualified individuals on the basis of disability, and requires affirmative
action by covered prime contractors and subcontractors to employ and advance in
employment qualified individuals with disabilities.

 

7.7. Reporting. Each Party shall maintain a system of collecting and recording
Product Complaints and reportable events under Applicable Laws relating to the
Products in accordance with its standard procedures and policies in effect from
time to time and shall provide to the other Party reports of such complaints and
events within two Business Days after receipt. Each Party shall immediately
notify the other of any material information such Party learns concerning the
accuracy, performance, safety or efficacy of the Products, regardless of whether
formal reporting to any Regulatory Authority is required. The Company shall be
responsible for investigating all Product Complaints and reportable events and
reporting to Zimmer, Regulatory Authorities and customers, as appropriate;
provided, however, that Zimmer will provide reasonable assistance and
cooperation in all communications with customers. The Company will be
responsible for all post-market surveillance required by a Regulatory Authority
or Applicable Laws and for submitting to applicable Regulatory Authorities all
required reports and other materials, including annual reports, distribution
reports, product performance reports, medical device reports, safety reports and
similar reports.

 

7.8. Field Actions. If either Party in good faith determines that a Field Action
involving a Product or its labeling is warranted (whether or not required by a
Regulatory Authority), such Party will immediately notify the other Party in
writing and will advise the other Party of the reasons underlying its
determination that a Field Action is warranted. The Parties will consult with
each other as to any action to be taken in regard to such Field Action. If,
after consultation, either Party in good faith believes that a Field Action
should be undertaken with respect to a Product or its labeling, the Parties will
cooperate in carrying out the same. The Company will be responsible for all of
Zimmer’s reasonable out of pocket costs and expenses, including the cost of the
Products and the replacement cost of the Products, in the event of Field Action
with respect to any Product unless such Field Action was due to an intentional
act or omission of Zimmer. The Company will be responsible for any required
reporting to Regulatory Authorities with respect to any Field Action involving a
Product or its labeling.

 

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ARTICLE VIII
REPRESENTATIONS AND WARRANTIES; INDEMNIFICATION.

 

8.1. Mutual Representations and Warranties. Each Party hereby represents and
warrants to the other that:

 

(a) it is a corporation duly organized, validly existing and, if relevant in its
jurisdiction of organization, in good standing under the laws of its
jurisdiction of organization and has all requisite power and authority to enter
into this Agreement and to perform its obligations hereunder;

 

(b) the execution, delivery and performance by it of this Agreement and the
consummation by it of the transactions contemplated hereby have been duly
authorized and approved by all necessary corporate or equivalent action on its
part;

 

(c) this Agreement has been duly executed and delivered by it and constitutes
its legal, valid and binding obligation, enforceable against it in accordance
with its terms;

 

(d) the execution, delivery and performance by it of this Agreement and the
consummation by it of the transactions contemplated hereby do not and will not:
(i) violate any Applicable Laws; (ii) conflict with, or result in the breach of
any provision of its organizational documents; (iii) result in the creation of
any lien or encumbrance of any nature upon any property being transferred by it
pursuant to this Agreement; or (iv) violate, conflict with, result in the breach
or termination of, or constitute a default under (or event which, with notice,
lapse of time or both, would constitute a default under) any permit, contract or
agreement to which it is a party or by which any of its properties or businesses
are bound;

 

(e) no authorization, consent or approval of, or notice to or filing with, any
Person is required for the execution, delivery and performance by it of this
Agreement (excluding approvals of Regulatory Authorities as contemplated
herein); and

 

(f) neither it nor any of its Affiliates is debarred under the FFDCA or on the
U.S. Department of Health and Human Service’s List of Excluded
Individuals/Entities or the U.S. General Services Administration’s Lists of
Parties Excluded from Federal Procurement and Non-Procurement Programs.

 

18

 

 

8.2. Company Representations and Warranties. The Company hereby represents and
warrants to, and covenants with, Zimmer as follows:

 

(a) neither it nor any of its Affiliates has employed (or used any contractor or
consultant that employs) any Person who is debarred under the FFDCA or under
investigation by the FDA or other governmental authority for debarment
thereunder; and

 

(b) no health care professional holds any equity interest in the Company or any
of its Affiliates, other than in compliance with Applicable Laws;

 

(c) the Company’s operation of its business has complied (and will continue to
comply), and the Company is currently in compliance, in each case in all
material respects, with all Applicable Laws, and no event or state of facts has
occurred or exists that (with or without notice or lapse of time or both) would
constitute or result in a material violation by the Company of, or a material
failure on the part of the Company to comply with, any Applicable Law;

 

(d) neither the Company nor any Person acting on its behalf has or will,
directly or indirectly, (i) used or agree to use any funds for unlawful
contributions, gifts, entertainment or expenses relating to political or
government activity; (ii) made or agree to make, or attempt to make or agree to
make, any unlawful payment to any Government Official or violated any provision
of any Anti-Corruption Law; (iii) take(en) any action that would constitute a
violation of any Anti-Corruption Law; (iv) made or agreed to make, or attempted
to make or agree to make, any other unlawful payment; or (v) have knowledge of a
third party violating any provision of any Anti-Corruption Law on behalf of the
Company;

 

(e) neither the Company nor any Person acting on its behalf has taken or will
take any action in furtherance of making an offer, payment, gift, promise to
pay, or authorization of the giving of anything of value, to any Government
Official (or to any Person while knowing or having reason to know that all or
some portion of the consideration remitted to that Person will be offered,
given, or promised to a Government Official) for the purpose of (i) influencing
any act, decision, or failure to act by a Government Official in his or her
official capacity; (ii) inducing such Government Official to use his or her
influence to affect any act or decision of a Governmental Entity; (iii)
obtaining, retaining or directing any business; or (iv) pursuing the issuance of
any consent or any other commercial or regulatory benefits in connection with
the establishment or operation of the Company;

 

(f) the Company has obtained FDA Approval for the Strip/Grid Products and such
approval is in full force and effect on the date hereof; and

 

(g) there are no circumstances that may affect the accuracy of the foregoing
representations and warranties, including FDA or similar investigations of, or
debarment proceedings against, Company or any Person performing services or
rendering assistance relating thereto and Company will promptly notify Zimmer if
it becomes aware of any such circumstances during the Term. Further Zimmer will
have the right, solely with respect to the Project and the Products, at Zimmer’s
sole cost and expense, upon reasonable prior notice to the Company and during
regular business hours, to inspect and audit the Company’s records, facilities
and operations for the purpose of verifying its compliance with the Applicable
Law and provisions in this Paragraph.

 

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8.3. Intellectual Property Matters. The Company hereby represents and warrants
to, and covenants with, Zimmer as follows:

 

(a) Ownership. Each of the following statements are true and correct as of the
Effective Date and shall remain true and correct for the duration of the Term:
(i) the Company has sole and exclusive ownership of, or the unqualified right to
use the Company IP; (ii) the Company has not granted to any Person other than
Zimmer a license, covenant not to sue or similar right with respect to any
component of the Company IP in the Field in the Territory that would be
inconsistent with or conflict with the grant of the exclusive distribution
rights and license under this Agreement; (iii) the Company IP is free of any
lien, encumbrance, security interest, mortgage or claim of any nature; (iv)
except for payments due under the WARF License, which shall be the sole
responsibility of the Company, the Company has no obligation to make any
royalty, license or other payment in respect of the use or practice of the
Company IP, or in respect of the development, design, use, operation,
manufacture, distribution or Commercialization of the Products; and (v) all
Intellectual Property Rights required for the development, design, use,
operation, manufacture, distribution and Commercialization of the Products in
accordance with the Specifications for the Field in the Territory are included
in the Company IP.

 

(b) Right to Make Grant of License. The Company has the right to make any grants
of Company IP to Zimmer that it makes or is required to make under this
Agreement. Without limitation of the foregoing, each of the employees, agents,
consultants, contractors and others who may contribute to or participate in the
invention, discovery, creation or development of any Company IP is under a valid
and enforceable legal obligation to assign to the Company, all right, title and
interest in such Company IP. The Company shall not grant to any Person other
than Zimmer a license, covenant not to sue or similar right with respect to any
component of the Company IP that would be inconsistent with or conflict with
Zimmer’s exercise of its rights under any license granted to Zimmer hereunder in
any manner.

 

(c) Protection. The Company has administered and maintained all Patent Rights,
Trademarks, Copyrights, Industrial Designs and other components of the Company
IP, and has made and will continue to make all filings with Governmental
Agencies, whether U.S. or foreign, arising from or associated with any Company
IP or related Intellectual Property Rights to protect the Intellectual Property
of the Products in accordance with commercially reasonable intellectual property
portfolio filing and maintenance practices. The Company is current in payment of
all patent maintenance fees and similar costs related to such portfolio
maintenance. The Company has taken responsible and prudent steps to safeguard
and maintain the secrecy and confidentiality of all Proprietary Information
included in the Company Background IP.

 

(d) Non-Infringement. The use and practice of the Company IP for the
development, design, use, operation, manufacture, distribution and
Commercialization of the Products in accordance with the Specifications for the
Field in the Territory do not infringe, violate or misappropriate the
Intellectual Property Rights of any Person.

 

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(e) Claims. No Person has asserted a Claim against the Company with respect to
any of the Company IP, which Claim (i) challenges the ownership, validity or
enforceability of any of the Company IP, (ii) alleges that the Company’s use or
practice of the Company IP infringes, misappropriates or violates the
Intellectual Property Rights of any Person, or (iii) seeks to enjoin or restrain
the Company’s use or practice of the Company IP in any manner that would
interfere with the transactions contemplated by this Agreement. The Company has
no knowledge that any Person intends to assert such a Claim or that any Person
has a valid basis to do so.

 

(f) Infringement by Others. Except as disclosed by the Company to Zimmer prior
to the Effective Date, The Company has no reason to believe that any Person has
infringed, violated or misappropriated any granted patents in the Company IP as
it relates to the Product in the Field.

 

8.4. Indemnification.

 

(a) Scope.

 

(i) Each Party shall indemnify and hold harmless the other Party (and its
Affiliates and their respective shareholders, officers, directors, employees and
agents) from any liability, damage, loss, action, cause of action, tax, cost or
expense (whether or not arising out of a Third Party legal claim or action)
(including reasonable attorneys’, consultants’ and experts’ fees and expenses
and all amounts paid in investigation, defense and settlement of any of the
foregoing) (collectively, “Losses”) arising out of, in connection with or
relating to (x) any breach or inaccuracy of any representation or warranty made
by such indemnifying Party in this Agreement; (y) any noncompliance with or
breach or nonperformance of any agreement, covenant or obligation to be
performed by such indemnifying Party pursuant to this Agreement; or (z) any
violation of Applicable Law or negligence or willful misconduct in connection
with this Agreement by the indemnifying Party or any of its Affiliates or their
respective representatives, employees or agents. If the Parties have
indemnification obligations to one another in connection with a single Third
Party legal claim or action, they shall contribute to the aggregate damages and
costs in proportion to their relative responsibilities therefor based upon all
relevant equitable considerations.

 

(ii) In addition to its obligations under Section 8.4(a)(i), the Company shall
indemnify and hold harmless Zimmer (and its Affiliates and their respective
shareholders, officers, directors, employees and agents) from any Losses arising
out of, in connection with or relating to (x) any Infringement Claim and (y) any
claim of a failure to pay royalties or other amounts due to Third Parties under
license agreements between the Company and such Third Parties, including any
such claims made under or in connection with the WARF License.

 

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(b) Notice. The indemnified Party shall promptly notify the indemnifying Party
in writing and in reasonable detail of each indemnity claim, but any delay or
deficiency of such notice shall not excuse the indemnifying Party’s
indemnification obligations except to the extent that its legal position is
materially prejudiced due to the delay or deficiency.

 

(c) Defense. The indemnifying Party shall have the right to assume and control
the defense and settlement of any Third Party legal claim or action if the
predominant claims therein are covered by its indemnity, unless the Parties have
a conflict of interest with respect to such legal claim or action or the
claimant is seeking relief that, if awarded, could have an adverse effect on the
indemnified Party’s ongoing business (other than an award of money damages). If
the indemnifying Party assumes the defense, it shall employ counsel reasonably
acceptable to the indemnified Party and shall defend the claim or action with
diligence. In all events, the Party not controlling the defense shall reasonably
cooperate with the controlling Party and shall be permitted to participate in
the defense at its own expense.

 

(d) Settlement. Neither Party shall settle a Third Party legal claim or action
covered by indemnification under this Section 8.4 without the other Party’s
prior written consent, which shall not be unreasonably withheld, conditioned or
delayed, except that the Party controlling the defense shall have the right to
do so if (i) it will pay in full all monetary elements of the settlement, (ii)
the settlement does not include non-monetary elements, findings or admissions
that would be detrimental to the other Party’s ongoing business, and (iii) the
settlement includes a full release in favor of the other Party from all Losses
arising out of, in connection with or relating to such legal claim or action.

 

ARTICLE IX
CONFIDENTIALITY AND PUBLICITY

 

9.1. Scope. In the course of their activities pursuant to this Agreement, the
Parties anticipate that they may disclose Confidential Information to one
another and that either Party may, from time to time, be a disclosing Party or a
recipient of Confidential Information. The Parties wish to protect such
Confidential Information in accordance with this ARTICLE IX. The provisions of
this ARTICLE IX will apply to disclosures furnished to or received by a Party
and its agents and representatives (which may include agents and representatives
of its Affiliates). Each Party will (a) advise its employees, agents and
representatives of the requirements of this ARTICLE IX and ensure that its
employees, agents and representatives are bound by confidentiality obligations
substantially consistent with those set forth in this ARTICLE IX; and (b) be
responsible to ensure their compliance with such provisions and be responsible
for any breach of such provisions. The provisions of this ARTICLE IX will
supersede and replace any prior agreements between the Parties relating to
Confidential Information covered hereby. In addition to any other remedies
available in law or equity, the disclosing Party will be entitled to temporary
and permanent injunctive relief in the event of a breach by the recipient under
this ARTICLE IX.

 

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9.2. Definition of Confidential Information. For purposes hereof, “Confidential
Information” with respect to a disclosing Party means all Proprietary
Information, in any form or media, concerning the disclosing Party or its
Affiliates that the disclosing Party or its Affiliates furnishes to the
recipient, whether furnished before or after the date hereof, and all notes,
analyses, compilations, studies and other materials, whether prepared by the
recipient or others, that contain or reflect such Proprietary Information and
Zimmer’s Confidential Information includes all Program IP and all data,
deliverables and other information developed by either Party in connection with
this Agreement; provided, however, that Confidential Information does not
include information that (a) is or hereafter becomes generally available to the
public other than as a result of a disclosure by the recipient in violation of
this Agreement, (b) was already known to the recipient prior to receipt from the
disclosing Party as evidenced by prior written documents in its possession not
subject to an existing confidentiality obligation to the disclosing Party, (c)
is disclosed to the recipient on a non-confidential basis by a Person who is not
in default of any confidentiality obligation to the disclosing Party, or (d) is
independently developed by or on behalf of the recipient without reliance on or
use of information received hereunder. The contents of this Agreement will be
deemed to be Confidential Information of each Party.

 

9.3. Confidentiality Obligations. The recipient of Confidential Information will
(a) use such Confidential Information solely and exclusively in connection with
the exercise of its rights and the discharge of its obligations under this
Agreement, and (b) not disclose such Confidential Information without the prior
written consent of the disclosing Party to any Person other than those of its
agents and representatives who need to know such Confidential Information for
such permitted use and who are bound by appropriate written obligations of
confidentiality with respect thereto. Notwithstanding the foregoing, the
recipient of Confidential Information may disclose it to the extent necessary to
comply with Applicable Laws or with an order issued by a court or regulatory
body with competent jurisdiction; provided that, in connection with such
disclosure, the recipient will (A) provide, if allowable, reasonable advance
notice of such disclosure to the disclosing Party; (B) limit the disclosure to
the information that is legally required to be disclosed, and (C) use
Commercially Reasonable Efforts to obtain confidential treatment or an
appropriate protective order, to the extent available, with respect to such
Confidential Information. The obligations under this Section 9.3 will remain in
effect from the Effective Date through the fifth anniversary of the termination
or expiration of this Agreement. Notwithstanding the foregoing, the obligations
to protect Confidential Information identified by the disclosing Party as a
trade secret shall extend until such information becomes publicly available. In
addition to the foregoing, each Party may disclose Confidential Information
belonging to the other Party as expressly permitted by this Agreement or if and
to the extent such disclosure is reasonably necessary in the following
instances:

 

(a) filing, prosecuting, or maintaining Patents as permitted by this Agreement;

 

(b) regulatory filings for the Products that such Party has a license or right
to Develop or Commercialize hereunder in a given country or Territory;

 

(c) prosecuting or defending litigation as permitted by this Agreement;

 

(d) complying with applicable court orders or governmental regulations,
including regulations promulgated by securities exchanges and the SEC, provided
that any Party making such disclosure shall promptly notify such other Party of
such order or regulation upon the receipt thereof, and provide reasonable
assistance to such other Party in seeking confidential treatment of such
Confidential Information;

 

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(e) disclosure to its and its Affiliates’ employees, consultants, contractors,
and agents, to its licensees and sublicensees, in each case on a need-to-know
basis in connection with the Development or Commercialization of the Products in
accordance with the terms of this Agreement, in each case under written
obligations of confidentiality and non-use at least as stringent as those
herein; and

 

(f) disclosure to actual and bona fide potential investors, acquirors,
licensees, and other financial or commercial partners solely for the purpose of
evaluating or carrying out an actual or potential investment, acquisition, or
collaboration, in each case under written obligations of confidentiality and
non-use at least as stringent (except with respect to duration, which may be
shorter as long as not less than two (2) years) as those herein, provided that
if this Agreement is being disclosed the disclosing Party redacts the financial
terms and other provisions of this Agreement that are not reasonably required to
be disclosed in connection with such potential investment, acquisition, or
collaboration, which redaction shall be prepared in consultation with the other
Party.

 

Notwithstanding the foregoing, in the event a Party is required to make a
disclosure of the other Party’s Confidential Information pursuant to Section
9.3(c) or 9.3(d), it will, except where impracticable, give reasonable advance
notice to the other Party of such disclosure and use the same diligent efforts
to secure confidential treatment of such Confidential Information as such Party
would use to protect its own confidential information, but in no event less than
reasonable efforts. In any event, the Parties agree to take all reasonable
action to avoid disclosure of Confidential Information hereunder. Any
information disclosed pursuant to Section 9.3(c) or 9.3(d) shall remain
Confidential Information and subject to the restrictions set forth in this
Agreement, including the foregoing provisions of this Article IX.

 

9.4. Limitations on Obligations. Except as otherwise required by Applicable Law,
upon the termination or expiration of this Agreement, if requested by the
disclosing Party, the recipient of Confidential Information:

 

(a) will promptly return or destroy, at the recipient’s election, all
Confidential Information of the disclosing Party, including all notes or other
work product prepared by the recipient based upon or incorporating Confidential
Information of the disclosing Party;

 

(b) will not retain any copies, extracts or other reproductions, in whole or in
part, of such Confidential Information, notes or other work product; provided,
however, that the recipient will be permitted to retain (but not use) (i) one
file copy of all Confidential Information on a confidential basis to evidence
the scope of and to enforce the Party’s obligation of confidentiality under this
ARTICLE IX; and (ii) all back up electronic media maintained in the ordinary
course of business for archival purposes; and

 

(c) will certify in writing to the disclosing Party that the recipient has
complied with this Section 9.4.

 

24

 

 

9.5. Publicity. It is understood that each Party may desire or be required to
issue press releases relating to this Agreement or activities hereunder. The
Parties agree to consult with each other reasonably and in good faith with
respect to the text and timing of such press releases prior to the issuance
thereof, to the extent practicable, and not to issue any such release without
the other Party’s consent, provided that a Party may not unreasonably withhold,
condition, or delay consent to such releases by more than four (4) Business
Days, and that either Party may issue such press releases or make such
disclosures as it determines, based on advice of counsel, is required to comply
with Applicable Laws or with the rules and regulations promulgated by the SEC or
any exchange on which such Party’s securities are listed. Each Party shall
provide the other Party with advance notice of, and an opportunity to review,
legally required disclosures to the extent practicable. The Parties will consult
with each other on the provisions of this Agreement to be redacted in any
filings required by Applicable Laws; provided that each Party shall have the
right to make any such filing as it reasonably determines is required under
Applicable Laws. In addition, either Party shall be free to disclose, without
the other Party’s prior written consent, the existence of this Agreement, the
identity of the other Party and those terms of the Agreement which have already
been publicly disclosed in accordance with this Section 9.5, each of the Parties
may make internal announcements to their respective employees regarding the
transactions contemplated by this Agreement, subject to the other Party’s review
and approval of the announcing Party’s announcement, which approval shall not be
unreasonably withheld. Nothing herein shall prohibit or prevent either Party or
any of its Affiliates from disclosing any information of a nature that would
typically be provided by companies to their investors or prospective investors.

 

ARTICLE X
TERM AND TERMINATION

 

10.1. Term. The term of this Agreement (the “Term”) will begin on the Effective
Date and will remain in effect until the tenth anniversary of the date of the
First Commercial Sale of the last of the Products to achieve a First Commercial
Sale. Upon the expiration of the Term, this Agreement may be renewed upon the
mutual written agreement of the Parties. This Agreement may be terminated before
expiration of the Term only by agreement of the Parties or in accordance with
Section 10.3.

 

10.2. Term of Exclusivity.

 

(a) The license rights granted to Zimmer under the Strip/Grid Distribution
License shall be exclusive from the Effective Date until the tenth anniversary
of the date of the First Commercial Sale of Strip/Grid Products (the “Strip/Grid
Exclusive License Period”). The Strip/Grid Distribution License shall become
non-exclusive upon the expiration of the Strip/Grid Exclusive License Period.

 

(b) The license rights granted to Zimmer under the SEEG Distribution License
shall be exclusive from the Effective Date until (i) if Zimmer makes the SEEG
Exclusivity Payment prior to the SEEG Exclusivity Confirmation Date, then the
tenth anniversary of the date of the First Commercial Sale of SEEG Products; or
(ii) if Zimmer does not make the SEEG Exclusivity Payment prior to the SEEG
Exclusivity Confirmation Date, then the first day following the SEEG Exclusivity
Confirmation Date (the “SEEG Exclusive License Period”). The SEEG Distribution
License shall become non-exclusive upon the expiration of the SEEG Exclusive
License Period.

 

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10.3. Termination. This Agreement may be terminated before the end of the Term
or any renewal term as follows:

 

(a) If either Party believes the other Party is in material breach of this
Agreement, it may give written notice of such breach to the other Party, which
notice shall specify the breach in reasonable detail. If the alleged breach is
not remedied within 60 days after such written notice, the non-breaching Party
may terminate this Agreement immediately upon delivery to the other Party of a
written notice of termination. The termination right provided herein will not
constitute an exclusive remedy for the material breach.

 

(b) Either Party may terminate this Agreement by delivering written notice of
its decision to do so if the other Party is dissolved under applicable corporate
law or becomes subject to an Insolvency Event.

 

(c) Zimmer may terminate this Agreement for any reason or no reason by
delivering written notice to the Company specifying the effective date of such
termination, which notice must be provided at least 90 days prior to such
effective date.

 

(d) The Company may terminate this Agreement immediately upon delivery of
written notice to Zimmer upon the occurrence of a Competitive Triggering Event
and the payment by the Company to Zimmer of the Competitive Triggering Event
Termination Fee; provided that any such notice must be delivered and the
Competitive Triggering Event Termination Fee must be paid by the Company no
later than six (6) months following the occurrence of the Competitive Triggering
Event. Upon the termination of this Agreement pursuant to this Section 10.3(d),
Zimmer and its Affiliates and Subdistributors shall have the right, for a period
of nine (9) months after the termination of this Agreement (the “Transition
Period”), to continue to place orders (including bulk orders) and purchase
Products under the MS Agreement for sale to their respective then-existing
customers and to sell off all inventory of the Products held or purchased for
sale by Zimmer or its Affiliates or Subdistributors in the Territory during the
Transition Period and wind down the accounts for the Territory. The Company
shall continue to manufacture Products and sell Products to Zimmer pursuant to
the MS Agreement during the Transition Period. At the end of the Transition
Period, the Company shall repurchase any non-expired Products previously
purchased and not resold by Zimmer and its Affiliates and Subdistributors at a
price equal to [**].

 

10.4. Survival. The following provisions will survive termination or expiration
of this Agreement: (a) Section 2.2, relating to Program IP, Section 2.12, and
the first two sentences of Section 2.13; (b) ARTICLE VIII, relating to
representations and warranties and indemnification; (c) ARTICLE IX, relating to
confidentiality and publicity; (d) ARTICLE X, relating to termination and
post-termination rights and obligations; and (e) any provisions required for the
interpretation or enforcement of any of the foregoing.

 

10.5. Accrued Obligations. Termination or expiration of this Agreement will not
relieve any Party of any obligation that is expressly indicated to survive
termination and will be without prejudice to any rights that have accrued to the
benefit of any Party prior to such termination.

 

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ARTICLE XI
MISCELLANEOUS

 

11.1. Interpretive Conventions. Whenever the words “include,” “includes” or
“including” are used in this Agreement, they will be understood to be followed
by the words “without limitation.” Pronouns, including “he,” “she” and “it,”
when used in reference to any Person, will be deemed applicable to entities or
individuals, male or female, as appropriate in any given case. Standard
variations on defined terms (such as the plural form of a term defined in the
singular form, and the past tense of a term defined in the present tense) will
be deemed to have meanings that correlate to the meanings of the defined terms.
Article, Section and other headings contained in this Agreement are for
reference purposes only and are not intended to describe, interpret, define or
limit the scope, extent or intent of any provision of this Agreement. When a
reference is made in this Agreement to a Recital, an Article, a Section, a
Schedule, an Attachment or an Exhibit, such reference is to a Recital, Article
or Section of, or a Schedule, Attachment or Exhibit to, this Agreement, unless
otherwise indicated. All references to “dollars” or “$” will be deemed to be
references to the lawful currency of the United States.

 

11.2. Compliance; Conflicts. Each Party and its Affiliates and their respective
employees and agents will comply in all material respects with all Applicable
Laws that pertain to its activities under this Agreement and, except as
otherwise provided herein, will bear the entire cost and expense of such
compliance. The Parties will not, directly or indirectly, take any action
(including the grant of any right or the undertaking of any obligation) that is
in conflict with any provision of this Agreement.

 

11.3. Entire Agreement; Amendments. This Agreement constitutes the entire
agreement among the Parties concerning the subject matter hereof and supersedes
all previous negotiations, agreements and commitments with respect thereto,
including, without limitation, that certain Term Sheet dated February 13, 2020
entered into by and between the Company and Zimmer’s Affiliate. This Agreement
will not be amended or modified in any manner except by a written instrument
signed by duly authorized officers or representatives of each of the Parties.

 

11.4. Governing Law. Any claim or controversy relating in any way to this
Agreement will be governed by and interpreted exclusively in accordance with the
laws of the State of Indiana, without regard to the conflicts of law principles
thereof.

 

11.5. Dispute Resolution. Any claim, dispute, or controversy as to the breach,
enforcement, interpretation or validity of this Agreement (each, a “Dispute”)
will be referred to the Chief Executive Officer of the Company and the [•] for
Zimmer for attempted resolution prior to the institution of litigation. In the
event such executives are unable to resolve such Dispute within 30 days of such
Dispute being referred to them, then either Party may commence an action in the
Chosen Courts seeking resolution of the Dispute.

 

27

 

 

11.6. Jurisdiction; Court Proceedings; Waiver of Jury Trial.

 

(a) Any Claim, litigation, proceeding hearing or other action (collectively,
“Proceeding”) against any Party arising out of, in connection with or relating
to this Agreement shall be brought solely in any federal court sitting in the
Northern District of Indiana (the “Chosen Courts”) and each of the Parties
submits to the exclusive jurisdiction of the Chosen Courts for the purpose of
any such Proceeding; provided that a final judgment in any such Proceeding may
be enforced in other jurisdictions by suit on the judgment or in any other
manner provided by Applicable Law. Each Party irrevocably and unconditionally
agrees not to assert any (i) objection that it may ever have to the laying of
venue of any such Proceeding in any Chosen Court, (ii) Claim that any such
Proceeding brought in any Chosen Court has been brought in an inconvenient forum
and (iii) Claim that any Chosen Court does not have personal jurisdiction over
such Party with respect to such Proceeding.

 

(b) Each Party agrees that service of process in any Proceeding may be made by
mailing a copy thereof by registered or certified mail or by overnight courier
service, postage prepaid, to it at its address specified herein. Nothing in this
Agreement will affect the right of any Party to serve process in any other
manner permitted by Applicable Law.

 

(c) EACH OF THE PARTIES TO THIS AGREEMENT HEREBY WAIVES, TO THE FULLEST EXTENT
PERMITTED BY LAW, ANY RIGHT TO TRIAL BY JURY OF ANY ACTION (I) ARISING UNDER
THIS AGREEMENT OR (II) IN ANY WAY CONNECTED WITH OR RELATED OR INCIDENTAL TO THE
DEALINGS OF THE PARTIES, OR ANY OF THE TRANSACTIONS RELATED HERETO, IN EACH
CASE, WHETHER NOW EXISTING OR HEREAFTER ARISING, AND WHETHER AT LAW OR IN
EQUITY, BASED IN CONTRACT OR IN TORT OR OTHERWISE. EACH PARTY HEREBY FURTHER
AGREES AND CONSENTS THAT ANY SUCH ACTION SHALL BE DECIDED BY COURT TRIAL WITHOUT
A JURY AND THAT THE PARTIES MAY FILE A COPY OF THIS AGREEMENT WITH ANY COURT AS
WRITTEN EVIDENCE OF THE CONSENT OF THE PARTIES TO THE WAIVER OF THEIR RIGHT TO
TRIAL BY JURY.

 

11.7. Partial Illegality. If any provision of this Agreement or the application
thereof to either Party or any circumstances will be declared void, illegal or
unenforceable, the remainder of this Agreement will be valid and enforceable to
the extent permitted by Applicable Laws. In such event, the Parties will use
their best efforts to replace the invalid or unenforceable provision by a
provision that, to the extent permitted by the Applicable Laws, achieves the
purposes intended under the invalid or unenforceable provision. Any deviation by
either Party from the terms and provisions of this Agreement in order to comply
with Applicable Laws will not be considered a breach of this Agreement.

 

11.8. Waiver of Compliance. No provision of this Agreement will be waived by any
act, omission or knowledge of a Party or its agents or employees, except by an
instrument in writing expressly waiving such provision and signed by a duly
authorized officer of the waiving Party, which waiver will be effective only
with respect to the specific obligation and instance described therein.

 

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11.9. Notices. All notices and other communications in connection with this
Agreement shall be in writing and shall be sent to the respective Parties at the
following addresses, or to such other addresses as may be designated by the
Parties in writing from time to time in accordance with this Section 11.9, by
(i) registered or certified mail, postage prepaid, (ii) express courier service,
service fee prepaid, or (iii) electronic mail:

 

To the Company:

 

NeuroOne Medical Technologies Corporation

7599 Anagram Drive

Eden Prairie, MN 55344

Attn: Dave Rosa

Email: DaveR@N1MTC.com

 

with a copy (which shall not constitute notice) to:

 

Honigman LLP

650 Trade Centre Way, Suite 200

Kalamazoo, MI 49002

Attention: Phillip D. Torrence

Email: ptorrence@honigman.com

 

To Zimmer:

 

Zimmer, Inc.

c/o General Manager

Zimmer Biomet CMF and Thoracic LLC

1520 Tradeport Drive

Jacksonville, FL 32218

Email: brian.hatcher@zimmerbiomet.com

 

with a copy (which shall not constitute notice) to:

 

Zimmer, Inc.

345 East Main Street

Warsaw, Indiana 46580

Attn: General Counsel

Email: legal.americas@zimmerbiomet.com

 

All notices shall be deemed given and received (i) if delivered by hand,
immediately, (ii) if sent by mail, five Business Days after posting, or (iii) if
delivered by email or express courier service, the next Business Day in the
jurisdiction of the recipient.

 

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11.10. Counterparts; Electronic or Facsimile Transmission. This Agreement may be
executed in counterparts, each of which will be deemed to be an original and all
of which together will be deemed to be one and the same instrument. This
Agreement may be delivered by one or both Parties by facsimile or electronic
transmission with the same effect as if delivered personally.

 

11.11. Further Assurances. From time to time, as and when requested by either
Party, the other Party will execute and deliver, or cause to be executed and
delivered, all such documents and instruments and will take, or cause to be
taken, all such further actions as such other Party may reasonably deem
necessary or desirable to carry out the intentions of the Parties embodied in
this Agreement.

 

11.12. Jointly Prepared. This Agreement has been prepared jointly and will not
be strictly construed against either Party.

 

11.13. Assignment. Except as expressly provided hereunder, neither this
Agreement nor any rights or obligations hereunder may be assigned or otherwise
transferred by either Party without the prior written consent of the other Party
(which consent shall not be unreasonably withheld); provided, however, that
either Party may assign or otherwise transfer this Agreement and its rights and
obligations hereunder without the other Party’s consent:

 

(a) in connection with the transfer or sale of all or substantially all of the
business or assets of such Party relating to the Products to a Third Party,
whether by merger, consolidation, divesture, restructure, sale of stock, sale of
assets, or otherwise; or

 

(b) to an Affiliate, provided that the assigning Party shall remain liable and
responsible to the non-assigning Party hereto for the performance and observance
of all such duties and obligations by such Affiliate, and provided further that
if the entity to which this Agreement is assigned ceases to be an Affiliate of
the assigning Party, the Agreement shall be automatically assigned back to the
assigning Party or its successor.

 

The rights and obligations of the Parties under this Agreement shall be binding
upon and inure to the benefit of the successors and permitted assigns of the
Parties specified above, and the name of a Party appearing herein will be deemed
to include the name of such Party’s successors and permitted assigns to the
extent necessary to carry out the intent of this Section 11.13. Any assignment
not in accordance with this Section 11.13 shall be null and void.

 

11.14. Relationship of Parties. Each Party to this Agreement is an independent
contractor. Employees and agents of one Party are not employees or agents of the
other Party, will not hold themselves out as such, and will not have any
authority or power to bind the other Party to any contract or other obligation.

 

11.15. Third-Party Beneficiaries. Nothing in this Agreement, whether express or
implied, is intended to confer any rights or remedies under or by reason of this
Agreement on any Persons other than the Parties hereto and their respective
successors, assigns and Affiliates.

 

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11.16. Force Majeure. Neither Party shall be deemed to breach this Agreement to
the extent that such Party is prevented from or delayed in performing its
obligations hereunder due to any causes that are, and that would notwithstanding
the exercise of reasonable diligence be expected to be, beyond such Party’s
reasonable control (such causes, “Force Majeure Events”), but only to the extent
that (a) the effects of such Force Majeure Events upon the functions, activities
and efforts of the affected Party to perform its obligations hereunder is not
greater or more than its effects on such similar or related functions,
activities or efforts of such Party or its vendors performed in connection with
the Party’s own business and (b) the affected Party uses its Commercially
Reasonably Efforts to mitigate the effects of the Force Majeure Events,
including without limitation, by working around any constraints on such Party’s
ability to perform its obligations hereunder that arise as a result of such
Force Majeure Event (“Work-Around Efforts”). Upon any Force Majeure Event, the
affected Party shall give notice of such event as soon as reasonably practicable
to the other Party stating the extent and duration of the impact that such event
will have on its performance of its obligations hereunder and the cause thereof,
and the affected Party shall resume the performance of its obligations as soon
as reasonably practicable. Neither Party shall be liable for the nonperformance
or delay in performance of its obligations under this Agreement when such
failure is due to a Force Majeure Event, provided that the affected Party
implements any feasible Work-Around Efforts.

 

The following Exhibits form an integral part of the Agreement:

 

Exhibit A Definitions Exhibit B Development Plan Exhibit C Critical Features
Exhibit D Form of Supply Agreement Exhibit E Form of Quality Agreement Exhibit F
[**] Transfer Price

 

[remainder of page intentionally blank; signature page follows]

 

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The Parties have executed this Agreement as of the Effective Date to evidence
their agreement to the terms and provisions set forth herein.

 

Zimmer, Inc.         By:       Chad F. Phipps,
Senior Vice President         NeuroOne Medical Technologies Corporation        
By:       David Rosa,
President and Chief Executive Officer

 

[Signature page to Exclusive Development and Distribution Agreement]

 

 

EXHIBIT A

 

DEFINITIONS

 

“Acceptance” means, with respect to Deliverables, confirmation by Zimmer, acting
reasonably, that such Deliverables satisfy the applicable Acceptance Criteria.

 

“Acceptance Criteria”, with respect to any Deliverables, has the meaning set
forth in the Development Plan for such Deliverables.

 

“Adverse Risk” means any risk of an adverse effect on the Development,
procurement or maintenance of Regulatory Approval or Commercialization of a
Product.

 

“Affiliate” means, with respect to any Person, any other Person that directly or
indirectly controls, is controlled by or is under common control with such
Person. A Person shall be deemed to control another Person if such Person (i)
possesses the power to direct or cause the direction of the management, business
and policies of such Person, whether by contract or otherwise, and/or (ii) owns
fifty percent (50%) or more of the voting securities of such Person.

 

“Agreement” has the meaning set forth in the opening paragraph.

 

“Anti-Corruption Law” means the U.S. Foreign Corrupt Practices Act of 1977, as
amended, and all anti-corruption or anti-bribery Applicable Laws of any
jurisdiction where any Company directly or indirectly designs, develops,
manufactures, markets, distributes or sells products or that is otherwise
applicable to the business of the Company.

 

“Applicable Law(s)” means all applicable laws, ordinances, rules and regulations
of any kind whatsoever of any governmental (including international, foreign,
federal, state and local) or Regulatory Authority, including HIPAA and all other
data privacy and security laws and laws governing the use, disclosure and
protection of information and the U.S. Foreign Corrupt Practices Act of 1977;
the U.S. Travel Act, 18 U.S.C. § 1952; the Anti-Kickback Statute, 42 U.S.C. §
1320a-7b(b); the Physician Self-Referral Law, 42 U.S.C. § 1395nn; the U.K.
Bribery Act 2010; any applicable Law enacted in connection with, or arising
under, the OECD Convention on Combating Bribery of Foreign Public Officials in
International Business Transactions; or any other applicable Law or regulation
of any foreign or domestic jurisdiction relating to bribery or corruption.

 

“Approved Design Modification” means [**].

 

“[**]”.

 

A-1

 

 

“Business Day” means any day other than a Saturday, a Sunday or a day on which
banks in New York City are authorized or obligated by law or executive order to
remain closed.

 

“Chosen Courts” has the meaning set forth in Section 11.6(a).

 

“Change in Control Transaction” means: (a) the sale of all or substantially all
of the assets of the Company to an unrelated person or entity; (b) a merger,
reorganization, consolidation or similar transaction pursuant to which the
holders of the Company’s outstanding voting power immediately prior to such
transaction do not own a majority of the outstanding voting power of the
resulting or successor entity (or its ultimate parent, if applicable)
immediately upon completion of such transaction; or (c) the sale of all of the
stock of the Company to an unrelated person or entity.

 

“Claim” means any and all manner of claims, actions, suits, damages, demands and
liabilities whatsoever in law or equity, whether known or unknown, liquidated or
unliquidated, fixed, contingent, direct or indirect.

 

“Commercialize” or “Commercialization” means the conduct of all activities
undertaken before and after Regulatory Approval relating to the promotion,
sales, marketing, medical support, and distribution (including importing,
exporting, transporting, customs clearance, warehousing, invoicing, handling,
and delivering Products to customers) of Products in the Field, including sales
force efforts, detailing, advertising, market research, medical education and
information services, marketing, sales force training, and sales (including
receiving, accepting and filling Product orders) and distribution.

 

“Commercially Reasonable Efforts” means, with respect to a Party and its
obligations under this Agreement, those commercially reasonable efforts and
resources consistent with the usual practices of a similarly situated company
for the development and commercialization of a product originating from its own
research and development department without a royalty obligation to others,
which is at a similar stage of research, development, or commercialization,
taking into account that product’s profile of efficacy and safety; proprietary
position, including patent exclusivity; regulatory status, including anticipated
or approved labeling and anticipated or approved post-approval requirements;
present and future market and commercial potential, including competitive market
conditions (but not taking into account any payment owed to the other Party
under this Agreement), and all other relevant factors, including technical,
legal, scientific and/or medical factors.

 

“Company” has the meaning set forth in the opening paragraph.

 

“Company Background IP” has the meaning set forth in Section 2.1.

 

“Company IP” means, collectively, the Company Background IP, the Company Program
IP and all rights of the Company in the Joint Program IP (which, for the
avoidance of doubt, does not include any rights of Zimmer in the Joint Program
IP).

 

“Company Program IP” has the meaning set forth in Section 2.2(a)(ii).

 

A-2

 

 

“Competitive Triggering Event” has the meaning set forth in Section 1.7.

 

“Competitive Triggering Event Termination Fee” means [**].

 

“Confidential Information” has the meaning set forth in Section 9.2.

 

“Copyrights” means all rights in original works of authorship fixed in any
tangible medium of expression under the copyright laws of the United States or
any other country (and including all rights accruing by virtue of bilateral or
international copyright treaties and conventions), including, but not limited
to, all renewals, extensions, reversions or restorations of copyrights now or
hereafter provided for by law and all rights to make applications for copyright
registrations and recordations, regardless of the medium of fixation or means of
expression.

 

“Deliverables” means, with respect to a Product, the Deliverables for such
Product set forth in the Development Plan.

 

“Design History File” means, with respect to any Product, each of the following
(i) design control process and revision, (ii) design and development plan, (iii)
user needs / intended uses / design inputs, DCTM (inputs), (iv) design review I
meeting minutes and attachments, (v) design outputs, DCTM (outputs), (vi) design
review II meeting minutes and attachments, (vii) design verification protocols /
reports, (viii) design validation protocols / reports, (ix) design verification
/ validation, DCTM (complete), (x) design review III meeting minutes and
attachments, (xi) additional design review minutes and attachments (if
applicable), (xii) final responses to design review observations, (xiii) risk
management file, (xiv) usability engineering file, (xv) design transfer
activities (specification review and checklist), (xvi) design transfer
checklist, (xvii) design closure checklist and (xviii) the information required
to be created and/or maintained under the Company’s SOP-01004, as amended from
time to time.

 

“Designated Jurisdictions” means (a) the United States and (b) any jurisdictions
other than the United States where Zimmer determines, after consultation with
the Company, to market and sell one or more Products.

 

“Development” or “Develop” means any act or process for the purposes of (i)
creating or causing something to be created; or (ii) making something more
advanced. For clarity, Development does not include marketing or sales of a
commercial product.

 

“Development Plan” has the meaning set forth in Section 1.2.

 

“Distributor” means a Third Party that markets, distributes, promotes and/or
sells a Party’s products under a contractual arrangement with the Party.

 

“Effective Date” has the meaning set forth in the opening paragraph.

 

“Electrode Cable Assembly Products” means an assembly consisting of EEG cables
and a ZIF connector box, which serves to connect cortical electrodes or SEEG
electrodes to an EEG recording headbox.

 

A-3

 

 

“Enforcement Action” has the meaning set forth in Section 2.6.

 

“Exclusivity Fees” has the meaning set forth in Section 6.1(b).

 

“FDA” means the United States Food and Drug Administration and any successor
agency.

 

“FDA Approval” means, with respect to any Product, clearance by the FDA of a
510(k) application for such Product.

 

“FFDCA” means the United States Federal Food, Drug, and Cosmetic Act, 21 U.S.C.
301, et. seq., as amended, and the rules, regulations, guidance, guidelines and
requirements promulgated or issued thereunder.

 

“Field” means neurosurgery.

 

“Field Action” means any action by a Party that meets the criteria of “recall,”
“correction,” or “removal” or similar field or customer action as defined by
applicable Regulatory Law.

 

“Final Bonus Deadline” means (a) if Zimmer timely delivers a Design Modification
Notice, then [**]; and (b) if Zimmer does not timely deliver a Design
Modification Notice, then [**].

 

“First Commercial Sale” means the first commercial sale by Zimmer or its
Affiliates on an arms’ length basis to an end user of a Product in any country
following receipt of Regulatory Approval to do so. For avoidance of doubt, sales
for purposes of test marketing (including a Limited Market Release), sampling,
or promotion shall not constitute a First Commercial Sale.

 

“Force Majeure Events” has the meaning set forth in Section 11.16.

 

“Governmental Authority” means any country in which any of the Products is
manufactured, marketed, sold, tested, investigated or otherwise regulated, and
all states or other political subdivisions thereof and supranational bodies
applicable thereto, including the European Union, and all agencies, commissions,
officials, courts or other instrumentalities of the foregoing.

 

“Governmental Entity” means any:

 

(i) U.S. federal, state, local or municipal government or non-U.S. government or
subdivision thereof;

 

(ii) governmental or quasi-governmental authority of any nature (including any
governmental agency, branch, department, official, instrumentality or entity and
any court or other tribunal);

 

(iii) multi-national organization or body; or

 

(iv) body exercising, or entitled to exercise, any administrative, executive,
judicial, legislative, police, regulatory or taxing authority or power.

 

A-4

 

 

“Government Official” means any (i) officer, employee or agent of any
Governmental Entity; (ii) any official, employee or agent of a public
international organization; (iii) any Person acting in an official capacity on
behalf of such government, instrumentality or public international organization;
(iv) any political party official or candidate for political office; (v) a
member of a royal family; or (vi) any officer or employee of a government-owned
or controlled enterprise, company or organization. In many instances, Health
Care Professionals who work at or are otherwise affiliated with public hospitals
or universities may be considered Government Officials.

 

“Health Care Professional” means an individual, entity, or employee of such
entity, within the continuum of care of patients, which may purchase, lease,
recommend, use, prescribe, or arrange for the purchase or lease of medical
device products and services.

 

“HIPAA” means the Health Insurance Portability and Accountability Act of 1996,
as amended, and the rules and regulations implementing the same.

 

“Industrial Designs” means all features of shape, configuration, pattern,
ornament and the like that are or can be registered as designs or industrial
designs under Applicable Laws and all applications, registrations and renewals
in connection therewith.

 

“Infringement Claim” has the meaning set forth in Section 2.6.

 

“Initial Exclusivity Fee” has the meaning set forth in Section 6.1(a).

 

“Initial Stocking Order” has the meaning set forth in Section 6.2(b).

 

“Insolvency Event” means that the Party has (i) commenced a voluntary proceeding
under any insolvency law, or (ii) had an involuntary proceeding commenced
against it under any insolvency law which has continued undismissed or unstayed
for 60 consecutive days, or (iii) had a receiver, trustee or similar official
appointed for it or for any substantial part of its property, or (iv) made an
assignment for the benefit of creditors, or (v) had an order for relief entered
with respect to it by a court of competent jurisdiction under any insolvency
law. For purposes hereof, the term “insolvency law” means any applicable
bankruptcy, insolvency or other similar law now or hereafter in effect.

 

“Intellectual Property” means Patent Rights, Copyrights, Trademarks, Industrial
Designs, and Proprietary Information.

 

“Intellectual Property Rights” means all forms of legal rights and protections
that may be obtained under Applicable Laws for Intellectual Property.

 

“Interim Fee Bonus” has the meaning set forth in Section 6.1(c).

 

“IP” means Patent Rights and Know-How.

 

“JDC” has the meaning set forth in Section 1.8.

 

“Joint Program IP” has the meaning set forth in Section 2.2(a)(iii).

 

A-5

 

 

“Know-How” means information and materials (including but not limited to ideas,
discoveries, improvements, inventions, know-how, trade secrets, processes,
methods, protocols, formulas, data and designs), whether patentable or not, that
are in the possession or under the control of a Party and are not generally
known or publicly available.

 

“Limited Market Release” means, with respect to a Product, the sale or transfer
of such Product by Zimmer or its Affiliates or Distributors to one or more Third
Parties or end-users to conduct the initial clinical cases. For context, this
occurs in a limited number of centers and patients over a limited time
(estimated twenty-five (25) patients over three (3) months.

 

“LMR Order” has the meaning set forth in Section 6.2(b).

 

“Losses” has the meaning set forth in Section 8.4(a).

 

“Medical Device Tax” means an excise tax on the sale of certain medical devices
by the manufacturer or importer of the device imposed by Section 4191 of the
Internal Revenue Code of 1986, as amended.

 

[**].

 

“Other Product Specifications” means, with respect to any Product, the
specifications and requirements for the Development of such Product as set forth
in Exhibit B or as otherwise determined by the JDC by amendment of the
Development Plan in accordance with Section 1.8.

 

“Party” or “Parties” has the meaning set forth in the opening paragraph.

 

“Patent Rights” means patents and patent applications, including (i)
certificates of invention and applications therefor; (ii) divisionals,
continuations, continuations-in-part, reissues, renewals, substitutions,
registrations, re-examinations, post-grant reviews, revalidations, extensions,
supplementary protection certificates, and the like of any of the foregoing; and
(iii) foreign equivalents of any of the foregoing.

 

“Person” means a natural person, a corporation, a partnership, a trust, a joint
venture, a limited liability company, any Governmental Authority, or any other
entity or organization.

 

“Proceeding” has the meaning set forth in Section 11.6(a).

 

“Product Availability Date” means, with respect to a Product, the first date on
which all of the following have occurred: (a) FDA Approval of the Product has
been received, (b) the MS Agreement has been entered into or amended to provide
for the manufacturing and supply of the Product by the Company; (c) Zimmer has
placed the LMR Order for the Product under the MS Agreement, and (d) the units
of the Product included in the LMR Order have been received and accepted by
Zimmer following inspection as contemplated by the MS Agreement.

 

“Product Complaint” means any written, electronic or oral communication that
alleges deficiencies related to the identity, quality, durability, reliability,
safety, efficacy or performance of any Product, including actual or suspected
product tampering, contamination, mislabeling or misformulation.

 

A-6

 

 

“Product Improvement” means any changes, optimizations or improvements to any
Product or any of its components, whether or not patentable or subject to a
claim of copyright; provided, however, Product Improvements do not include any
therapeutics devices or products used for treatment.

 

“Products” means Strip/Grid Products, SEEG Products and Electrode Cable Assembly
Products, and “Product” means any of them.

 

“Product Transaction” has the meaning set forth in Section 4.5.

 

“Program Copyrights” means all Copyrights authored by or on behalf of a Party or
its Affiliates or subcontractors in the course of the Project.

 

“Program IP” means all Program Copyrights, Program Know-How and Program Patent
Rights.

 

“Program Know-How” means all Know-How invented, conceived, discovered, created,
made, developed, reduced to practice or otherwise perfected in the course of the
Project.

 

“Program Patent Rights” means all Patent Rights that claim or disclose Program
Know-How.

 

“Project” has the meaning set forth in Section 1.1.

 

“Project Participant” means each of Zimmer and the Company.

 

“Proprietary Information” means a Party’s trade secrets, know how, business
plans, manufacturing processes, source code, clinical strategies, product
specifications, scientific data, market analyses, formulae, designs, training
manuals and other non-public information (whether business, financial,
commercial, scientific, clinical, regulatory or otherwise) that the Party treats
as proprietary and uses commercially reasonable efforts to protect.

 

“Prosecute” means, in relation to any Patent Rights, (i) to prepare and file
patent applications (including re-examinations or re-issues thereof) and to
represent applicant(s) or assignee(s) before relevant patent offices or other
relevant authorities during examination, re-examination and re-issue thereof in
appeal processes and interferences or any equivalent proceedings, (ii) to secure
the grant of any Patent Rights arising from such patent applications, (iii) to
maintain in force any issued Patent Right (including through payment of any
relevant maintenance fees), and (iv) to make all decisions with regard to any of
the foregoing activities. “Prosecution” has a corresponding meaning.

 

“Protected Data” means information protected by Applicable Laws, including but
not limited to all data related to patients, all protected health information,
as defined by HIPAA, personal data as defined by the General Data Protection
Regulation, and any other personal and identifiable data that is produced,
analyzed, collected or stored using or within Products, regardless of the form
or location of the storage, provided that such Protected Data was made available
in accordance with Applicable Laws for use by the Company and/or Zimmer.

 

A-7

 

 

“Quality Agreement” has the meaning set forth in Section 5.3.

 

“Regulatory Approval” means, with respect to any country or region, any
approval, product and establishment license, registration or authorization of
any Regulatory Authority required for the manufacture, use, storage,
importation, exportation, transport, distribution or sale of the Product in such
country or region.

 

“Regulatory Authority” or “Regulatory Authorities” means, with respect to any
country or jurisdiction, any Governmental Authority, entity or agency involved
in granting regulatory approval for the manufacture, marketing, sale,
reimbursement and/or pricing of the Product, or in administering Regulatory Laws
in that country or jurisdiction, including the FDA in the United States.

 

“Regulatory Filings” means all applications, dossiers, notifications, requests
and other documents that may be filed with a Regulatory Authority seeking
approval to engage in development, manufacturing or Commercialization activities
with respect to the Product or seeking any regulatory designation or status with
respect to the Product, as well as all supplements and amendments to the
foregoing.

 

“Regulatory Laws” means all Applicable Laws governing the import, export,
testing, investigation, manufacture, marketing or sale of a product, or
establishing recordkeeping or reporting obligations for product complaints or
adverse events, or relating to product recalls or similar regulatory matters.

 

“Related Instruments” means a ruler, a stylet, drill bits, a driver and a
coagulator to be used with the SEEG Products.

 

“ROFN Notice” has the meaning set forth in Section 4.5.

 

“ROFN Period” has the meaning set forth in Section 4.5.

 

“SEEG Distribution License” has the meaning set forth in Section 2.4(a).

 

“SEEG Exclusive License Period” has the meaning set forth in Section 10.2(a).

 

“SEEG Exclusivity Confirmation Date” has the meaning set forth in Section
2.4(a).

 

“SEEG Exclusivity Maintenance Fee” means (a) if the Product Availability Date
for the SEEG Products occurs on or before [**], then $[**], plus the amount of
any Interim Fee Bonuses earned pursuant to Section 6.1(c), including any such
Interim Fee Bonus earned after [**] pursuant to Section 6.1(c)(iv) following the
delivery of a Design Modification Notice; (b) if the Product Availability Date
for the SEEG Products occurs after [**], but on or before [**], then $[**], plus
if Zimmer timely issues a Design Modification Notice, any Interim Fee Bonus
earned pursuant to Section 6.1(c)(iv); (c) if the Product Availability Date for
the SEEG Products occurs after [**], but on or before [**], then $[**]; and (d)
if the Product Availability Date for the SEEG Products occurs after [**], then
$[**].

 

A-8

 

 

“SEEG Products” means depth electrodes of any size or configuration, consisting
of implants placed into the brain for monitoring or mapping the subsurface
levels of the brain for the surgical diagnosis of neurological conditions,
including epilepsy, together with anchor bolts, caps and associated
instrumentation; provided, however, SEEG Products do not include any
therapeutics devices or products used for treatment.

 

“Specifications” means, collectively, (i) the Company’s design and functionality
specifications relating to the Products in the Company’s sales literature and
other Product documentation made available to Zimmer, and (ii) any
specifications for manufacturing, testing, storing, packaging, shipping or
labeling the Products set forth in any approved application for Regulatory
Approval and any supplements and amendments thereto.

 

“Strip/Grid Distribution License” has the meaning set forth in Section 2.4(a).

 

“Strip/Grid Exclusive License Period” has the meaning set forth in Section
10.2(a).

 

“Strip/Grid Products” means cortical electrodes (strips and grids) of any size
or configuration, consisting of implants placed onto the surface of the brain
for monitoring or mapping surface levels of the brain for the surgical diagnosis
of neurological conditions, including epilepsy; provided, however, Strip/Grid
Products do not include any therapeutics devices or products used for treatment.

 

“Subdistributor” has the meaning set forth in Section 2.4(c).

 

“Taxes” means any and all federal, state and local taxes, including the Medical
Device Tax, excise or gross receipts taxes, personal property taxes, customs,
duties or levies, and any foreign taxes.

 

“Term” has the meaning set forth in Section 10.1.

 

“Territory” means the entire world.

 

“Third Party” means Persons other than the Parties or Affiliates thereof.

 

“Trademarks” means all trademarks, service marks, trade dress, logos, labels,
domain names, websites and trade names, together with all translations,
adaptations, derivations and combinations thereof (including all goodwill
associated therewith), and all applications, registrations and renewals in
connection therewith.

 

“Transition Period” has the meaning set forth in Section 10.3(d).

 

“WARF License” means that certain Amended and Restated Exclusive Start-Up
Company License Agreement, dated January 21, 2020 entered into by and between
the Company and Wisconsin Alumni Research Foundation, as amended, restated,
supplemented or otherwise modified from time to time.

 

“Work-Around Efforts” has the meaning set forth in Section 11.16.

 

“Zimmer” has the meaning set forth in the opening paragraph.

 

“Zimmer Distribution License(s)” has the meaning set forth in Section 2.4(a).

 

“Zimmer Program IP” has the meaning set forth in Section 2.2(a)(i).

 

 

 

A-9