Eagle Medical Packaging - PATH-MSA-IP - 5-Jan-2022, Rev01

Master Services & IP Agreement Contract #EM2022-YYY
MASTER SERVICES & INTELLECTUAL PROPERTY AGREEMENT

This MASTER SERVICES and INTELLECTUAL PROPERTY LICENSE AGREEMENT (this “Agreement”) is
made and entered into effective as of September 1, 2021 (the “Effective Date”) by and between EAGLE MEDICAL
PACKAGING STERILIZATION, INC. (LICENSOR), a California corporation, with a place of business at 2921
Union Rd., Paso Robles, CA 93446 (hereinafter referred to as “Licensor”), and ___________________________
(Hereinafter “PURCHASER/LICENSEE ”), with place of business at
_______________________________________ (hereinafter referred to as “PURCHASER/LICENSEE”).
PURCHASER/LICENSEE and only its immediate subsidiaries added as an additional party for which Services (as
defined below) are to be performed hereunder in accordance with the terms set forth herein are referred to herein
individually as a " PURCHASER/LICENSEE Affiliate" and collectively as “PURCHASER/LICENSEE”. For the
purposes of this Agreement, the term “Affiliate” shall mean any corporation, company or other entity controlled by
PURCHASER/LICENSEE, or under common control by PURCHASER/LICENSEE of more than fifty percent
(50%) of the shares of the subject entity, wherein PURCHASER/LICENSEE is entitled to vote in the election of
directors (or, in the case of an entity that is not a corporation, for the election of the corresponding managing
authority) or more than fifty percent (50%) interest in the income of such entity. An entity shall be deemed to be an
Affiliate only so long as such PURCHASER/LICENSEE control exists. PURCHASER/LICENSEE and Licensor
are referred to herein collectively as the “Parties” and individually as a “Party”.
WHEREAS, Licensor has expertise in packaging services, packaging design support, assembly and
sterilization. Additionally, Licensor has vast experience in the validation, performance testing, and
mechanics of sealing of both thermoformed blister-tray sterile barrier systems and pouch systems both
breathable and of hermetically sealed types;
WHEREAS, PURCHASER/LICENSEE desires Licensor to perform certain services in the
production, formatting, publication and delivery of the PATH System Intellectual Property
(Hereinafter “IP or The IP”), subject to the terms and conditions set forth herein; and
WHEREAS, PURCHASER/LICENSEE wishes to obtain a non-exclusive license to use The IP Rights,
including, with limitations as specified herein, the Marks, in connection with the promotion of
PURCHASER/LICENSEE ’s relationship with Licensor or its affiliates, in connection with The IP,
and Licensor is willing to grant to PURCHASER/LICENSEE a non-exclusive license to use The IP,
including, with limitation, the data contained therein for purposes of submission to a Regulatory Entity
or Notified Body, provided that PURCHASER/LICENSEE agrees to comply (and cause its controlled
PURCHASER/LICENSEE Affiliates to comply) with the terms and conditions of this Agreement.
WHEREAS, it is the intention of the Parties to establish this Agreement to govern the respective rights,
duties and obligations of the Parties.
NOW THEREFORE, in consideration of the foregoing and the promises, covenants agreements
hereinafter set forth and in further consideration of certain other valuable consideration the receipt and
sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
1. Services.
1.1. Statements of Work. Because of the geometric specificity of the PATH-System for pre-validated
packaging and the concomitant limitations therein, for each specific Module and size, purchased by
PURCHASER/LICENSEE Party, including data package assembly, production, publication,
verification and delivery services from Licensor under this Agreement, an individual statement of work
(“SOW”) in a mutually agreed upon format (see Exhibit A), shall be executed and delivered on behalf
of the applicable PURCHASER/LICENSEE Party to Licensor. Upon mutual acceptance and execution
of such an SOW, if so executed by Licensor, it shall be binding on the Parties. Each SOW will set forth
the detailed services to be performed thereunder (the "Services"), the detailed specification of the
PATH-System Module purchased and the pricing for included non-exclusive license and use of The IP
and such Services as shall otherwise be subject to the terms and conditions of this Agreement, which
are hereby incorporated into each SOW. Licensor shall perform only those Services that are described
in an approved SOW. Unless otherwise provided in an SOW, (a) all Services performed thereunder
shall be performed solely by Licensor employees, its affiliates or, subject to Section 1.4 below, selected
contractors, and (b) Licensor shall furnish, at Licensor’s own expense, all materials, equipment, tools
and supplies necessary to perform the Services. The PURCHASER/LICENSEE Party shall specify in
each SOW its designated representative for the specification, approval and acceptance of the Services to
be provided under the applicable SOW, and Licensor shall designate its project manager.
It is acknowledged by the PARTIES that under known globally recognized international standards,
validated items relating to the safety and efficacy of a medical device, its accessories, packaging or
processing methods, including sterilization, it is understood that such systems cannot be modified, or
any such validations as has been performed and used in the submission for clearance to a notified
regulatory body or national agency (FDA, EU-MDD, etc.), are then rendered invalid as a result of such
modification(s). Thus, PURCHASER/LICENSEE Party acknowledges the unmodifiable nature of The
IP and the physical embodiment of The IP, as necessary requirement for the alignment of
PURCHASER/LICENSEE device embodiment(s) and there subsequent adoption via Engineering
Rationale as a combined system that is considered Validated according to The IP as supplied by
Licensor to PURCHASER/LICENSEE .
1.2. No Change Orders. The applicable PURCHASER/LICENSEE Party acknowledges, understands and
hereby commits to a “NO CHANGE ORDER” policy for the Services and IP specified in any SOW for
the PATH-System. Change requests are further defined in §1.3., below. All such changed Services shall
be performed pursuant to the terms of this Agreement and the applicable SOW.
1.3. Program Conversion in Lieu of Change Order(s)
If PURCHASER/LICENSEE, makes determination, after initiation and purchase of PATH-System
Module(s), but before delivery of actual digital information, that such purchased Module(s) item(s) are
unable to meet the requirements of PURCHASER/LICENSEE, PURCHASER/LICENSEE has the option
to request refund of payment for Module(s) item(s) not received. For potential refund approval detailed
server to server record of non-transmission is required. Upon digital confirmation of delivery of
Module(s) item(s) data packages, PURCHASER/LICENSEE acknowledges that no simple method exists
to guarantee non-proliferation of digital information outside the control of Licensor, and thus can no
longer apply for refund of payment. However, Should customer determine that, after receipt of such
Module(s) item(s) digital data package(s), that such Module(s) item(s) are, insufficient to meet
PURCHASER/LICENSEE’S requirements, Licensor shall provide a conversion option to a traditional
package design and validation program (“Traditional Program”), for which Licensor shall create a draw-
down account for the total value of Module(s) item(s) purchased by PURCHASER/LICENSEE, from
which Licensor shall draw funds toward completion of a Traditional Program as specified by
PURCHASER/LICENSEE. Licensor shall provide a Fixed Price, Traditional Program quotation, that
provides PURCHASER/LICENSEE with an initial understanding of total costs to complete such a
packaging design, test, and validation program. Dependent on the number, type and overall scope of
enjoined Change Order(s) initiated by PURCHASER/LICENSEE, quoted costs may be exceeded and
such excursions shall similarly be documented and drawn down by Licensor to complete the Traditional
Program. Any remaining funds in the draw-down account, at the completion of Traditional Program
validation, shall be refunded to PURCHASER/LICENSEE, along with the accounting of quoted costs,
included change orders and associated fees for the Traditional Program completion. Disagreements
leading to disputes or claims shall be addressed and in compliance with sections; 2., 5., 13., and 14..
1.4. Additional Services. Any PURCHASER/LICENSEE Party may, at any time and in its sole discretion,
request that Licensor respond to a request for proposal for services that are beyond the scope specified
within any existing SOW. In the event that such PURCHASER/LICENSEE Party elects to retain
Licensor to perform any such additional services, the Parties agree that a new SOW or independent
quotation, shall be prepared and executed by authorized representatives of both the applicable
PURCHASER/LICENSEE Party and Licensor. Upon execution of any new SOW, the definition of the
term “Services” shall be deemed amended to include the activities set forth in the new SOW or executed
Purchase Order. All such additional Services shall be performed pursuant to the terms of this Agreement
and the applicable SOW. If executed under Purchase Order, Licensor Medical Packaging Sterilization
Standard Terms and Conditions shall apply.
1.5. Subcontractors. Licensor shall not subcontract, in whole or part, any of its rights or obligations to The
IP under this Agreement. Any additional Services specifically provided in an applicable SOW, may be
subcontracted, with express written agreement by PURCHASER/LICENSEE. Any subcontract for which
PURCHASER/LICENSEE issues its written consent shall be in such form and substance as will not
create any relationship, contractual or otherwise, between the subcontractor (“Subcontractor”) and
PURCHASER/LICENSEE and will not permit Subcontractor to pass through to
PURCHASER/LICENSEE any claim of Subcontractor against Licensor. Licensor shall be solely
responsible for the job performance, actions and/or omissions of the Subcontractor employees in
connection with the Subcontractor performance under this Agreement. Licensor shall include in each
subcontract agreement terms and conditions consistent with the intent of this Agreement.
2. Acceptance and Rejection of Services.

2.1. Acceptance. Licensor acknowledges that a “sight unseen” purchase of PATH Module(s) may be a
potential inhibitor for some uninitiated entities. Therefore, PURCHASER/LICENSEE shall be provided
three options, any or all of which may be exercised at PURCHASER/LICENSEE discretion, to either:
(a) be provided with a sample protocol demonstrating the quality and content of the PATH Module(s)
under consideration for purchase and may choose to accept The IP and Services thereupon; and/or
(b) Licensor shall make available, at its Headquarters in Paso Robles, CA an actual physical hard-copy of
all PATH System Module(s) under consideration for purchase that may be physically inspected by a
designated representative of PURCHASER/LICENSEE for review, prohibiting photo-reproduction or any
digital copying mechanism from capturing information during such review, and
PURCHASER/LICENSEE may choose to accept The IP and Services thereupon; OR
(c) PURCHASER/LICENSEE shall make a non-refundable deposit, and be provided with a Sample
Portion of the digital data set, demonstrating the quality and content of the PATH Module(s) under
consideration for purchase and may choose to accept The IP and Services thereupon.
Upon completion of review by PURCHASER/LICENSEE of PATH Module(s) under consideration,
PURCHASER/LICENSEE shall sign the Irrevocable Acceptance Form, supplied by Licensor, and submit
copy thereof to Licensor via secure upload portal, express mail service or registered U.S. Mail Service.
PURCHASER/LICENSEE shall be required to supply a minimum of 12 functional (although cosmetic

defects are acceptable), actual devices intended for patient use, that are “Substantially Equivalent” devices
to Licensor which shall undergo preliminary drop-testing and vibration simulation testing, per ASTM
standard. Licensor recommends that PURCHASER/LICENSEE attach the technical reports of this testing
supplied by Licensor to the Adoption Rationale portion of any submission that PURCHASER/LICENSEE
makes to a Notified Body or Regulatory Governmental Entity.
2.2. Rejection. In the event that PURCHASER/LICENSEE notifies Licensor that the PATH Module(s)
under consideration, are insufficient or otherwise has determined that the PATH Module(s) under
consideration, are not usable by PURCHASER/LICENSEE, Licensor shall, retain any non-refundable
deposit monies paid by PURCHASER/LICENSEE for digital data package samples.
PURCHASER/LICENSEE shall have ten (10) business days after remittance of Irrevocable Acceptance
Form, in which to make any petition to Licensor for consideration of refund of any monies paid beyond
non-refundable deposit monies. In no event shall PURCHASER/LICENSEE be allowed to retain any
digital proprietary information and must provide notarized documentation to Licensor of non-
reproduction and return and/or destruction of any the PATH Module(s) under consideration. Licensor
may, at its discretion, (a) terminate any other SOWs with PURCHASER/LICENSEE as a result of such
Rejection; or (b) exercise any other remedies set forth in This Agreement or any applicable SOW.
3. Pricing and Payment.
3.1. Pricing. In full satisfaction for all Services provided by Licensor hereunder,
PURCHASER/LICENSEE agrees to compensate Licensor according to the pricing schedule
attached hereto or as otherwise set forth in the applicable SOW (Exhibit-C, “GENERAL
PRODUCTS AND PRICING SCHEDULE”).
3.2. Payment. Unless otherwise specified in the applicable SOW, Licensor shall invoice
PURCHASER/LICENSEE immediately for deposit(s), and/or complete payment of PATH Module(s)
being acquired from Licensor, with a complete, correct and audit- worthy invoice that shall, at a
minimum, provide sufficient detail to permit PURCHASER/LICENSEE to identify: (a) the specific
PATH Module(s) purchased; (b) the date(s) on which review periods begin and terminate; (c) the price
charged for each PATH Module(s); (d) any applicable taxes chargeable under Subsection 3.3; and (e)
any extraordinary charges that have been approved in advance by PURCHASER/LICENSEE. Subject to
the provisions of the SOW, PURCHASER/LICENSEE shall pay all such invoices within thirty (30) days
of receipt of the invoice (if PURCHASER/LICENSEE has established credit terms with Licensor; unless
other payment terms are expressly provided in an SOW). If PURCHASER/LICENSEE does not qualify
for credit-terms with Licensor, and/or cannot or will not provide necessary credit references to Licensor
for such qualification, payment shall be due in advance of final digital transfer of information to
PURCHASER/LICENSEE from Licensor. Under credit-terms, to facilitate prompt payment, all invoices
must be directed to, and received by PURCHASER/LICENSEE at the invoice address shown on the
applicable SOW. Any conflicts between the terms of an invoice and the terms of this Agreement shall be
resolved in favor of this Agreement. Payment hereunder shall represent full and complete compensation
for all obligations assumed by Licensor under this Agreement and for all inventions, improvements, and
copyright or patent rights assigned to PURCHASER/LICENSEE as more fully set forth in Section 10
("Ownership and Intellectual Property").
3.3. Taxes. PURCHASER/LICENSEE shall pay all sales or use taxes, Value Added Taxes, applicable Import
/ Export Duties, or other applicable taxes due on the transactions hereunder or provide Licensor
customary proof that the transactions are exempt from such taxes. Invoices shall separately identify any
tax (including Value Added Taxes as exclusively net extra) and shall include either Licensor’s sales tax
or use tax permit number. Notwithstanding, Licensor shall pay any fines, penalties or fees imposed due
to failure to file or pay collected sales or use taxes.
3.4. Expenses. PURCHASER/LICENSEE shall reimburse Licensor for any specialty security services,
transmittal documentation services and/or legal consultations that may be needed to provide digital
data transmission to PURCHASER/LICENSEE at PURCHASER/LICENSEE’S discretion.
Regulatory Governmental Entity and/or Notified Body requests for additional information, and technical support
related expenses:
In order to clarify expense types and limits and provide guidance to
PURCHASER/LICENSEE and Licensor for expense classifications,
PURCHASER/LICENSEE and Licensor agree as follows;
a. Licensor shall provide, at no charge to PURCHASER/LICENSEE, any and all support
for technical related questions that may arise during regulatory submissions regarding:
i. Data contained within any PATH Module(s) report, data record, photo-capture, or similar technical related
question. Licensor shall provide such information directly to PURCHASER/LICENSEE project contact for
use by PURCHASER/LICENSEE in communications with Regulatory Governmental Entity and/or Notified
Body.
ii. External Testing Laboratory data, report, data record, photo-capture, or similar technical related question as it
relates to the accuracy, test-method, appropriateness and sample-sizing techniques applied to any such
External Testing Laboratory information included in any PATH Module(s) acquired by
PURCHASER/LICENSEE.
b. Additional services not included in purchase price of any PATH Module(s):

i. Questions specifically related to any claims made for Safety and Efficacy, Specifications and Performance, or
other data that is exclusive proprietary information of the PURCHASER/LICENSEE contained within the
design, design-intent, specification(s), and/or labeling and literature of PURCHASER/LICENSEE’S specific
medical device as it is Intended for Use.
ii. Questions related to specific PURCHASER/LICENSEE medical-device performance, failure modes, risk-
analysis, biocompatibility, sterilization validation (unless performed by Licensor), Human Factors, Intended
Use, Contraindications, Indications for Use, or similar caveats and limitations submitted to Regulatory
Governmental Entity(ies) and/or Notified Body(ies).
PURCHASER/LICENSEE and Contractor agree that these expense exclusions and limitations
as detailed above, shall be borne by PURCHASER/LICENSEE.
c. PURCHASER/LICENSEE and Contractor further agree that consulting costs associated with
questions from a Regulatory Governmental Entity and/or Notified Body, related to Adoption
Rationale language that is independently drafted by PURCHASER/LICENSEE additional to
Adoption Rationale template language provided by Licensor, that results in questions from a
Regulatory Governmental Entity and/or Notified Body, shall be exclusively borne by
PURCHASER/LICENSEE. Consultation shall be charged at the then applicable rates by Licensor
to PURCHASER/LICENSEE, under separate SOW or Purchase Order.
3.5.Consultation Expenses, specific to Packaging Validation, Adoption Rationale Questions:

Under the specific circumstance where PURCHASER/LICENSEE has “Request for Additional
Information” (RFAI) from a Regulatory Governmental Entity and/or Notified Body Licensor
resources may be contracted by PURCHASER/LICENSEE for detailed review work of RFAI, under
separate SOW or Purchase Order, to satisfy filing response by PURCHASER/LICENSEE.
All Expenses not paid directly by PURCHASER/LICENSEE under an SOW shall be reimbursed to
Licensor within the payment terms in Section 3.2 above after receipt of Licensor’s complete, correct
and audit worthy invoice. All Expenses reimbursements shall be made at Licensor’s direct out-of-
pocket cost, plus a 15% processing fee. Invoices for Expenses should be sent to the address shown on
the applicable SOW.
4. Supply Terms.
4.1. Products and Pricing. Licensor shall make available to PURCHASER/LICENSEE those Products,
PATH Module(s), or related items, acquired by PURCHASER/LICENSEE that are described in the
General Products and Pricing Schedule attached as Exhibit A and any related SOW (both “PATH
Module(s)” and “PATH Related Digital Data”, collectively the “Products”), and shall supply
those Products via secured two-way digitally verified means such as, Lock-Lizard, DocuSign,
SignNow, HelloSign or similar secured digital transmission portal to PURCHASER/LICENSEE,
for initial review and assent for purchase. Final documents shall be unencumbered, unlocked and
otherwise fully accessible files in the Portable Document Format (PDF), with the exception of
Validated Settings Chart data, that is contained within the LICENSOR’S FDA, Master File. Final
document set shall be supplied via Digital Escrow Services, to ensure the transaction safety for both
PURCHASER/LICENSEE and LICENSOR. The Parties may add additional products to the
Products by mutual written agreement. Reference to “supply” in the context of the Products shall
mean the sale, delivery, provision and supply of Products and related terms shall have the equivalent
meaning. “General Products and Pricing Schedule” shall mean the list of Products and prices that
Licensor may charge PURCHASER/LICENSEE for such products, and as more fully described in
the Products and Pricing Schedule attached as Exhibit C.
4.2. Purchase Orders. Except as set forth herein or an applicable SOW, any and all Purchase Orders issued
by PURCHASER/LICENSEE and any and all purchase transactions between Licensor and
PURCHASER/LICENSEE shall be governed by the terms and conditions set forth in this Agreement and
the applicable SOW. The Parties agree that no other terms and conditions not referenced herein shall
apply and the Parties specifically and expressly disclaim any other or different terms and conditions,
including any other or contradictory terms and conditions contained within any Purchase Order issued by
PURCHASER/LICENSEE, any Licensor-issued documentation such as, by way of example but not
limitation, an order acknowledgement or invoice. “Purchase Order” shall mean a document (in hard
copy or electronic form) that PURCHASER/LICENSEE may, from time to time, issue to Licensor after
the Effective Date of this Agreement to specify the PATH Module(s) for purchase by
PURCHASER/LICENSEE and any sizing specifics of Products to be delivered to the
PURCHASER/LICENSEE digitally.
a. PATH Module(s): Are complete Packaging Validation Protocol and Report Sets that satisfy the
following:
.
b. Preliminary Package Test Report(s): Are confirmatory tests performed on specific PATH
Module(s), packaging materials, acquired by PURCHASER/LICENSEE, containing actual
functional (although cosmetic defects are acceptable), devices intended for patient use, that are
“Substantially Equivalent” devices, as defined per U.S., FDA, to Licensor which shall undergo
preliminary drop-testing and vibration simulation testing, per ASTM standard. The preliminary Test
Reports of such testing shall be provided to PURCHASER/LICENSEE, as further evidence of
specific packaging performance, of specific PATH Module(s), packaging materials, acquired by
PURCHASER/LICENSEE.
c. Additional Services: PURCHASER/LICENSEE may, at its discretion, extend services under either
(a) separate SOW or (b) individual Purchase Order, for services / deliverables that it deems
necessary to complete product development related efforts, for which Licensor can provide such
deliverables as mutually agreed upon in the Scope of any such SOW or Purchase Order.
5. Term and Termination.
5.1. Term. The initial term of this Agreement will commence on the Effective Date and will terminate on the same
business day as PURCHASER/LICENSEE’s, Letter of Regulatory Clearance date(“Term”), unless terminated
sooner as provided herein. Provided, however, that this Agreement shall remain in effect with respect to any
SOW then in effect at the time of such termination until performance thereunder is completed to the
satisfaction of PURCHASER/LICENSEE or as detailed in §8.5. Survival, as herein provided. The Term allows
PURCHASER/LICENSEE to make Regulatory Entity submission and determine if “Refusal to Accept” or
“Request for Additional Information” conditions manifest, and whether or not additional Licensor support is
necessary.
5.2. Termination for Breach. Either Party may terminate this Agreement or any SOW upon written notice to
the other Party in the event the other Party materially breaches this Agreement or such SOW and fails to
cure the breach within ten (10) days after receipt of written notice thereof. Material breaches by a Party
shall include, but are not limited to: (a) the filing of bankruptcy, receivership or similar proceeding due to
insolvency (voluntarily or involuntarily) with respect to such Party; (b) dissolution, liquidation or other
discontinuation of all or a significant part of the such Party’s business operations or the threat to cease to
carry on all or a significant part of its business operations; (c) with respect to Licensor, material adverse
change in Licensor’s financial condition or failure to meet any of its debt obligations when due; (d) any
unapproved assignment of Licensor’s obligations under this Agreement; I any material breach of such
Party’s representations and warranties; (f) any material non-performance of such Party’s obligations
under this Agreement or an SOW (“Termination for Breach”) shall be deemed effective as of the date
specified in the notice of termination.
a. Remedies Upon Breach. Termination of this Agreement shall not excuse any failure to perform or
breach of this Agreement by PURCHASER/LICENSEE or Licensor, and Licensor and
PURCHASER/LICENSEE shall each be entitled to all remedies under this Agreement and at law or
equity with respect to such failure or breach.
b. Transition Period. Following notice of the termination of this Agreement,
PURCHASER/LICENSEE shall have no greater that one hundred twenty (120) days (such time
period being the “Transition Period”) to cease use of the IP Rights, with exceptions as defined in
8.5., Survival. Notwithstanding anything to the contrary herein, during the Transition Period,
PURCHASER/LICENSEE may continue using the existing materials containing the IP Rights
subject to the terms and conditions of this Agreement. Following the Transition Period,
PURCHASER/LICENSEE shall immediately and permanently discontinue all use of those IP
Rights related to marketing, marketing materials, website(s), and any related external
communication(s) documents that utilize any of The IP, including, without limitation, the Marks and
further will remove all uses of Licensor Names, IP Rights, and Marks from the Primary Product and
Approved Derivative Works and any new or future Regulatory Filings; the Policies & Standards;
Licensor’s trade secrets; refrain from using any other mark, name, design, or any other designation
confusingly similar to the designation “True Validated”, or any of the other IP Rights.
c. BREACH AND REMEDIES
i. Notice and Cure Period. If Licensor in good faith determines that 3 rd Party Works prepared for or
by PURCHASER/LICENSEE, or the use of IP Rights found in any such works that were not
created by any employee, manager, executive, director, contractor, or Affiliate or Licensor and
that fail to comply with any of the Policies & Standards or any other terms and conditions of this
Agreement, Licensor shall give PURCHASER/LICENSEE written notice of such failure and
demand that PURCHASER/LICENSEE , within thirty (30) days after the giving of such notice
and demand, correct the failure or cause the failure to be corrected and submit evidence of such
correction satisfactory to Licensor.
ii. Injunctive Relief. Licensor and CCT acknowledge and agree that a breach or threatened breach
by CCT, its Controlled Affiliates, or any of their Representatives of any of the terms or
conditions contained in Section I, III, IV, V, VIII or X of this Agreement, will cause immediate
and irreparable harm and damage to the other parties, and those monetary damages will be
inadequate to compensate the other party for such breach. Accordingly, Licensor and CCT agree
that Licensor and PURCHASER/LICENSEE shall, in addition to any other remedies available to
them at law or in equity, be entitled, without posting bond or other security, to seek an injunction
from any court of competent jurisdiction enjoining and restraining any breach or threatened
breach of the terms or conditions of this Agreement by CCT, its Controlled Affiliates or
Licensor, its Affiliates; or Representatives of any party.
5.3. Consequences of Termination.
a. RETURN / DESTRUCTION OF DIGITAL INFORMATION (PROPRIETARY INFORMATION).
Upon termination of an SOW, Licensor will immediately notify PURCHASER/LICENSEE that:
i. Notarized proof of complete, unambiguous, return of digital information under evaluation has been
performed by PURCHASER/LICENSEE; and
ii. Detailed documentation of internal circulation of information has been provided to Licensor, and that
all receiving individuals have been notified and are signatories to said notarized proof of return or
destruction of digital information; and
iii. Responsible individual within PURCHASER/LICENSEE’S organization has been made aware of this
Agreement and the “Digital Information Non-Proliferation requirements” contained herein, and is
hereby bound by the terms and conditions contained within this Agreement in Section 8.3..
b. All work product, for which satisfactory payment has been received by Licensor, attributable to
the terminated SOW, including, but not limited to, programs, reports, data, flow diagrams,
materials and all work in process, in whatever state of development they may exist on the date of
termination, shall be subject to the terms of Section 3.. Notwithstanding the foregoing, unless
otherwise noticed by a Party, the termination of a SOW will not constitute a termination of any
other SOW or this Agreement.
5.4. Survival. The provisions of “Consequences of Termination”, “Representations and Warranties”,
“Independent Contractor”, “Indemnity; Insurance”, “Confidentiality”, “Ownership and Intellectual
Property”, “Accidents and Emergency Medical Aid”, “Records”, “General Terms”, and “Notice”
hereof shall survive the expiration or termination of this Agreement, with the exceptions of the
following provisions “Exceptions To Survival Of Purchaser/Licensee’s Rights”, “Limitations And
Rights Revoked”, and “Quality Control”. Additionally, survival of such other provisions that would be
reasonably expected to survive the expiration or termination of this Agreement and shall be binding on
the respective successors, assigns and Affiliates of the Parties.
6. Representations and Warranties.

6.1. Warranty of The IP. Licensor warrants that (a) all specific PATH Module(s), packaging materials,
acquired by PURCHASER/LICENSEE and the IP contained therein, shall be drafted in a professional
manner in accordance with generally accepted industry standards; (b) all deliverables related to The IP,
shall be free and clear of any lien, freedom of use, security interest or other adverse claim against title;
and (c) all deliverables related to The IP shall be free and clear from all data anomalies, outliers, and
errors. PURCHASER/LICENSEE agrees that Licensor’s Services Warranty only extends to The IP and
the deliverables to be performed under this Agreement and applicable SOW, and that work performed by
PURCHASER/LICENSEE or third parties (other than Licensor, including its employees, officers, agents,
representatives, and other Subcontractors) is not covered under Licensor’s warranties unless as otherwise
set forth herein. In the event of any such defect in Licensor supplied IP, data or related reports; (i)
Licensor shall, within ten (10) days after receipt of notice from PURCHASER/LICENSEE, cure same to
PURCHASER/LICENSEE’s reasonable satisfaction at Licensor’s sole expense, including the cost of
data production, publication and transmission to PURCHASER/LICENSEE; or (ii) exercise any other
remedies set forth in the applicable SOW.
6.2. Quality Assurance. Licensor and PURCHASER/LICENSEE have entered into this Agreement with the
following requirement for governance of Quality Assurance for any PATH Module(s), packaging
materials, acquired by PURCHASER/LICENSEE; Licensor shall:
a. Perform all PATH System related work under a routinely audited, FDA registered Quality
Management System (QMS). As such, all technical data produced thereunder shall;
b. Maintain appropriate technical disciplinary division of labor to avoid conflicts in self-review of data,
data validation, outlier analysis, deviations, anomalous results and similar related technical
assessments of relevant report information; AND
c. Ensure that should PURCHASER/LICENSEE execute an additional Quality Agreement / Supplier
Quality Agreement, and any quality requirements set forth in a SOW, are appropriately captured and
maintained fully traceable per Licensor QMS requirements.
6.3. Non-conflict; Non-Infringement. Licensor represents and warrants that its execution, delivery and
performance of this Agreement and PURCHASER/LICENSEE’s subsequent use of The IP, and any
deliverable provided hereunder, do not and will not (a) conflict with or result in a material breach of
any material agreement, judgment or court decree by which Licensor is bound or (b) infringe,
misappropriate, or violate any copyright, patent, trade secret, trademark or other intellectual property or
proprietary right of any third party and that no claim of such infringement, misappropriation, or
violation has been threatened or asserted.
6.4. Compliance with PURCHASER/LICENSEE Policies. Licensor shall promote ethical business conduct
and cooperate with PURCHASER/LICENSEE’s ethics and regulatory compliance efforts, insofar as
PATH System related work must conform to necessary regulatory mandates. Licensor further represents
and warrants that it and its employees and Subcontractors shall comply with PURCHASER/LICENSEE’s
policies for data security, transmission, and data repository and retention.
6.5. Permits and Licenses. Licensor represents and warrants that it currently has, or prior to the
commencement of performance of Services under any SOW will obtain, pay for, and maintain any and
all necessary Patent(s), Copyright(s), licenses, permits, inspections, fees, and qualifications of The IP,
required to perform the Services. In addition, Licensor shall comply with all applicable safety laws
insofar as PURCHASER/LICENSEE’s then-current safety guidelines and policies require for off-site
operations.
6.6. No Claims. Licensor represents and warrants to PURCHASER/LICENSEE that there is no action, suit,
claim, investigation or proceeding pending or, to the best of its knowledge, threatened against it that, if
adversely decided, might adversely affect Licensor’s ability to enter into this Agreement or the
performance of its obligations hereunder.
7. Independent Contractor.
7.1. Relationship of the Parties. Licensor will perform this Agreement as an independent contractor,
and this Agreement will not be construed to create between the Parties the relationship of
principal and agent, joint-venturers, co-partners, employer and employee, franchiser and
franchisee or any other similar relationship, the existence of which is expressly denied by each
Party. Licensor represents that Licensor is engaged in a similar business for other clients.
Licensor will conduct its business under its own name as an independent contractor and
acknowledges that it is expressly prohibited hereby from holding itself out as an employee,
agent, partner, or representative of PURCHASER/LICENSEE. Any person employed by
Licensor to perform hereunder will not be deemed to be an employee of
PURCHASER/LICENSEE, and Licensor and its supplier(s) or Subcontractor(s) will not be, or
represent themselves to be, officers, employees, agents, or representatives of
PURCHASER/LICENSEE and will not bind, or attempt to bind, PURCHASER/LICENSEE to
any agreement, liability, or obligation of any nature.
7.2. Right to Direct Services. PURCHASER/LICENSEE will have no right to control the manner, means,
or method by which Licensor performs the Services called for by this Agreement in generating,
producing, publishing, transmitting, documenting, retaining and or similar related activities to any
deliverable of The IP. Rather, PURCHASER/LICENSEE will be entitled only to direct Licensor with
respect to the elements of The IP, to be performed by Licensor, such as selection and purchase of
specific PATH Module(s), and the results to be derived by PURCHASER/LICENSEE.
7.3. No Right to Participate in PURCHASER/LICENSEE Plans. Because Licensor is engaged in its own
independent business, Licensor and its employees and agents and those of any Subcontractor are not
eligible for and will not participate in PURCHASER/LICENSEE’s retirement plans, insurance plans,
and any other benefits normally afforded to employees of PURCHASER/LICENSEE. Licensor will bear
all responsibility and liability for the payment of all federal, state, and local income taxes due on money
received from PURCHASER/LICENSEE under each SOW and filing all appropriate tax returns and
other forms with respect thereto. Moreover, Licensor will be solely responsible for any workers’
compensation, FICA, withholding tax, unemployment compensation, and any other federal or state
payment in connection with the Services or The IP.
8. Indemnity; Insurance.
8.1. Indemnity.
a. By PURCHASER/LICENSEE: Except to the extent Licensor owes the PURCHASER/LICENSEE
Indemnitees or a duty of indemnity under Section 9.1.1 below, PURCHASER/LICENSEE shall defend,
indemnify, and hold harmless Licensor and its Affiliates, subsidiaries, shareholders, officers, directors,
employees, agents, successors and assigns (each a “Licensor Indemnitee”) from and against any and all
Damages arising from a:
i. Regulatory Entity or Notified Body submission Refusal To Accept (RTA), unless proved to be incurred by
or assessed against any shortcomings that may arise out of, are in connection with, are resulting from, or in
any way connected with (a) Licensor’s negligence or intentional omissions in The IP or production,
publication, or transmission of The IP or Additional Deliverables, resulting in said Regulatory Entity or
Notified Body, RTA.
ii. Regulatory Entity or Notified Body submission Request for Additional Information (RAI), unless proved
to be incurred by or assessed against any shortcomings that may arise out of, are in connection with, are
resulting from, or in any way connected with (a) Licensor’s negligence or intentional omissions in The IP
or production, publication, or transmission of The IP or Additional Deliverables, resulting in said
Regulatory Entity or Notified Body, RAI.
Wherein such RTA or RAI, results in delay of launch for any of PURCHASER/LICENSEE’s products,
service offerings, inter-company contract negotiations, closures or terms of closure. Furthermore,
PURCHASER/LICENSEE shall indemnify Licensor against all costs incurred as part of any RTA or RAI that
is not directly attributable to the specific PATH Module(s) acquired and used by PURCHASER/LICENSEE as
part of any filing with a Regulatory Entity or Notified Body, for which any such RTA or RAI may arise,
inclusive of issues arising from or in connection with customized adoption language used by
PURCHASER/LICENSEE, in construction of the Adoption Rationale submitted to any such agency.
PURCHASER/LICENSEE may elect to contract Licensor for Additional Services (per § 4.2.c.), as needed to
assist PURCHASER/LICENSEE in appropriate response to any such issue arising from an RTA, or RAI of an
associated PATH system filing with a Regulatory Entity or Notified Body. Additionally,
PURCHASER/LICENSEE agrees to indemnify and hold Licensor, its Affiliates, and their Representatives
harmless from any and all damages, losses, costs, and liabilities (including, without limitation, reasonable
legal fees and the cost of enforcing this indemnity, whether prior to, during or after trial, on appeal or in
bankruptcy proceedings) that it or they may suffer or incur, that have arisen out of, resulted from or are related
to: (1) any claims, actions, or lawsuits by third parties against Licensor, its Affiliates, or any of their
Representatives involving or arising from the products and services advertised and sold by
PURCHASER/LICENSEE or its use of IP Rights including without limit in Regulatory Filings by
PURCHASER/LICENSEE.
b. By Licensor: Except to the extent, if any, otherwise expressly provided in this Agreement, Licensor assumes
no liability to PURCHASER/LICENSEE or to third parties with respect to the products and services
advertised and sold by PURCHASER/LICENSEE using the IP Rights. Licensor shall indemnify, and hold
harmless PURCHASER/LICENSEE and its Affiliates, subsidiaries, shareholders, officers, directors,
employees, agents, successors and assigns (each a “PURCHASER/LICENSEE Indemnitee”) from and
against any and all third party claims, liabilities, claims, suits, actions, losses, costs, reasonable attorneys’ fees
and expenses, judgments or damages, (“Damages”), incurred by or assessed against any of the foregoing to
the extent the same arise out of, are in connection with, are resulting from, or In any way connected with (a)
Licensor, and/or its officers, employees, agents, representatives, Subcontractors, or invitees: (i) violating any
federal or state law, regulation, statute, or ordinance applicable to the performance/use of The IP, or (b) acts,
omissions, negligence, misconduct, or dishonesty in connection with the performance hereunder, or any
breach of a representation, warranty and/or covenant, or failure to perform its obligations hereunder. Licensor
shall not have the duty to indemnify a PURCHASER/LICENSEE Indemnitee under this Section to the extent
the Damages arise from PURCHASER/LICENSEE’s decision to use The IP for, or in ways that does not
comport to substantial equivalence, as defined by U.S. FDA, to the archetypal device under which Licensor
has performed detailed, accurate validation of any PATH System packaging solution, or from the original
manufacturer’s materials, including defects or flaws in said materials.
8.2. Indemnification Process.

a. With respect to any third-party claim against a PURCHASER/LICENSEE Indemnitee for which a
PURCHASER/LICENSEE Indemnitee is entitled to indemnity under Section 8.1. above,
PURCHASER/LICENSEE shall give Licensor prompt written notice of such claim and cooperate with
Licensor at Licensor’s expense. A delay in giving such notice shall relieve Licensor of liability for such claim
only to the extent that Licensor suffers actual prejudice as a result of the delay. Licensor shall have the right to
assume the defense (at its own expense) of any such claim through counsel of its own choosing by so
notifying PURCHASER/LICENSEE within thirty (30) calendar days of receipt of such notice.
PURCHASER/LICENSEE shall have the right to participate in the defense thereof and to employ counsel, at
its own expense, separate from the counsel employed by Licensor. Licensor shall not, without the prior
written consent of PURCHASER/LICENSEE, agree to the settlement, compromise or discharge of such third-
party claim.
b. With respect to any third-party claim against an Licensor Indemnitee for which an Licensor Indemnitee is
entitled to indemnity under Section 9.1.2, Licensor shall give PURCHASER/LICENSEE written notice within
15 days, of such claim and cooperate with PURCHASER/LICENSEE at PURCHASER/LICENSEE’s expense.
A delay in giving such notice within 15 days, shall relieve PURCHASER/LICENSEE of liability for such
claim only to the extent that PURCHASER/LICENSEE suffers actual prejudice as a result of the delay.
PURCHASER/LICENSEE shall have the right to assume the defense (at its own expense) of any such claim
through counsel of its own choosing by so notifying Licensor within thirty (30) calendar days of receipt of such
notice. Licensor shall have the right to participate in the defense thereof and to employ counsel, at its own
expense, separate from the counsel employed by PURCHASER/LICENSEE. PURCHASER/LICENSEE shall
not, without the prior written consent of Licensor, agree to the settlement, compromise or discharge of such
third-party claim.
8.3. Intellectual Property. In the event any of The IP or deliverables provided under this Agreement are
alleged to constitute an infringement, misappropriation, or violation of a third party’s intellectual
property rights, Licensor shall defend, indemnify, and hold harmless PURCHASER/LICENSEE
Indemnitees from and against all Damages arising therefrom. Additionally, in such event, Licensor shall,
at its expense, use reasonable and prompt efforts: (a) to procure for PURCHASER/LICENSEE the right
to continue to use such deliverables or Services; or (b) to modify the deliverables or Services so that
they are non-infringing and of at least equivalent performance and functionality; or (c) upon adequate
showing to PURCHASER/LICENSEE that both of the foregoing options are not commercially feasible,
to provide functionally equivalent replacement deliverables or IP.
a. LICENSE GRANT TO IP RIGHTS: A. Licensor’s Grant to PURCHASER/LICENSEE. To the
extent Licensor owns or controls such rights, Licensor grants to PURCHASER/LICENSEE during
the Term of this Agreement a non-exclusive, worldwide license to use the IP Rights, including,
without limitation, the Marks and certain copyrighted works, each only in connection with the
specific PURCHASER/LICENSEE ’s allowable use in Regulatory Filings (as defined in this
Agreement), and for application to Adopted Derivative products of PURCHASER/LICENSEE.
Except as set forth in this Agreement, such license as may be granted in this Agreement may not be
assigned, pledged, encumbered or otherwise transferred by PURCHASER/LICENSEE, voluntarily
or involuntarily, by operation of law or otherwise, without Licensor’s prior written consent, which
consent may be withheld in Licensor’s sole discretion, and any attempt to do so in violation of this
Agreement will be without legal effect and void under this Agreement. To the extent that the IP
Rights licensed hereunder include any trade secrets, PURCHASER/LICENSEE shall not reveal,
distribute or otherwise disclose the trade secrets to any third party.
b. Consideration for Licenses. For the promises received and given and other good and valuable
consideration, the sufficiency of which is hereby acknowledged, Licensor grants to
PURCHASER/LICENSEE the licenses and rights to the IP Rights and data contained therein as
provided in this Section. The License shall be considered fully-paid and there shall be no royalty or
other fee due for the license granted to the PURCHASER/LICENSEE herein during the period this
Agreement is in effect.
c. PURCHASER/LICENSEE ’s Grant to Licensor. To the extent PURCHASER/LICENSEE owns
such rights, PURCHASER/LICENSEE grants to Licensor (as well as Licensor’s affiliates) a non-
exclusive, world-wide, irrevocable license to use the Regulatory Filings (as herein defined) and
Approved Derivative Works (as herein defined) and such license shall include all rights necessary
for Licensor or its affiliates to advertise, promote, sell and conduct any of its business affairs and
dealings as they relate to its relationship and this license with PURCHASER/LICENSEE provided
such use by Licensor (or its affiliates) complies with all applicable state and/or federal laws, rules or
regulations (collectively, Licensor’s “Retained Rights”).
8.4. REGULATORY FILINGS AND RETAINED RIGHTS
a. PURCHASER/LICENSEE’s Regulatory Rights and Approved Derivative Uses of The IP, for
familial product extensions / iterations, is hereby granted by Licensor insofar as such Regulatory
Uses and Derivative Uses comply with §8.3.a., of this Agreement. Licensor shall retain all such
rights, including any intellectual property rights, as may exist, exclusive of any and all rights in The
IP Rights or Marks, granted to PURCHASER/LICENSEE, and subject to Licensor’s Retained
Rights, in:
i. any documents filed by PURCHASER/LICENSEE with any state or Federal Regulatory
Agency / Entity or Notified Body as well as its annual and quarterly reports and supplements
or corrections thereto (collectively, the “Regulatory Filings”); and
ii. any advertising and promotional materials that PURCHASER/LICENSEE uses on websites
and other works created by or on behalf of PURCHASER/LICENSEE subject to this License
that contain or are derived from the IP Rights or that use the Marks wherein such works have
been approved by Licensor subject to this Agreement (collectively, the “Approved Derivative
Works”).
8.5. EXCEPTIONS TO SURVIVAL OF PURCHASER/LICENSEE’S RIGHTS. PURCHASER/LICENSEE
shall continue to own such copyrights in the Regulatory Filings and Approved Derivative Works after
termination of this Intellectual Property License subject to the continuing obligations relating to the IP
Rights including as identified in this section and §8.6. and §8.7..
a. Survival of PURCHASER/LICENSEE’S rights to The IP and familial extensions thereof, shall be
limited to those familial product extensions, for which PURCHASER/LICENSEE has provided
physical samples to Licensor and for which Licensor retains the right of refusal to extend the use of
The IP, in relation to said familial product extension, at Licensor’s sole discretion, upon review of
any such physical samples provided by PURCHASER/LICENSEE.
b. Additional exclusions to survival include, but may not be limited to:
i. Invalidation of any validation(s) related to PATH Module(s), if processes are moved outside of
Licensor; PURCHASER/LICENSEE has the right and freedom to move products, at their sole
discretion, with written 60-days prior notice to Licensor, and shall thereby invoke automatic
estoppel on use of any validation work performed by Licensor or the extension of any work
performed by Licensor to any subsequent entity other than Licensor or its subsidiaries. Licensor
shall have the right to review and in its reasonable discretion approve or reject the use, as it
applies to familial product extensions / modifications, without a minimum of preliminary testing
by Licensor, if such product extension/modification exceeds the limits, as determined by
Licensor, of The IP and PATH Module(s) previously acquired by PURCHASER/LICENSEE,
capability.
ii. PURCHASER/LICENSEE’S decision to move products outside of Licensor’s manufacturing
environment, shall automatically invoke §8., indemnity clause covering Licensor against
PURCHASER/LICENSEE’S misuse of The IP, or untested familial product extensions for which
Licensor has not provided physical sample review and approval, and any subsequent FDA action
that may arise therefrom as a consequence of implementations by PURCHASER/LICENSEE of
such production environment changes or unreviewed/untested product familial extensions.
8.6. LIMITATIONS AND RIGHTS REVOKED
a. Licensor’s Retention of Rights. Licensor retains all rights in the IP Rights not expressly granted in
the License in this Agreement. PURCHASER/LICENSEE shall not use the designation “True
Validated” as a part of its identification including, without limitation, in the name of a newly formed
corporation or other entity or the name of a new product or service without the express, prior written
consent of Licensor, which consent may be granted or denied at Licensor’s discretion.
PURCHASER/LICENSEE shall provide a thirty (30)-day written notice and request to Licensor
prior to any planned use of the IP Rights as described in this section and the failure on the part of
Licensor to respond within that thirty (30)-day period shall be presumed to operate as a rejection of
such request.
b. No Sublicensing. Licensor does not grant to PURCHASER/LICENSEE, and nothing in this
Agreement shall be construed as granting to PURCHASER/LICENSEE, the right to license,
sublicense or authorize others to use the IP Rights or the Marks other than the right for
PURCHASER/LICENSEE to authorize service providers the right to use and copy the IP Rights
solely in connection with providing services to PURCHASER/LICENSEE in connection with
PURCHASER/LICENSEE’s products and services (and in connection with Approved Derivative
Works and Regulatory Filings).
c. Licensor’s Grant of Rights to Third Parties. During the Term of this Agreement, Licensor shall
retain the sole and absolute right to grant other non-exclusive licenses for some or all of the IP
Rights, including the Marks, to other entities not affiliated with PURCHASER/LICENSEE, and
Licensor shall retain ownership of the IP Rights as defined herein.
8.7. QUALITY CONTROL
a. In General. Licensor and its Representatives (as defined herein) shall have the right to oversee the
use of the IP Rights by PURCHASER/LICENSEE.
b. Licensor’s Policies and Standards. PURCHASER/LICENSEE acknowledges that Licensor has
provided, or will make available, to PURCHASER/LICENSEE certain policies and standards
necessary for the preservation of the goodwill and reputation associated with the Marks and the
value associated with the IP Rights. Such collection of policies and standards as may be amended or
supplemented from time to time by Licensor is commonly referred to as the ‘Licensor Brand
Manual’. For the purposes of this Agreement, the relevant policies and standards as contained in the
Licensor Brand Manual, together with any subsequent policies and standards adopted or amended in
accordance with this Section are collectively referred to hereinafter as the “Policies & Standards”.
Furthermore, PURCHASER/LICENSEE acknowledges that Licensor shall have the right from time
to time in its reasonable discretion, to adopt new Policies & Standards or amend any existing
Policies & Standards, which PURCHASER/LICENSEE shall follow and adhere to in exercise of
rights in the IP Rights hereunder. Licensor shall give written notice to PURCHASER/LICENSEE of
any subsequently adopted or amended Policies & Standards. Any such newly adopted or amended
Policies & Standards shall take effect with respect to this Agreement ninety (90) days from receipt
by PURCHASER/LICENSEE.
c. PURCHASER/LICENSEE ’s Compliance with Policies & Standards. PURCHASER/LICENSEE
shall at all times during the Term of this Agreement comply with, and shall cause each of its
Controlled Affiliates as well as any agents, contractors or consultants providing promotional,
marketing, or regulatory filing services to PURCHASER/LICENSEE, at all times during the Term
of this Agreement to comply with the Policies & Standards.
d. Licensor and PURCHASER/LICENSEE acknowledge and agree that PURCHASER/LICENSEE
shall be responsible for any violation of or failure to comply with the Policies & Standards by any
employee, manager, executive, director, contractor or other agent of PURCHASER/LICENSEE,
including, but not limited to, any failure to comply with the Policies & Standards when creating or
having created any Regulatory Filings, Marketing or Promotional materials, or Approved Derivative
Works.
e. PURCHASER/LICENSEE ’s Policies. PURCHASER/LICENSEE shall have the right to adopt
additional policies and standards (“PURCHASER/LICENSEE’s Policies”) for the Approved
Derivative Works so long as same do not conflict with or contradict the Policies & Standards or
Licensor’s Retainer Rights. If any of PURCHASER/LICENSEE’s Policies conflict with or
contradict any of the Policies & Standards or Licensor’s Retained Rights,
PURCHASER/LICENSEE shall promptly discontinue use of such conflicting
PURCHASER/LICENSEE’s Policies to the extent that such PURCHASER/LICENSEE’s Policies
are in conflict with the Policies & Standards or Licensor’s Retained Rights.
8.8. Modifications to IP Rights. Except as set forth in the Policies & Standards, PURCHASER/LICENSEE
shall not make or use any modification to any of the IP Rights without the prior express written approval
of Licensor, which approval or rejection of any such modifications shall be made at Licensor’s sole
discretion.
8.9. Limitations on PURCHASER/LICENSEE’s Use. PURCHASER/LICENSEE will use the Marks and
other IP Rights, Approved Derivative Works and Regulatory Filings, solely in connection with the
promotion of PURCHASER/LICENSEE’s, OEM marketed products, in PURCHASER/LICENSEE’s
websites, advertising, promotional and other materials relating to PURCHASER/LICENSEE’s products.
Such use of the Marks and other IP Rights by PURCHASER/LICENSEE shall also be consistent with
and shall not be used beyond the scope of the license provided in this Agreement.
8.10. Provision of Samples. PURCHASER/LICENSEE will provide Licensor with representative samples of
principal initial product and any new product familial extensions that are intended for use with or
contain the IP Rights that have been prepared for, in connection with, or related to the promotion, sale,
regulatory activities or performance of PURCHASER/LICENSEE’s products and services at least thirty
(30) business days prior to any filing, distribution or use of such new materials should same have been
prepared or made by PURCHASER/LICENSEE or a third-party agent or contractor retained by
PURCHASER/LICENSEE (collectively, “3rd Party Works”).
Further, materials to be used for, in connection with or related to the promotion, sale, regulatory
activities or performance of PURCHASER/LICENSEE’s products and services prepared by an affiliate
of Licensor shall be presumed to be compliant with the Policies & Standards. For materials prepared as
Regulatory Filings, PURCHASER/LICENSEE shall, at a minimum, notify Licensor of such filing(s)
and provide detailed identification of such Regulatory Filings, without unnecessary disclosure of
Confidential Information, and Licensor shall have the right to review and in its reasonable discretion
approve or reject such use of only the IP Rights as may be contained or used in the Regulatory Filings.
Any item submitted for approval shall be reviewed and either approved or disapproved within thirty (30)
business days after submission to Licensor. Once approved, no further approval from Licensor shall be
required for extended promotions, advertising or marketing campaigns using such approved materials;
provided however, that Licensor must review and approve any Regulatory Agency required changes to
the IP Rights as used in the Regulatory Filings.
8.11. OWNERSHIP AND INFRINGEMENT
8.12. Ownership. PURCHASER/LICENSEE acknowledges and agrees that the IP Rights including, without
limitation, the Marks and the goodwill associated with the IP Rights, are owned by Licensor and are the
exclusive property of Licensor and can be used only with Licensor’s prior written consent as granted
through this License. PURCHASER/LICENSEE will retain the goodwill in its business apart from the
goodwill associated with the use of the Marks and IP Rights. PURCHASER/LICENSEE further
acknowledges and agrees that upon the termination of this Agreement all of
PURCHASER/LICENSEE’s rights in the IP Rights shall survive with certain limitations as defined in
§8.5., and PURCHASER/LICENSEE shall have no interest in or right to use any of the IP Rights,
including, but not limited to, the Policies & Standards, proprietary management systems or any trade
secrets which may have come into the possession of PURCHASER/LICENSEE through routine
interaction. PURCHASER/LICENSEE will not in any manner represent that it owns the IP Rights or
any part or component of the IP Rights, and PURCHASER/LICENSEE hereby acknowledges that its
use of the IP Rights shall not create any right, title, or interest in or to the IP Rights in favor of
PURCHASER/LICENSEE, but that all use by PURCHASER/LICENSEE of the IP Rights shall inure to
the sole benefit of and be on behalf of Licensor. Should PURCHASER/LICENSEE use any part or
component of the IP Rights or create any expansion of the Services in violation of this Agreement,
PURCHASER/LICENSEE shall execute and deliver to Licensor an assignment of all rights
PURCHASER/LICENSEE might have created in any work, trademark, or other intellectual property
right using or including the IP Rights together with any goodwill associated with the IP Rights for such
expansion of the Product(s). PURCHASER/LICENSEE further acknowledges and agrees that
PURCHASER/LICENSEE will not at any time do, or cause to be done, any act or thing to contest,
oppose, seek to invalidate or in any way impair or intend to impair the validity or enforceability of any
applications, registrations, or rights in or for the IP Rights or any of Licensor’s exclusive right, title and
interest in the IP Rights.
8.13. REGISTRATIONS; Corporate Names. PURCHASER/LICENSEE will not register or apply to register
any corporate name, trademark, copyright, design registrations or any other proprietary rights, in any
country, state or other jurisdiction utilizing any part or component of the IP Rights. For the avoidance
of doubt, PURCHASER/LICENSEE may not use the designation “True Validated” or any other IP
Rights in PURCHASER/LICENSEE ’s corporate name or as an identifier of PURCHASER/LICENSEE
or in any manner that may cause the general public to identify PURCHASER/LICENSEE with Licensor,
except to communicate, as necessary or appropriate, that PURCHASER/LICENSEE has legally
acquired license to any PATH System Module(s), per an existing SOW.
8.14. Infringement. During the Term of the License, PURCHASER/LICENSEE shall promptly notify
Licensor in writing of any suspected or actual infringement of the Marks as may come to
PURCHASER/LICENSEE’s attention. In the event of any suspected or actual infringement, Licensor
has the right, but not the duty, to take any legal action or other measures to protect the Marks against
such infringement. PURCHASER/LICENSEE shall cooperate with Licensor in any such actions or
measures at Licensor’s request and sole expense. In any action brought by Licensor: (a) Licensor shall
retain full control thereof, including the settlement or other disposition of the action; and (b) any
recovery shall be solely for the account of Licensor.
8.15. REPRESENTATIONS, WARRANTIES, AND COVENANTS
a. By Licensor. Licensor represents, warrants and covenants that Licensor is a corporation duly
organized and in good standing under the laws of the State of California; and that Licensor has full
corporate power and authority, and has taken all corporate actions necessary to enter into this
Agreement, to perform its obligations under this Agreement, and to grant the rights granted under
this Agreement, and that this Agreement constitutes a legal, valid and binding agreement of
Licensor, enforceable against Licensor in accordance with its terms.
b. By PURCHASER/LICENSEE. PURCHASER/LICENSEE represents, warrants and covenants that
PURCHASER/LICENSEE, as fully named on the accompanying signature page, is a corporation
duly organized and in good standing under the laws of its State of residency; and that
PURCHASER/LICENSEE has full corporate power and authority, and has taken all corporate
actions and has obtained all necessary approvals or authorizations from any other third party and
government authority, to enter into this Agreement, to perform its obligations under this Agreement,
and to grant the rights granted under this Agreement, and that this Agreement constitutes a legal,
valid and binding agreement of PURCHASER/LICENSEE, enforceable against
PURCHASER/LICENSEE in accordance with its terms.
8.16. CONFIDENTIALITY [HARMONIZE WITH SECTION-10]
a. Confidential Information. For purposes of this Agreement: (1) “Confidential Information” means (a)
with respect to Licensor, the Policies & Standards and confidential or proprietary information,
financial or otherwise, about the business, affairs, and assets of Licensor or its Affiliates, and
Licensor’s management strategies, whether or not any such documents, information, or materials are
marked “confidential” or “proprietary”; and (b) with respect to PURCHASER/LICENSEE,
confidential or proprietary information, financial or otherwise, about the business, affairs, and assets
of PURCHASER/LICENSEE or its Controlled Affiliates; (2) “Affiliate” means any entity other than
CCT or any of its Controlled Affiliates, that controls, is controlled by, or is under common control
with Licensor; (3) “Controlled Affiliates” means any entity that is controlled by CCT; (4) the term
“control”, including the terms “controlling”, “controlled by” and “under common control with,”
means the possession, directly or indirectly, of the power to direct or cause the direction of the
management and policies of a person, whether through the ownership of voting shares, by contract,
or otherwise; (5) “Representative” means the employees, contractors, agents, directors, officers,
legal counsel, accountants and financial advisors of a party; and (6) solely for the purposes of this
Section X, references to a party by name or by reference to “party” shall include its Controlled
Affiliates if the reference is to CCT, and their Representatives unless the context indicates otherwise.
b. Nondisclosure of Confidential Information. None of PURCHASER/LICENSEE, its Controlled
Affiliates, Licensor, its Affiliates or their Representatives shall disclose or use any Confidential
Information that is furnished, or to be furnished, to any of them by the other parties at any time or in
any manner other than as permitted by this Agreement.
c. Exceptions. Notwithstanding the prohibition in Section X(B), a party (the “Disclosing Party”) shall
be entitled to disclose Confidential Information about the other parties (the “Non-Disclosing
Parties”): (1) where CCT is the Disclosing Party, to its Controlled Affiliates and its and their
Representatives to the extent necessary to permit CCT, its Controlled Affiliates, and its and their
Representatives to produce PURCHASER/LICENSEE’s products and services and with respect to
Licensor, to its Affiliates and its and their Representatives to perform their obligations hereunder;
(2) to the extent such information becomes lawfully part of the public domain or is obtained from a
third-party other than in violation of this or any other restrictive agreement with the Disclosing
Party, its Affiliates or Controlled Affiliates (as applicable) and their Representatives; (3) as
compelled or required by a valid subpoena or other legal mandate; provided, however, in the event
that the Disclosing Party or its Representatives receive such a subpoena or other legal mandate, it
shall provide the Non-Disclosing Parties with prompt written notice of same as far in advance as
practicable of the date the Disclosing Party is required to make such disclosure so that the Non-
Disclosing Parties may seek an appropriate protective order for the Confidential Information or
waive compliance with the provisions of Section X (B); and in the absence of a protective order or
the receipt of a waiver hereunder, the Disclosing Party or any of its Representatives is nonetheless,
in the written opinion of such party’s legal counsel, so compelled to disclose the Confidential
Information, such party or its Representative may disclose only that portion of the Confidential
Information that is, based on the written advice of its legal counsel, legally required to be disclosed;
(4) as required by applicable law, rule or regulation, including without limitation, the rules of any
exchange or quotation system on which PURCHASER/LICENSEE’s, its Controlled Affiliates’,
Licensor’s, or its Affiliates’ class or series of equity is listed or quoted for trading, as applicable; (5)
as is necessary to enforce the terms of this Agreement.
d. Obligations Upon Termination. Upon a termination of this Agreement for whatever reason, each
party shall promptly return, in the manner reasonably directed by the other parties, all of the
Confidential Information that has been furnished to it or, alternatively, each party shall promptly
destroy copies of all documents or materials in its possession or control that contain Confidential
Information or portions of Confidential Information of the other parties, in whatever form or
medium such copies or portions are contained, whether tangible, electronic, or otherwise, unless
retention of same is required by Federal, state or other law, rule or regulation; and shall timely
furnish to the other parties a written certificate to the reasonable satisfaction of the other party
certifying that such destruction has taken place.
e. Non-Confidential Information. Notwithstanding the foregoing confidentiality provisions of this
Section X, at no time shall the Regulatory Filings or Approved Derivative Works materials or
deliverables created by PURCHASER/LICENSEE for the purpose of publicly advertising or
marketing the products and services of the PURCHASER/LICENSEE be considered Confidential
Information.
8.17. DISPUTE RESOLUTION; ARBITRATION
a. In the event of any dispute or claim between Licensor and PURCHASER/LICENSEE under this
Agreement or arising out of or in connection with the interpretation of or performance under the
Policies & Standards, the parties hereto agree to submit such disputes to binding arbitration before a
panel of three (3) arbitrators in accordance with the Commercial Arbitration Rules, as amended from
time to time, of the American Arbitration Association. Said panel of arbitrators shall be composed of
one (1) arbitrator selected by each party with the third arbitrator being selected by the other two (2)
arbitrators. The arbitration proceedings shall be undertaken in as expeditious a manner as possible.
The arbitration proceedings shall take place in Orlando, Florida. Judgment upon any award rendered
by the arbitrators shall be entered into any court having competent jurisdiction without any right of
appeal. Each party shall pay its own expenses of arbitration, and the expenses of the arbitrators and
the arbitration proceeding shall be shared equally. However, if in the opinion of a majority of the
arbitrators any claim or defense was unreasonable, then the arbitrators may assess, as part of their
award, all or any part of the arbitration expenses of the other party (including reasonable attorneys’
fees and costs) and of the arbitrators and the arbitration proceeding.
8.18. Insurance. Unless otherwise agreed to in writing, Licensor shall, at a minimum and at its own expense,
carry and maintain during the entire term of this Agreement, including any subsequent extensions
thereof, the following types and limits of insurance coverage (the “Required Insurance”):
a. Employer’s Liability insurance with limits of not less than $1,000,000 per accident for bodily injury
and $1,000,000 per employee and policy limit for disease (US) or the local statutory limit,
whichever is greater;
b. Professional or Errors and Omissions Liability insurance with a limit of not less than $3,000,000 per
claim and annual aggregate. Such insurance shall cover negligent acts, errors or omissions, or lack of
ordinary skill in providing Services under this Agreement.
Insurance Requirements. The Required Insurance under (a) and (b) above must (i) include
PURCHASER/LICENSEE as an additional insured, and (ii) otherwise extend Licensor’s insurance
to PURCHASER/LICENSEE with respect to losses arising out of negligence in Licensor’s
performance or provision of The IP, or related Services under this Agreement. The Required
Insurance must not be canceled or materially changed without at least thirty (30) days prior written
notice to PURCHASER/LICENSEE, under the duration of this Agreement. The Required
Insurance shall be provided by insurers with an A.M. Best rating of not less than A- / VIII or
otherwise satisfactory to PURCHASER/LICENSEE. If Licensor uses any Subcontractor in the
performance or provision of Services under this Agreement, Licensor will ensure that such
Subcontractor is covered by the Required Insurance or maintains its own insurance that meets such
requirements and will furnish PURCHASER/LICENSEE with evidence that such requirement has
been met.
9. Confidentiality / Confidential Information.
9.1. PURCHASER/LICENSEE Confidential Information. During the Term of this Agreement and
surviving its expiration or termination, Licensor will regard and preserve as trade secrets, all present and
proposed future business activities and all proprietary and confidential information related to the business
of PURCHASER/LICENSEE and its Affiliates and its or their customers, vendors, employees, and/or
agents that may be obtained from any source, whether written or oral, as well as all information on
PURCHASER/LICENSEE’s mainframe, LANs and workstations and all software, middleware, firmware,
groupware and licensed internal code and groupware whether owned or licensed currently or in the future
accessed by Licensor by any direct or remote access method and also including but not limited to any
information relating to the pricing, software or technical information, hardware, methods, processes,
financial data, lists, apparatus, statistics, program, research, development or related information of
PURCHASER/LICENSEE and its Affiliates and its or their customers, vendors, employees and/or agents
concerning past, present, or proposed future business activities of said entities, and/or the results of the
provision of Services (collectively “PURCHASER/LICENSEE Confidential Information”). Upon the
written request by PURCHASER/LICENSEE, Licensor shall deliver to PURCHASER/LICENSEE all
items, including, but not limited to, drawings, descriptions, test data or other papers or documents,
Licensor and/or its personnel have in their possession that contain any PURCHASER/LICENSEE
Confidential Information that were furnished to Licensor by PURCHASER/LICENSEE and will destroy
all notes, analyses, interpretations, memoranda and other documents, materials or reports (in any form or
medium) that were prepared by or for Licensor that contain, reflect, or are based upon, in whole or in
part, PURCHASER/LICENSEE Confidential Information that Licensor shall remain liable and be
responsible for the Licensor’s employees and Subcontractors compliance with the confidentiality
obligations set forth herein.
9.2. Confidentiality and Non-use. In addition to the requirements of Section 9.1., any information provided
in connection with the Services that is designated by Licensor (“Disclosing Party”) as confidential or
that by nature of the information disclosed, Licensor or PURCHASER/LICENSEE (“Receiving Party”)
reasonably should know such information is confidential, will be held in confidence. The Receiving Party
will use at the least the same level of care to prevent any unauthorized use or disclosure of such
confidential information as it exercises in protecting its own information of a similar nature, but in no
event less than a reasonable standard of care. The Receiving Party will not, without the prior written
consent of the Disclosing Party, make use of the confidential information disclosed to it other than for the
purpose of performance of this Agreement, or disclose the confidential information to any person, party,
or entity except to such of its officers, employees, and consultants to whom disclosure is necessary and
who have been made aware that the confidential information is confidential and are bound to treat it as
such.
9.3. Exceptions. The confidentiality and non-use obligations of this Agreement will not apply to the following
as established by reasonable proof: (a) information that at the time of disclosure is in the public domain;
(b) information that, after disclosure, becomes part of the public domain by publication or otherwise,
except through a breach of this Agreement; (c) information that the Receiving Party can establish was in
its possession prior to disclosure or was subsequently and independently developed by employees of or
on behalf of the Receiving Party without use, direct or indirect, of information required to be held
confidential hereunder information approved in writing by the Disclosing Party for release by the
Receiving Party; information that is or was received by the Receiving Party from a third party having
legal right to transmit the same, free of any obligation of confidence; or (f) the communication is in
response to a valid order by a court of competent jurisdiction or otherwise required by law, provided,
however, in the event that Receiving Party is requested pursuant to, or required by applicable law,
regulation or legal process such as interrogatory, request for information or documents, subpoena,
deposition or civil investigative demand to disclose any Confidential Information, Receiving Party shall
notify Disclosing Party so that Disclosing Party may seek an appropriate remedy or waive compliance
with the terms hereof. If the Disclosing Party waives compliance with respect to a specific request or
requirement, Recipient shall disclose only that portion of the confidential information that is covered by
such waiver and that is necessary to disclose in order to comply with such request or requirement. If, in
the absence of a waiver by the disclosing party, the Disclosing Party has not secured a protective order
or other appropriate remedy and Receiving Party is nonetheless compelled to disclose any confidential
information, the Receiving Party may, without liability hereunder, disclose only that portion of the
confidential information that is in the good faith determination of the Receiving Party after discussion
with outside counsel necessary to be disclosed.
9.4. Injunctive Relief. Receiving Party acknowledges that the unauthorized use or disclosure of
confidential information of the Disclosing Party may give rise to irreparable injury to the
Disclosing Party and that injury may not be adequately compensated by damages, and that
accordingly, the Disclosing Party may seek and obtain injunctive relief against the Receiving Party
to prevent the breach or threatened breach of any promise made in this Agreement in addition to
any other legal remedies that may be available to the Disclosing Party.
10. No Conflicts. Licensor represents that it is not now under any obligation to assign inventions or other
Intellectual Property Rights, which obligation would conflict with those contained in this Agreement and
Licensor agrees not to enter into any such conflicting agreements or arrangements during the Term of this
Agreement.
11. Security. Licensor shall work with PURCHASER/LICENSEE to coordinate all security activities relating to
providing its personnel with access to PURCHASER/LICENSEE’s information systems through the
designated security contact at the applicable PURCHASER/LICENSEE location. It is the responsibility of
Licensor to notify PURCHASER/LICENSEE when any of its personnel who have been granted access to
PURCHASER/LICENSEE facilities, Confidential Information or other systems no longer need access to
PURCHASER/LICENSEE facilities, servers, FTP locations etc., for access to such Confidential Information
or other systems within five (5) days of such a change.
12. Records and Inspections/Audits.
12.1. Records. Licensor shall keep complete and systematic written records of all Services provided to
PURCHASER/LICENSEE. Such records shall include records relevant to any Expenses incurred by
Licensor on behalf of PURCHASER/LICENSEE and any financial records, procedures (including
records for compliance with federal, state and local law) and such other documentation pertaining to
Licensor’s performance under this Agreement, and Licensor shall preserve all such records until seven
(7) years after the termination or expiration of this Agreement. During the Term of this Agreement
and for seven (7) years thereafter, PURCHASER/LICENSEE shall have the right to inspect, copy and
audit such records during Licensors regular working hours. Licensor shall fully cooperate in any such
inspection or audit of its records.
(ii) Request for Inspection/Audit & Security Compliance. Upon five (5) business days’ notice to
Licensor and during normal business hours, PURCHASER/LICENSEE shall be permitted to audit,
inspect, and/or verify relevant Licensor’s operations and other areas of Services to confirm that (i)
Licensor is maintaining controls and security measures specific to Licensor’s fulfillment of its
obligations to PURCHASER/LICENSEE pursuant to this Agreement billings to
PURCHASER/LICENSEE are correct, and (iii) reports relating to Licensor’s performance are
complete and accurate (collectively, “Inspection(s)”).
12.2. Nature of Inspection. PURCHASER/LICENSEE shall clearly state the nature of the Inspection. Such
Inspections shall be limited to information that relates directly to Licensor’s fulfillment of its
obligations pursuant to this Agreement. PURCHASER/LICENSEE, at its expense, may conduct
Inspections itself or with the assistance of a third-party organization, provided that the third-party
organization executes confidentiality agreement reasonably acceptable to Licensor. All Inspections
will be performed in a manner and frequency intended to minimize disruption to Licensor’s business.
12.3. Access. Licensor will provide to PURCHASER/LICENSEE and its auditors (including internal audit
staff), inspectors, regulators, consultants and other representatives (collectively “Inspectors”) as
PURCHASER/LICENSEE may from time to time designate in writing, reasonable access to: (i)
Licensor’s facilities (and Subcontractor facilities to extent applicable) where the Services are being
performed; (ii) Licensor’s personnel and Subcontractors performing any Services hereunder; (iii)
documents, data, and records related to the performance of Licensor’s obligations hereunder; in the
possession of Licensor relating to any of its operations related to the Services. Licensor will provide
such access to Inspectors upon reasonable written notice by PURCHASER/LICENSEE during regular
business hours, provided that all such persons adhere to Licensor’s security and safety policies and have
executed a confidentiality agreement reasonably acceptable to Licensor. Upon reasonable request by
PURCHASER/LICENSEE, Licensor will assist and cooperate with the Inspectors in connection with
Inspection functions, including the review and/or timely remediation of audit issues.
12.4. Data Protection. Licensor shall maintain necessary digital protections on data-vault repositories such
that PURCHASER/LICENSEE digital information provided pursuant to this Agreement shall be
maintained within “fire-walled” protected servers. Data transmissions to and from
PURCHASER/LICENSEE Affiliates and third parties shall be performed with password protected
account access to shared file locations prohibiting untoward information loss, theft, or corruption.
13. Compliance with Laws
13.1. No Discrimination. Licensor and its Subcontractors shall abide by the requirements of 41 CFR 60-
300.5(a), as applicable. 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.
13.2. Licensor and its Subcontractors shall abide by the requirements of 41 CFR 60-741.5(a), as applicable.
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.
13.3. Fair Labor Standards Act. The requirements of sections 6, 7, and 12 of the Fair Labor
Standards Act, as amended, and all regulations and orders issued under section 14 thereof.
13.4. U.S. Immigration Laws. Licensor represents and warrants that to the extent applicable to its
performance under this Agreement and as required by the United States’ immigration or acquisition
laws, including but not limited to the requirements set out at 48 C.F.R. 52.222-54 (the Federal ‘E-
Verify’ program), Licensor and its employees and Subcontractors are entitled to work in the United
States and, upon request, Licensor shall provide to PURCHASER/LICENSEE documented proof of
eligibility to work in the United States for itself and its employees and Subcontractors.
13.5. Warranty of Non-Exclusion. Licensor represents and warrants that Licensor and Licensor’s directors,
officers, employees and agents: (i) have not been and are not currently excluded pursuant to 42 U.S.C.
§1320a-7 or similar state exclusion authority, debarred, or otherwise ineligible to participate in any
Federal health care program as that term is defined in 42 U.S.C. §1320a- 7b(f) or comparable state
programs; (ii) have not been convicted of a criminal offense related to the provision of health care
items or services or any other offense that may lead to exclusion under 42 U.S.C. §1320a-7 or similar
state exclusion authority. Licensor shall have an ongoing obligation to ensure the accuracy of the
foregoing representations and warranties. If any change in circumstance occurs to make any foregoing
representation or warranty inaccurate, then Licensor shall notify PURCHASER/LICENSEE in writing
immediately.
14. General Terms.
14.1. Governing Law, Jurisdiction. The Parties agree that laws of the State of California shall govern the
validity and construction of this Agreement and any dispute arising out of or relating to this Agreement,
without regard to the principles of conflict of laws.
14.2. Agreement to Arbitration. The Parties hereby agree in advance, that any controversy or claim arising
out of or relating to this MSA, or the breach thereof, shall be settled by arbitration administered by the
American Arbitration Association in accordance with its Commercial [or other] Arbitration Rules per
the State of California, and judgment on the award rendered by the arbitrator(s) may be entered in any
court having jurisdiction thereof.
14.3. Severability. A ruling by any court that one or more of the provisions contained in this Agreement is
invalid, illegal, or unenforceable in any respect shall not affect any other provision of this Agreement so
long as the economic or legal substance of the transactions contemplated hereby is not affected in any
manner materially adverse to any Party. Thereafter, this Agreement shall be construed as if the invalid,
illegal, or unenforceable provision had been amended so as to make this Agreement valid and
enforceable as originally contemplated by this Agreement to the greatest extent possible.
14.4. Counterparts. This Agreement may be executed in counterparts, each of which shall be deemed an
original but all of which together shall be considered one and the same agreement and shall become
effective when counterparts have been signed by each of the Parties hereto and delivered to the other
Party. The exchange of copies of this Agreement or any amendments hereto and of signature pages by
facsimile transmission or by email transmission in portable document format, or similar format, shall
constitute effective execution and delivery of such instrument(s) by the Parties, and may be used in lieu
of the original Agreement for all purposes. Signatures of the Parties transmitted by facsimile or by
email transmission in portable document format, or similar format, shall be deemed to be their original
signatures for all purposes.
14.5. Headings. The section headings contained in this Agreement are inserted for convenience of reference
only and shall not otherwise affect the meaning or interpretation or be deemed to be a substantive part
of this Agreement, except where used in the body of this Agreement to reference substantive
obligations.
14.6. Binding Effect. This Agreement shall be binding upon and shall inure to the benefit of the Parties and
their respective legal representatives, successors and permitted assigns. Except as otherwise
specifically provided, this Agreement is not intended and shall not be construed to confer upon or to
give any person, other than the Parties hereto, any rights or remedies.
14.7. Entire Agreement. This Agreement, including any documents referred to herein and any exhibits
attached hereto and any executed SOW, constitutes the entire agreement between the Parties, and there
are no other representations, warranties, covenants or obligations. The signing by both Parties shall
cause this Agreement to be valid on the Effective Date. This Agreement supersedes all prior and
contemporaneous agreements, understandings, negotiations and discussions, written or oral, of the
Parties, relating to any transaction contemplated by this Agreement (including any confidentiality
agreement(s) entered into by the Parties or their Affiliates for the purposes of effectuating this
Agreement). No course of dealing or usage of trade shall be used to modify the terms hereof. The
documents referred to herein and attached hereto shall be read together with this Agreement to determine
the Parties’ intent. In the event of a conflict between or among such documents, the documents shall
govern in this order: (1) this Agreement, and (2) an SOW (3) a Purchase Order (except no terms or
conditions in any Purchase Order shall have any force or effect).
14.8. Waiver; Modification of Agreement. Waiver of any breach under this Agreement shall not constitute
waiver of any other breach of the same or any other provision. Acceptance of any items or payment
therefor shall not waive any breach. No provision hereof or right hereunder may be waived except in
a writing executed by an authorized representative of the Party to be charged, which writing
expressly waives an identified portion of this Agreement. No modification of any of the terms of this
Agreement shall be valid unless in writing and signed by authorized representatives of both Parties.
14.9. Rights and Remedies Non-Exclusive. No right or remedy conferred in this Agreement is intended to be
exclusive of any other right or remedy, and each and every right and remedy shall be cumulative and in
addition to any other right or remedy given now or existing in law or in equity or by statute.
14.10. Assignment. Except as otherwise set forth herein, neither Party shall transfer or assign any or all of
its rights or interests under this Agreement or delegate any of its obligations without the prior written
consent of the other Party. No assignment shall relieve either Party of the performance of any accrued
obligation that such Party may then have under this Agreement. Any attempted assignment of this
Agreement not in compliance with this paragraph shall be of no force or effect. Notwithstanding the
above, PURCHASER/LICENSEE shall have the right to assign or otherwise transfer its interest under
this Agreement to (i) an affiliate, (ii) in connection with a merger, consolidation, or other business
combination, or (iii) in connection with the disposition of all or substantially all the assets of
PURCHASER/LICENSEE.
15. Notice.
15.1. All notices, requests, demands and other communications to be given under this Agreement shall be
in writing and shall be deemed to have been duly given if delivered by hand, sent by facsimile or
other means of electronic communication with confirmation, sent by a nationally recognized
overnight delivery service, or certified mail return receipt requested, to:
To: To: Eagle Medical Packaging Sterilization, Inc.
Address: Address: 2921 Union Rd # A,

Paso Robles, CA 93446
Facsimile: Facsimile: 1 (805) 238 6541

Attention: Attention: Doyle Timmons
with copy to: with copy to: Roy Morgan
Notices shall be effective upon receipt. A Party may change its address listed above by notice to the other
Party.
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed by their
duly authorized corporate officers or representatives as of the date first above written.
PURCHASER/LICENSEE Licensor
Eagle Medical Packaging, Sterilization, Inc.
[Printed Name]
By:
By:
Name (printed): Name: Doyle L. Timmons
Title: Title: President & CEO
Attachments:
Exhibit A Sample – Additional Services – Statement of Work
Exhibit B Sample Opt-Out Agreement Form, Custom Design in Lieu of PATH System
Exhibit C PATH System, Products and Pricing Schedule
EXHIBIT A
SAMPLE --- ADDITIONAL SERVICE REQUEST(S)
STATEMENT OF WORK
This Additional Service Request-Statement of Work (hereinafter referred to as the “SOW No. ”) is
executed and entered into and made effective as of (“Effective Date”) by
and between (“Licensor”) with offices located at and
(“PURCHASER/LICENSEE”) with offices located at .
WHEREAS, PURCHASER/LICENSEE and Licensor have entered into a Master Services & IP Agreement,
Contract # with an Effective Date of
(hereinafter referred to as the “Agreement”); and
WHEREAS, pursuant to the Agreement, Licensor will provide and perform the additional services
described in this SOW for PURCHASER/LICENSEE; and
NOW, THEREFORE, in consideration of the foregoing and the promises, covenants, and agreements
hereinafter set forth, and in further consideration of certain other valuable consideration, the receipt and
sufficiency of which each of the parties expressly acknowledges, the parties hereby agree by and between
themselves as follows:
The terms of the Agreement are hereby incorporated into, and an integral part of, this SOW.
Scope of Services. Licensor shall perform the following services for PURCHASER/LICENSEE:
Payment. Payment to Licensor for performance of the Services described in this SOW shall be as
follows: By DELIVERABLES (please specify)
Additional PATH-System Module(s) Amt. Due by Deliverable Notes
Additional Service(s) Deliverable Due Date Notes

Deliverable Description
Sterilization Validation
Biocompatibility Studies
Leachables / Extractables Studies
Cleaning / Disinfection Protocol Development
Rationale Engineering Support
Or by a RATE
Hourly:
Weekly:
Monthly:
Invoices. All invoices shall be addressed to: .
Commencement and Completion of Services. The Services described above shall commence on or
before and shall be completed on or before .
Location of Performance. The Services described above shall be performed
at________.
Expenses shall be sent to . All expense reports shall be approved by
. Please see the attached PURCHASER/LICENSEE’s Expense Reimbursement Guidelines.
Project Manager. Licensor’s manager for performance of the Services is:
Name:
Title:
Address:
Tel. No.:
Fax. No.:
Email Address:
PURCHASER/LICENSEE Designated Representative. The PURCHASER/LICENSEE representative

for the specification, approval and acceptance of the Services is:
Name:
Title:
Address:
Tel. No.:
Fax. No.:
Email Address:
Accepted and agreed:

PURCHASER/LICENSEE: Licensor Medical Packaging, Sterilization, Inc.
By:
Its:
SAMPLE – DO NOT SIGN
SAMPLE – DO NOT SIGN
By: By:
Name: Name: Doyle L. Timmons______________
Title: Title: President & CEO________________

EXHIBIT B
SAMPLE: OPT-OUT AGREEMENT FORM,

CUSTOM DESIGN IN LIEU OF PATH SYSTEM
1. All recissions from PATH Module process shall conform to the following structure and form,
unless otherwise agreed in writing.
2. Existing PATH-Module Customer (PURCHASER/LICENSEE), agrees acknowledges and

understands that if the choice to opt out of the PATH-Module Program is made, that certain
non-recoverable expenses (NRE) have been made by The Licensor, to assemble, test, validate,
report, and format deliverables for PURCHASER/LICENSEE. PURCHASER/LICENSEE,
further acknowledges that, should they have received any portion of a PATH-System Module,
that its contents are proprietary, confidential, and subject to all the restrictions, limitations,
covenants and ownership clauses as stated in The Agreement that PURCHASER/LICENSEE
has previously signed.
3. PURCHASER/LICENSEE, hereby elects of its own volition, without duress, and without any
untoward or nefarious purpose to cease all activities in the acquisition of the PATH-System
module(s) as offered by Licensor and so disclosed in Table-1, below:
Table-1, Tabulation of PATH-System Module(s) Purchased, and/or additions to the services.
Description of Specific Listing of specific Named Responsible Confirmation of

Module Purchased Module Materials Individual by Module Materials
Received PURCHASER/ Returned to
LICENSEE Licensor, by
Licensor
PURCHASER/LICENSEE, agrees, acknowledges and understands that the following NRE costs associated with
each PATH-System module for which an Opt-Out is selected shall be charged to PURCHASER/LICENSEE as
part of release from the Agreement by Licensor, along with this signed Opt-Out Form by the responsible
individual from PURCHASER/LICENSEE. Further, any inability, unwillingness or other preclusion of
PURCHASER/LICENSEE, from obtaining signed verification by a responsible individual, shall invoke
“Unverified Pricing” schedule as tabulated in Table-2 below, which shall be borne by
PURCHASER/LICENSEE.
Table-2, NRE-Tabulation of PATH-System Module(s) Charges for Cancellation / Opt-Out.
Description of Specific Verified Signed Opt- Unverified / no Confirmation of

Module Purchased out Form for Returned signature on Opt-out signed form, by
PATH Components, Form for Returned Licensor:
NRE Cost ($ U.S.) PATH Components, Name, Init. & Date
NRE Cost ($ U.S.)
$15,000.00 $25,000.00
4. I,_____________________, The assigned responsible individual, on behalf of:______________________, do
hereby affirm, attest, and certify, that ______________________ (PURCHASER/LICENSEE), elects to cease all
activities relating to acquisition of Licensor’s PATH-System Module(s), and further has ensured that NO
COPIES, PHYSICAL, DIGITAL, PHOTOGRAPHIC, LITHO-REPRODUCTION OR OTHER TYPES, exist or
have been made by PURCHASER/LICENSEE.
By signing below, each party hereby certifies under penalty of perjury, to the provisions of this Opt-Out agreement.
PURCHASER/LICENSEE: Licensor: Eagle Medical Packaging Sterilization, Inc.
By:
Its:
SAMPLE – DO NOT SIGN SAMPLE – DO NOT SIGN

By: By:
Name: Name: Doyle L. Timmons
Title: Title: President & CEO

EXHIBIT C
GENERAL PRODUCTS AND PRICING SCHEDULE
1. PATH-System Module(s)
No Cooling Off Period. PURCHASER/LICENSEE understands, agrees, and acknowledges

that, given the nature of The IP transferred, and that such IP is transferred ‘in-toto’ to the
PURCHASER/LICENSEE, in an unencrypted, copyable format, that full and up-front payment
is required to complete any / all purchases of PATH-System module(s). Furthermore,
PURCHASER/LICENSEE, also understands, agrees, and acknowledges that, given the lack of
protections built into The IP, as intended, for PURCHASER/LICENSEE’s use as needed in its
Design History File (DHF) and necessary Regulatory Filings with government entities and/or
notified bodies, full refunds are not allowed. Minimum non-refundable deposits are required and
shall be honored by PURCHASER/LICENSEE.
2. Individual Module(s) Pricing. Table below contains the nominal pricing for each module
specific to the packaging solution type and degree of protection.
Barrier Degree of Protection

Module Description (size) / Type Price $ U.S. (single / double)
Small: $115,000.00 Not Yet Avail. Single
(3in x 7in) / Poly-Poly, Vac. Sealed
Pouch
Small: $175,000.00 Double
(3in x 7in) inside a (4in x 9in) /
Poly-Poly, Vac. Sealed Pouch
Medium: $115,000.00 Not Yet Avail. Single
(5in x 9in) / Poly-Poly, Vac. Sealed
Pouch
Medium: $175,000.00 Double
(5in x 9in) inside a (6in x 11in) /
Poly-Poly, Vac. Sealed Pouch
Large: $125,000.00 Not Yet Avail. Single
(2.5in x 19in) / Poly-Poly, Vac.
Sealed Pouch
Large: $195,000.00 Not Yet Avail. Double
(2.5in x 19in) inside a (3.5in x
23in) / Poly-Poly, Vac. Sealed
Pouch
3. Optional Additional Qualification Services.

a. PURCHASER/LICENSEE may, at its discretion, add the following additional
services, at the additional cost described below for added services to complement
PATH-System Module(s) purchased:
i. Actual Finished Device Rationale Assistance (up to 80-hours of Sr. Des. Engineering
support), as a submission aide (“DRA”) - $20,000.00
ii. Actual Finished Device Sterilization Validation (“DSV”, via irradiation)- $20,000.00
iii. Actual Finished Device Real-Time Aging (“DRTA”) - $5k - $10k, By Time Period.
4. Financial Structure and Pricing
a. Payment and Down-payment and Non-Refundable Payments.
i. PURCHASER/LICENSEE shall make a down payment of: $50,000.00, per
PATH-System Module purchased, as priced above. Each down payment shall
have a non-refundable portion, as described in Exhibit-B, Opt-Out, that shall be
lost should PURCHASER/LICENSEE, elect to terminate purchases with
Licensor. Non-refundable portions of down payments are accretive and
dependent on the total number of PATH-System Module(s) purchased by
PURCHASER/LICENSEE.
ii. If PURCHASER/LICENSEE elects to transfer into a traditional packaging
design-support and validation effort, up to 50% of each non-refundable
portion of total down-payments may be credited by Licensor toward the
Final Invoice for such efforts with Licensor.
iii. Examination period of ‘Sample Deliverables’, PURCHASER/LICENSEE
shall have a period of 10-business days, within which to perform
examination of Sample Deliverables to provide assurance that Quality of
Work, Detail Orientation, and Completeness of work are sufficient for
PURCHASER/LICENSEE to consummate the purchase of any PATH-
System Module(s). PURCHASER/LICENSEE, is hereby made aware,
that once any of The IP, including, but not limited to, Sample
Deliverables, has been supplied to PURCHASER/LICENSEE, that
non-refundable portions of payment are triggered into effect and shall
be enforced by Licensor.
b. Summary of Financial Structure and Completion Payments. The detailing pricing

and payments for The IP being licensed by PURCHASER/LICENSEE, from Licensor
under this Exhibit and the other Services described in this Exhibit are shall be paid In-
Full, prior to the delivery of the complete design validation package. In the event of any
ambiguity, conflict or inconsistency between the description of The IP, the pricing,
payment structure, and/or terms in this Exhibit, then the Services, pricing, payment
structure, and/or terms that is/are more favorable to PURCHASER/LICENSEE in this
Exhibit shall apply.

Eagle Medical Packaging - PATH-MSA-IP - 5-Jan-2022, Rev01

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Eagle Medical Packaging - PATH-MSA-IP - 5-Jan-2022, Rev01

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Master Services & IP Agreement Contract #EM2022-YYY

MASTER SERVICES & INTELLECTUAL PROPERTY AGREEMENT

2. Acceptance and Rejection of Services.

PURCHASER/LICENSEE shall be required to supply a minimum of 12 functional (although cosmetic

b. Additional services not included in purchase price of any PATH Module(s):

3.5.Consultation Expenses, specific to Packaging Validation, Adoption Rationale Questions:

6. Representations and Warranties.

8.2. Indemnification Process.

To: To: Eagle Medical Packaging Sterilization, Inc.

Address: Address: 2921 Union Rd # A,

Facsimile: Facsimile: 1 (805) 238 6541

with copy to: with copy to: Roy Morgan

Additional Service(s) Deliverable Due Date Notes

PURCHASER/LICENSEE Designated Representative. The PURCHASER/LICENSEE representative

Accepted and agreed:

Name: Name: Doyle L. Timmons______________

Title: Title: President & CEO________________

SAMPLE: OPT-OUT AGREEMENT FORM,

2. Existing PATH-Module Customer (PURCHASER/LICENSEE), agrees acknowledges and

Table-1, Tabulation of PATH-System Module(s) Purchased, and/or additions to the services.

Description of Specific Listing of specific Named Responsible Confirmation of

Table-2, NRE-Tabulation of PATH-System Module(s) Charges for Cancellation / Opt-Out.

Description of Specific Verified Signed Opt- Unverified / no Confirmation of

SAMPLE – DO NOT SIGN SAMPLE – DO NOT SIGN

Name: Name: Doyle L. Timmons

Title: Title: President & CEO

No Cooling Off Period. PURCHASER/LICENSEE understands, agrees, and acknowledges

Barrier Degree of Protection

3. Optional Additional Qualification Services.

b. Summary of Financial Structure and Completion Payments. The detailing pricing

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