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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange
Act of 1934
Date of Report (Date of earliest event reported) September 26, 2023
GlobeStar
Therapeutics Corporation
(Exact name of registrant as specified in its charter)
Wyoming
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333-170315
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27-3480481
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(State or other jurisdiction of incorporation)
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(Commission File Number) |
(IRS Employer Identification No.) |
719 Jadwin Avenue
Richland,
WA 99352
(Address of principal executive offices)(Zip Code)
509.531.1671
(Registrant’s telephone number, including area code)
www.globestarttherapeutics.com
Check the appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following provisions:
☐ |
Written communications pursuant to Rule 425 under the Securities Act (17
CFR 230.425) |
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☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12) |
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☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange
Act (17 CFR 240.14d-2(b)) |
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☐ |
Pre-commencement communications pursuant to Rule 13e-4 (c) under the Exchange
Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
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Trading Symbol(s)
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Name of each exchange on
which registered |
Common
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GSTC
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N/A |
Indicate by check mark whether the registrant is an emerging growth company as defined
in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2
of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected
not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section
13(a) of the Exchange Act.
Item 8.01 Other Events.
GlobeStar Therapeutics Corporation (the “Company” or “Globestar”)
(OTC PINK:GSTC), a clinical-stage pharmaceutical company focused on advancing new therapies for Multiple Sclerosis (MS) and other neurological
diseases has entered into a definitive agreement with Advanced Innovative Partners (AIP) for AIP to provide advice to GlobeStar and SMI
HealthCare LLC (“SMIHC”) on the global design, strategy and execution of clinical trials, regulatory filings, intellectual
property rights filings, and manufacturing for Project Amethyst™. Project Amethyst™ is a compound intended to treat neurodegeneration
from multiple sclerosis (MS). GSTC is the exclusive worldwide licensee for Project Amethyst™, including all patents and patent applications
relating thereto.
The GlobeStar and AIP agreement has been approved by the parties' respective
boards and is immediately effective. AIP will initially advise GlobeStar and SMIHC on the design and launch of an initial clinical trial
in India and the associated regulatory approvals for GSTC's MS products in North America and Europe. A memorandum of understanding previously
had been entered into by Globestar and AIP to design and implement clinical trials for Project Amethyst™, subject to the execution
of definitive agreement. Pursuant to the parties' agreement, GlobeStar retains ownership of all intellectual property rights, and final
approval of Project Amethyst™, including the right to engage additional advisors and subject matter experts. For its consulting
services, AIP will be paid a monthly consulting fee and bonuses, a portion of which will be deferred and will become payable only if GlobeStar
secures FDA marketing approval. If AIP introduces GlobeStar or SMIHC to potential customers, or strategic partners, subject to compliance
with applicable law, AIP may also become entitled to receive commissions on certain revenues or profits derived from those relationships.
The agreement with AIP builds on the recent agreement of Globestar with
SMI HealthCare LLC (SMIHC) to manage an initial clinical trial, regulatory filings, intellectual property rights filings, manufacturing,
sales and distribution in India, Southeast Asia, Africa, and the Middle East. In September 2023, Globestar entered into an agreement with
SMIHC to manage an initial clinical trial, regulatory filings, intellectual property rights filings, manufacturing, sales and distribution
in India, Southeast Asia, Africa, and the Middle East, excluding Israel and Iraq, and for government and private aid organizations, for
GlobeStar's patented Multiple Sclerosis treatment. The agreement with SMIHC was approved by the parties’ respective boards of directors.
Implementation of the first phase is subject to Globestar arranging financing. The first phase includes formation of Globestar and SMIHC
subsidiaries in India, the clinical trial, regulatory and intellectual property rights filings in India, identifying manufacturers, and
planning for the commercial launch in India and countries in the region that accept DCGI approvals. Implementation of the second phase
is expected to commence approximately nine months later, and is subject to receipt of DCGI marketing approval and GlobeStar arranging
financing. The second phase may continue for the duration of patent validity, and consists initially of sales, marketing and distribution
in India and thereafter, countries in SMIHC’s territory that will permit sales and distribution based upon DCGI approval. After
proof of market in those countries, the intention is to seek regulatory approvals elsewhere in SMIHC’s territory in order to expand
the sales and distribution of GTC’s MS products.
SMIHC is an affiliate of SMI Group LLC, a privately-held Los Angeles-based
company. The chairman of SMI Group is a Globestar shareholder and consultant, though he did not advise GlobeStar on this transaction and
has waived fees payable to an SMI company for introducing SMIHC to Globestar. In India, SMIHC is led by Mr. Tirumalai, who has more than
25 years of experience as an executive and advisor to health care providers, investors and aid organizations worldwide.
According to the U.S. National Institutes of Health, between 2013 and 2020,
the reported incidence of MS has increased by 50% in the 81 most affected countries. Although the market potential is uncertain in many
of the developing countries in SMIHC’s territory, in 2020, reported cases of MS in India reached 256,000, and total reported cases
in SMIHC’s territory exceeded 600,000. According to multiple sources, the reported incidence of MS in the Middle East and Africa
is rapidly growing, with treatments in the Middle East (excluding Israel) alone expected to grow from approximately $3.5 billion in 2023
to $4.5 billion in 2032. Within five years after launching sales in each country in which Globestar obtains regulatory approval, GlobeStar’s
goal is to capture from 20% to 50% of the market for MS therapeutics in that country.
- 2 -
The agreements with AIP and with SMIHC are attached hereto as exhibits.
The foregoing summaries do not purport to describe all material terms of each such agreement.
This report contains forward-looking information within the meaning of
Section 27A of the Securities Act of 1933 and Section 21E of the of the Securities Exchange Act of 1934, including statements that include
the words believe, expects, anticipates, or similar expressions. Such forward-looking statements involve known and unknown risks, and
other factors that may cause the actual results, performance, or achievements of the Company to differ materially from those expressed
or implied by such forward-looking statements.
The information in this Current Report on Form 8-K with respect to Item
8.01 (including the agreements attached hereto as Exhibits 99.1 and 99.2) is being furnished pursuant to Item 8.01 of Form 8-K and shall
not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (“Exchange
Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any filing
under the Securities Act of 1933, as amended, or the Exchange Act. This current report on Form 8-K (including Exhibits 99.1 and 99.2)
will not be deemed an admission as to the materiality of any information contained herein.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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GlobeStar Therapeutics Corporation |
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Date: November 13, 2023 |
By: /s/ James C. Katzaroff |
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Name: James C. Katzaroff
Title: Chief Executive Officer |
- 3 -
Exhibit 99.1
Consulting Agreement
This Consulting Agreement (“Agreement”)
dated November 2, 2023, is entered into by and between GlobeStar Therapeutics Corporation, a Wyoming corporation (“GlobeStar”)
and Advanced Innovative Partners, Inc., a Wyoming corporation (“AIP”). Each of GlobeStar and AIP is sometimes referred
to herein as a “Party” and collectively as the “Parties.”
Now, Therefore, the Parties
hereby agree as follows:
1. Certain
Definitions:
“Change Order”
means any amendment or addendum to a Work Order executed by the Parties.
“Clinical Trial”
means an interventional clinical study of the efficacy and risks of one or more GTC Products undertaken in the Territory with the goal
of assessing its effects on human health in accordance with the New Drugs and Clinical Trial Rules of 2019. There may be more than one
Clinical Trial. The term “Clinical Trial” does not include the regulatory filings or Intellectual Property Rights filings
required to permit a Clinical Trial to occur, or that may utilize results of the Clinical Trial to obtain approvals to manufacture, license,
sell or distribute GTC Products.
“Data” means
any and all information Processed by a Party under this Agreement that relates to personal information of an identifiable individual,
such as first and last name, tax number, other government-issued identifiers, date of birth, e-mail address, IP address, credit card number,
financial account number, and health information or medical records.
“GTC-IP” means
all Intellectual Property Rights owned by, licensed to, or developed by GTC, or contributed thereto by AIP pursuant to this Agreement,
including all patents licensed to, assigned to, or applied for by GlobeStar and its subsidiaries.
“GTC Product”
means a product or service manufactured by or for GlobeStar and made available under this Agreement for distribution or sale by AIP in
the Territory and to the NGO Group, consisting of Licensed Products, Licensed Methods and potentially also other GlobeStar products or
services. The initial GTC Products are set forth in Appendix A.
“Initial Clinical Trial”
means a Clinical Trial in India pursuant organized by SMIHC intended to satisfy the requirements for all approvals necessary to manufacture,
license, sell and distribute the GTC Products included in that trial in India, and potentially other countries in the Territory. By U.S.
standards, this trial would generally include FDA Clinical Trial Phases 1 and 2, and possibly certain elements of FDA Clinical Trial Phase
3, and is unlikely to satisfy all FDA requirements for Clinical Trials for marketing authorization.
“Intellectual Property
Rights” means intellectual property rights recognized in any country or jurisdiction in the world, including, without limitation,
(i) patents, patent applications, patent disclosures, and rights of priority; (ii) trademarks, service marks, trade dress, trade names,
Internet domain names, slogans, logos, and corporate names, together with all the goodwill associated therewith, and registrations and
applications pertaining thereto; (iii) copyrights (registered or unregistered), moral rights, and copyrightable works and registrations
and applications for the registration thereof; (iv) computer software, data, databases, and documentation thereof; (v) trade secrets and
other confidential information including ideas, inventions (whether or not patentable and whether or not reduced to practice), know-how,
negative know-how, research information, drawings, specifications, designs, plans, proposals, financial and marketing plans, employee
information, customer and supplier lists, and related information and marketing materials; and (vi) other intellectual property rights.
“Net Sales”
means the gross amount actually received by GlobeStar in the Primary or Secondary Activity, or by SMIHC in the SMIHC Territory, from the
sale, lease, license or other transfer of GTC Products to
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a customer Introduced by AIP during the period from
the Introduction of the customer by AIP through the date seven (7) years thereafter, less the following deductions to the extent applicable
with respect to such sales, leases or other transfers and not previously deducted from the gross invoice price: (i) trade, quantity or
cash discounts and rebates to the extent actually allowed and taken; (ii) amounts repaid or credited by reason of rejection or return
of any previously sold, leased or otherwise transferred GTC Products; (iii) freight, transit, or insurance charges; and (iv) any sales,
value added or similar taxes, custom duties or other similar governmental charges, excluding taxes in the nature of income or profits
taxes.
“NGO Group”
means (i) the International Monetary Fund, World Bank, World Health Organization, United Nations and other multilateral and international
aid agencies and organizations, wherever located and wherever they may provide assistance; and (ii) Government relief and support agencies
with respect to their relief operations for countries other than Canada, the United States, United Kingdom, and members of the European
Union.
“Person” means
any natural individual, legal person, firm, corporation, limited liability company, limited partnership, association, trust, charity,
government department, agency, unit or other entity, or any other group or entity.
“Phase A”
means the Term from the execution of the Agreement and until the Trigger Date, if any.
“Phase B”
means the remainder of the Term after the Trigger Date, if any.
“Primary Territory”
means the world, excluding the SMIHC Territory.
“Process”
or “Processed” means obtaining, recording, holding or storing Data, or carrying out any operation or set of operations
on Data, including organizing, adapting, altering, retrieving, disclosing, transmitting, disseminating, making available, aligning, combining,
blocking, erasing, or destroying Data.
“Regulatory Authority”
means any applicable government authority involved in granting approvals for the manufacturing, distribution, or marketing of a GTC Product.
“Rule” means
any applicable law, rule, regulation, court order, or other provision, order, decree, executive or judicial actions or pronouncements,
judgements, or the equivalent having the force of law.
“SMIHC Territory”
means the countries listed in Appendix B hereto, as the same may be modified from time-to-time by mutual agreement of SMIHC and
GlobeStar, and the NGO Group, wherever located.
“Term” means
the period from the execution of the Agreement and until four (4) years thereafter, unless terminated or extended by the Parties as provided
for in the Agreement.
“Trigger Date”
means the date specified by GlobeStar by Notice to AIP. GlobeStar intends to send such Notice after it has obtained (i) results of the
Initial Clinical Trial, and (ii) sufficient financing to proceed with the second phase of activities with SMIHC, as described in GlobeStar’s
press release dated September 28, 2023. GlobeStar makes no representation that there will be a Trigger Date.
“Work Order”
means each fully executed and delivered statement of work for Additional Services, and each fully executed and delivered Change Order.
Unless the Parties agree otherwise, each Work Order will include a description of services, deliverables, timeline, compensation with
respect thereto and such other matters as the Parties consider appropriate. This Agreement constitutes the Work Order for Phase A Services
and Phase B Services.
2. Certain
Matters:
2.1. No
Ownership Rights. Nothing in this Agreement will be construed to confer any ownership interest to AIP in: (i) GTC-IP, (ii) other patents
obtained by GlobeStar, or (iii) any other inventions or Intellectual
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Property Rights now or hereafter developed, owned,
licensed or acquired by GlobeStar. Except as expressly set forth in this Agreement, as between the Parties, GlobeStar owns all right,
title, and interest in and to GTC-IP and any other products or technology created or developed by GlobeStar, whether pursuant to this
Agreement, or otherwise and whether created or developed by GlobeStar or on its behalf.
2.2. Control.
Except as set forth in this Agreement, as between the Parties, GlobeStar has the final decision as to the matters for which AIP renders
AIP Services hereunder, and the services to be rendered, with such approval right to be exercised r in accordance with the Parties respective
rights and obligations hereunder, and SMIHC’s rights described herein. GlobeStar is responsible for any additional costs arising
from any delay or inconsistency in its decisions. Notwithstanding the foregoing, no Party shall be required to do or not do something
that violates any Applicable Law or its rights pursuant to this Agreement.
2.3. SMIHC.
AIP shall not approach any Person in the SMIHC Territory regarding any matter related to GlobeStar, the GTC Products, SMIHC, Clinical
Trials, regulatory approvals, investments in GlobeStar, intellectual property rights, manufacturing, or any other matter pertaining to
this Agreement without first making a full and complete disclosure to SMIHC, with a copy to GlobeStar, regarding the nature of the proposed
approach, and AIP’s financial interest therein and goals with respect thereto, and then receiving SMIHC’s written pre-approval
thereof by Notice to AIP, with a copy to GlobeStar, such approval to be determined by SMIHC in its sole discretion. As between AIP and
SMIHC, in the SMIHC Territory, SMIHC’s decisions are final. SMIHC is an intended third party beneficiary of this provision.
2.4. Not
Exclusive. GlobeStar is under no obligation to use AIP to perform AIP Services, or to accept any recommendations made by AIP. Without
restriction, GlobeStar may engage other Persons to provide some or all of the services to be provided by AIP hereunder, either at the
same time as AIP, or in lieu of AIP. AIP may undertake services for itself or third Parties at the same time as it is engaged hereunder,
provided only that during the Term. AIP shall not engage in services intended to promote or advance an MS therapeutic, other than GTC
Products, and AIP shall not undertake other services that interfere in its obligations pursuant to this Agreement.
2.5. Expenses.
As between AIP and GlobeStar, GlobeStar is responsible for: (i) reimbursing AIP’s pre-approved travel, lodging, external duplication,
paid per inquiry computer services, and similar pre-approved out-of-pocket business expenses incurred by AIP for the AIP Services; and
(ii) advancing, or arranging for third parties to pay, all fees, costs and expenses with respect to Clinical Trials; the preparation,
filing, prosecution, protection, defense, and maintenance of GlobeStar’s regulatory filings and Intellectual Property Rights filings;
manufacturing, including the fees, costs and expenses of each such manufacturer; and the distribution and shipment of GTC Products. Reimbursement
will be made within fifteen (15) days after AIP delivers to GlobeStar an invoice with substantiating documentation in accordance with
GlobeStar policy.
2.6. Notifications.
Each Party shall promptly Notify the other of any material information pertinent to AIP’s ability to undertake its services pursuant
to this Agreement, including any technical or clinical advances, useful modifications, side effects, or new government regulations relating
to GTC-IP or GTC Products; and all actions and communications (even if believed to be without foundation) by or threatened by a regulatory
authority or other government authority relating to GTC-IP or GTC Products.
3. AIP
Services Generally:
3.1. Engagement.
Subject to the terms and conditions set forth in this Agreement: (i) GlobeStar hereby engages AIP to provide the Basic Services during
Phase A, (ii) if, but only if, GlobeStar sends a Trigger Notice, Basic Services during Phase B, and (iii) if, but only if, the Parties
enter into Work Orders for Additional Services, the Additional Services provided for in such Work Orders.
3.2. “Basic
Services” consist of the following services:
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3.2.1. During
Phase A, AIP’s Basic Services shall consist of AIP’s providing an average of five (5) to seven (7) hours per week of advice
to GlobeStar, SMIHC, consultants and counsel on the following subjects: (i) the Initial Clinical Trial, with a focus on recommending
to SMIHC potential Medical Institutions (as defined below) to participate in the initial Clinical Trial, proving feedback to SMIHC on
Medical Institutions it is considering, design of the study, and sourcing of patients; and (ii) regulatory strategy, intellectual property
strategy, manufacturing strategy, and sales and distribution strategy, with a focus on the Primary Territory and, to the extent requested
by SMIHC, also the SMIHC Territory. During Phase A, AIP personnel shall not be required to travel and generally will provide advice by
email and phone. Neither GlobeStar nor SMIHC are obligated to act on AIP’s advice and recommendations. All such Basic Services shall
comply with AIP’s obligations set forth in this Agreement.
3.2.2. During
Phase B, AIP’s Basic Services shall consist of AIP continuing to provide Phase A services, and also providing the Clinical Trial
services described in Section 4, regulatory services described in Section 5, Intellectual Property Rights services described in Section
6, manufacturing services described in Section 7, sales services described in Section 8, and Other Services described in Section 9. During
Phase B, AIP personnel shall undertake such travel, meetings, and other activities as are reasonably necessary to perform the Basic Services.
All such Basic Services shall comply with AIP’s obligations set forth in this Agreement, including as to pre-approval of travel.
3.3. Additional
Services. From time-to-time AIP and GlobeStar may agree on Work Orders for Additional Services. Upon execution and delivery by the
Parties of a Work Order, AIP shall commence its services with respect thereto in accordance with such Work Order and this Agreement. Except
as specified in the Work Order, all Additional Services shall comply with AIP’s obligations set forth in this Agreement, including
as to pre-approval of travel.
3.4. Change
Orders. If in either Party's reasonable judgment there is a material change in the scope, duration, requirements, assumptions or dependencies
described in a Work Order, the Parties shall negotiate an appropriate Change Order with respect thereto. Unless the context in this Agreement
requires otherwise: (i) each reference herein to a Work Order means and includes Change Orders with respect thereto, and (ii) each reference
generally to Work Orders means and includes Change Orders.
3.5. Reports.
At the request of either Party, AIP and GlobeStar will consult at least twice each month regarding the status and expectations for completion
of Phase A Services, Phase B Services and each Work Order.
3.6. Records.
AIP will maintain appropriate books and records concerning its performance of AIP Services for twenty-four (24) months from the completion
of the Term. Upon GlobeStar’s request, AIP either will provide copies thereof to GlobeStar, or permit GlobeStar to review copies
of such records at AIP’s offices upon reasonable notice and during AIP’s normal business hours. For clarity, AIP shall not
be required to render any particular number of hours of services, and AIP does not maintain or provide time records or similar reports
pertaining to its activities.
3.7. Consultation.
The Parties shall regularly consult regarding major issues to be determined by the Parties, or either of them, regarding the subject of
this Agreement.
3.8. Cooperation.
To facilitate performance of AIP Service, GlobeStar will endeavor to provide to AIP such data, facilities, resources, documentation and
other information necessary or appropriate to support the performance of AIP Services (“GlobeStar Responsibilities”).
AIP’s delay or nonperformance of AIP Services will be excused to the extent resulting from GlobeStar’s delay or nonperformance
of any GlobeStar Responsibilities. AIP shall use commercially reasonable workaround efforts.
3.9. Acceptance.
Upon completion of each Work Order, GlobeStar shall have thirty (30) days in which to accept or reject such AIP Services, unless the
Work Order provides a different acceptance period (in
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each case, the “Acceptance Period”).
If prior to expiration of the Acceptance Period GlobeStar provides AIP Notice specifying in reasonable detail the manner in which the
AIP deliverables do not substantially conform to the requirements of the Work Order, then AIP shall endeavor to remedy the deficiency.
Acceptance irrevocably shall be deemed to have occurred following expiration of the Acceptance Period absent a Notice of rejection delivered
prior thereto.
3.9.1. AIP
shall have sixty (60) days, or such other period provided in the Work Order to implement such changes as shall be reasonably required
to bring the deficient deliverables into substantial conformity with the requirements of the Work Order. In the event the corrected AIP
Services do not substantially conform to the requirements of the Work Order after a second sixty (60) day period, GlobeStar may, in its
sole discretion: (i) accept the non-conforming deliverables, (ii) negotiate a discount in related Management Fees for the non-conforming
work; (iii) require that AIP make additional corrections to the deliverables according to a schedule mutually agreed upon by the Parties;
or (iv) terminate the applicable Work Order and receive a refund of all pre-paid amounts corresponding to the non-conforming deliverables.
4. Clinical
Trials:
4.1. AIP
Services - Generally. As requested by GlobeStar, the Parties will consult regarding all matters pertaining to Clinical Trials in the
Primary Territory, including the number, purpose, scope, design, potential Medical Institutions, potential participants, location, budget
and timing. To the extent requested to do so by GlobeStar, AIP will analyze the foregoing, make recommendations with respect thereto,
and execute plans approved of by GlobeStar. As requested by SMIHC from time-to-time, AIP also will render similar services to the extent
requested by SMIHC with respect to Clinical Trials in the SMIHC Territory.
4.2. AIP
Services - Medical Institutions. AIP shall recommend to GlobeStar one or more medical institutions, medical professions, or other
facilities (collectively, herein referred to as “Medical Institutions”) that might participate in, facilitate, or undertake,
all or a portion of the Clinical Trials for GTC Products in the Primary Territory. With assistance of GlobeStar and its other advisors
and counsel, following GlobeStar’s approval as to the Medical Institution or institutions that might participate in or undertake
each Clinical Trial in the Primary Territory, to the extent directed by GlobeStar to do so, AIP will endeavor to negotiate, or participate
in negotiating, the terms on which each such Medical Institution participates in or undertakes the applicable Clinical Trial or Trials.
As requested by SMIHC from time-to-time, AIP also will render the foregoing services for SMIHC with respect to the foregoing subjects
pertaining to Clinical Trials in the SMIHC Territory.
4.3. Design.
With respect to each Clinical Trial in the Primary Territory, GlobeStar, the Medical Institutions selected to participate in or undertake
that Clinical Trial, and outside experts selected by GlobeStar and AIP will collaborate in the requirements, scope, design and budget
of each Clinical Trial. As requested by SMIHC from time-to-time, AIP also will render the foregoing services for SMIHC with respect to
the foregoing subjects pertaining to Clinical Trials in the SMIHC Territory.
5. Regulatory
Matters: With respect to the Primary Territory, AIP shall recommend to GlobeStar strategy and actions regarding regulatory matters
relating to or involving GTC-IP and GTC Products, and will assist GlobeStar with respect thereto by, among other things as GlobeStar may
from time-to-time request: (i) recommend counsel and experts, (ii) supervise and collaborate with counsel and experts to prepare
necessary filings, (iii) lawfully liaise with regulators and others to advance GlobeStar’s regulatory objectives; (iv) monitor
studies pertinent to the regulatory matters; and (v) otherwise endeavor, with the cooperation and contributions of GlobeStar, such counsel
and experts, to obtain regulatory approvals, as deemed necessary by GlobeStar. As requested by SMIHC from time-to-time, AIP also will
render the foregoing services for SMIHC for the SMIHC Territory.
6. Intellectual
Property Rights Services: With respect to the Primary Territory, AIP shall recommend to GlobeStar strategy and actions regarding the
preparation, filing, prosecution, protection, defense and maintenance of Intellectual Property Rights in GTC-IP and GTC Products, including
patents, copyrights and
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trademarks, and will assist GlobeStar with respect
thereto by, among other things as GlobeStar may from time-to-time request: (i) recommend counsel and experts, (ii) supervise and
collaborate with counsel and experts to prepare necessary filings, (iii) lawfully liaise with regulators and others to advance GlobeStar’s
regulatory objectives; and (iv) otherwise endeavor, with the cooperation and contributions of GlobeStar, such counsel and experts, to
obtain regulatory approvals in the Primary Territory, as reasonably deemed necessary by GlobeStar. As requested by SMIHC from time-to-time,
AIP also will render the foregoing services for SMIHC for the SMIHC Territory.
7. Manufacturing:
With respect to the Primary Territory, AIP shall recommend to GlobeStar strategy and actions regarding manufacturing, and shall recommend
manufacturers. As requested by SMIHC from time-to-time, AIP also will render the foregoing services for SMIHC for the SMIHC Territory.
8. Sale
of GTC Products: AIP will consult with GlobeStar with respect to potential customers, distributors and sales agents located in the
Primary Territory with whom AIP has a pre-existing relationship. With respect to the Primary Territory, AIP will not contact third Persons
with respect to the foregoing without first securing GlobeStar’s written pre-approval, and thereafter AIP shall contact such third
Persons as directed by GlobeStar to do, and in coordination with GlobeStar and such Persons as GlobeStar may direct. With respect to the
SMIHC Territory, if AIP has a pre-existing relationship with a potential customer, distributor or sales agent, AIP shall advise SMIHC,
and will not contact that Persons without first securing SMIHC’s written pre-approval, and thereafter AIP shall contact such third
Persons in the SMIHC Territory as directed by SMIHC to do, and in coordination with SMIHC and such Persons as SMIHC may direct. If GlobeStar,
or SMIHC, as applicable, approves of AIP’s contacting the third Person, GlobeStar or SMIHC either shall provide to AIP information
on prices and terms of sale, or shall designate a Persons to whom AIP may direct the third Person for such information. With respect to
the foregoing activities, generally, each Party shall be responsible for its own expenses, unless GlobeStar specifically agrees in writing
to reimburse certain specified expenses for AIP.
9. Other
Services: As requested by GlobeStar from time-to-time, AIP shall use its best efforts to and introduce potential partners, collaborators,
or investors with which AIP has a pre-existing relationship located in the Primary Territory who may contribute to the success of GlobeStar
and GTC Products. AIP will not contact third Persons with respect to the foregoing without securing GlobeStar’s written pre-approval,
and thereafter AIP shall contact such third Persons as directed by GlobeStar to do, and in coordination with GlobeStar and such Persons
as GlobeStar may direct. If AIP identifies a potential partner, collaborator, or investor with which AIP has a pre-existing relationship
located in the SMIHC Territory, AIP will not contact such Person with respect to GlobeStar, SMIHC, or GTC Products without first securing
SMIHC’s written pre-approval, and thereafter AIP shall contact such third Persons as directed by SMIHC to do, and in coordination
with SMIHC and such Persons as SMIHC may direct. With respect to the foregoing activities, generally, each Party shall be responsible
for its own expenses, unless GlobeStar specifically agrees in writing to reimburse certain specified expenses for AIP.
10. Base
Compensation and Commissions: Provided AIP performs its representations, warranties, covenants and obligations pursuant to this Agreement
and is not in breach or default thereof, GlobeStar shall pay the following base compensation and commissions to AIP:
10.1. Base
Compensation: For services rendered during the Term, GlobeStar will pay AIP the following base compensation during the Term:
10.1.1. Phase
A: Five thousand dollars ($5,000) for each month of the Phase A Term during which AIP renders services as required herein, with payment
deferred and paid if, but only if, GlobeStar receives regulatory approval to manufacture, sell and distribute GTC Products in either India
or the United States, within sixty (60) days thereafter, provided that payment for the first month will be made within sixty (60) days
after execution of this Agreement and issuance of a press release pertaining thereto.
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10.1.2. Phase
B: Provided there is a Phase B hereunder, six thousand dollars ($6,000) per month for each month of Phase B during which AIP renders
services as required herein, payable by the last day of each such month.
10.1.3. Additional
Services/Work Orders: As provided in the applicable Work Order, payable as provided for therein.
10.2. Sales
Commissions: For the following services rendered by AIP during the Term in accordance with this Agreement, GlobeStar will pay AIP
the following commissions in accordance with Section 12 during the Term and thereafter to the extent specified in Section 13.2:
10.2.1. If, with
GlobeStar’s consent, AIP introduces GlobeStar to a customer in the Primary Territory and/or Primary Territory for GTC Products,
a commission equal to fifteen percent (15%) of GlobeStar’s Net Sales therefrom received by GlobeStar from the date of the introduction
through the date seven years thereafter.
10.2.2. If, with
GlobeStar’s consent, AIP introduces GlobeStar to a distributor or sales agent in the Primary Territory and/or Primary Territory
for GTC Products, a commission equal to ten percent (10%) of GlobeStar’s Net Sales from GTC Products sold by the distributor or
sales agent in the Primary Territory and received by GlobeStar from the date of the introduction through the date seven years thereafter.
10.2.3. If, with
SMIHC’s consent, AIP introduces SMIHC to a customer in the SMIHC Territory for GTC Products, a commission equal to fifteen percent
(15%) of SMIHC’s Net Sales therefrom received by SMIHC from the date of the introduction through the date seven years thereafter.
10.2.4. If, with
SMIHC’s consent, AIP introduces SMIHC to a distributor or sales agent in the SMIHC Territory for GTC Products, a commission equal
to ten percent (10%) of SMIHC’s Net Sales from GTC Products sold by the distributor or sales agent in the SMIHC Territory and received
by SMIHC from the date of the introduction through the date seven years thereafter.
10.3. Investor
Commissions: With respect to the net amount of any equity investment or loan from Persons introduced during the Term by AIP to GlobeStar,
and received within two (2) years after the introduction (whether during or, except as specified in Section 13.2, after the Term): subject
to compliance with applicable law, within thirty (30) days after receipt of such funds by GlobeStar, GlobeStar will pay AIP a commission
equal to four percent (4%) of the net amount received as an equity investment and two percent (2%) of the net amount received as a loan,
provided that the commission will be payable only if the introduction was pre-approved by GlobeStar, and if the investor was located in
the SMIHC Territory, if the introduction also was pre-approved by SMIHC. As used herein, “net amount” means the amount of
the investment or loan, reduced by all fees, points, commissions and expenses associated with obtaining, negotiating and receiving such
investment or loan.
10.4. Strategic
Partner Commissions: With respect to any transaction entered into by GlobeStar with Persons introduced during the Term by AIP to GlobeStar
within two (2) years after the introduction (whether during or, except as specified in Section 13.2, after the Term): subject to compliance
with applicable law, in Section 12, GlobeStar will pay AIP a commission equal to five percent (5%) of GlobeStar’s after-tax profit
from that transaction (as computed by GlobeStar’s tax accountant), except as specified in Section 13.2, during the period from the
introduction through the date seven years after the introduction, provided that the commission will be payable only if the introduction
was pre-approved by GlobeStar, and if the strategic partner was located in the SMIHC Territory, if the introduction also was pre-approved
by SMIHC.
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11. Bonus
Compensation: Provided AIP performs its representations, warranties, covenants and obligations pursuant to this Agreement and is not
in breach or default thereof and provided AIP renders material services in respect of the subjects of the following potential bonuses
during the Term, GlobeStar shall have the right, but not the obligation, to pay the following applicable amounts to AIP:
11.1. Clinical
Trials: If applicable, GlobeStar may pay AIP up to both of the following bonuses for each Clinical Trial to which AIP makes a material
contribution, as determined by GlobeStar:
11.1.1. For each
Clinical Trial for which AIP materially contributes to identifying and arranging the Medical Institutions and other key professionals
involved in undertaking and completing the Clinical Trial, within thirty (30) days after the conclusion of the Clinical Trial, GlobeStar
may pay AIP a bonus of up to twenty thousand dollars ($20,000) if the Clinical Trial is in the Primary Territory, and ten thousand dollars
($10,000) if the Clinical Trial is in the SMIHC Territory.
11.1.2. For each
Clinical Trial for which AIP materially contributes to the planning, design, execution and oversight, within thirty (30) days after the
conclusion of the Clinical Trial, GlobeStar may pay AIP a bonus up to the larger of five percent (5%) of the cost of that Clinical Trial,
or twenty thousand dollars ($20,000) if the Clinical Trial is in the Primary Territory, or the larger of two and one-half percent (2.5%)
of the cost of that Clinical Trial, or ten thousand dollars ($10,000) if the Clinical Trial is in the SMIHC Territory.
11.2. Patient
Doses: If applicable, GlobeStar may pay AIP up to each of the following bonuses once during the Term, as determined by GlobeStar:
11.2.1. Within
thirty (30) days after the first patient dose of a GTC Product is administered in a Phase 1 Clinical Trial: five thousand dollars ($5,000).
11.2.2. Within
thirty (30) days after the first patient dose of a GTC Product is administered in a Phase 2 Clinical Trial: ten thousand dollars ($10,000).
11.2.3. Within
thirty (30) days after the first patient dose of a GTC Product is administered in a Phase 3 Clinical Trial: ten thousand dollars ($10,000).
11.3. FDA:
If applicable, GlobeStar may pay AIP up to each of the following bonuses once during the Term, as determined by GlobeStar:
11.3.1. Initial
FDA Submission, if any: twenty-five thousand dollars ($25,000), payable within thirty (30) days thereafter.
11.3.2. Initial
IND Approval from FDA in the United States, if any: twenty-five thousand dollars ($25,000), payable within thirty (30) days thereafter.
11.3.3. Initial
Marketing Authorization from FDA via 505(b)(2) authorization, or otherwise, if any: twenty-five thousand dollars ($25,000), payable within
thirty (30) days thereafter.
11.4. Potential
Country Bonuses: If applicable, GlobeStar may pay AIP up to each of the following bonuses once during the Term for each country or
other territory, as determined by GlobeStar:
11.4.1. For each
of Brazil, China, Japan, European Union, United Kingdom, United States for which AIP develops the strategy and provides material assistance
in developing and executing the regulatory and intellectual property rights strategy, within ninety (90) days after the second to occur
of authorization to manufacture, sell and distribute GTC Products in that territory, and the sale of at least $100,000 of GTC Products
in that territory: up to $75,000. For this purpose, the European Union constitutes one country, provided that the payment described herein
will be due only if the approvals include at least sixty percent (60%) of the European Union population.
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11.4.2. For each
country in the Primary Territory not included in Section 11.3 for which AIP develops the strategy and provides material assistance in
developing and executing the regulatory and intellectual property rights strategy, within ninety (90) days after the second to occur of
authorization to manufacture, sell and distribute GTC Products in that country, and the sale of at least $100,000 of GTC Products in that
country: up to $25,000. For this purpose, all countries in the European Union are a single area included in Section 11.4.1.
12. Certain
Payment Procedures:
12.1. Accounting
Reports; Incontestability. Within ninety (90) days after the conclusion of each of the first three calendar quarters of the year and
one hundred twenty days (120) days after the conclusion of the last calendar quarter of the year and until completion of the payment obligations
pursuant to Sections 10.2, 10.3, and 10.4 hereof, whether during or after the Term, GlobeStar shall render a report to AIP of Net Sales
for which commissions are payable to AIP pursuant to Sections 10.2 and 10.3, and within thirty (30) days after completing its taxes for
the relevant year, GlobeStar will render a report to AIP for any commission payable to AIP pursuant to Section 10.4. Any accountings rendered
hereunder may be altered to cure omissions or errors. GlobeStar may maintain reasonable reserves for future expenses deductible in the
computations included in the reports. Unless AIP commences an arbitration, or GlobeStar agrees otherwise, all amounts included in a report
will become incontestable, and will not be subject to challenge, commencing two years after the first report on which such amounts were
initially reported.
12.2. Payment.
To the extent local authorities permit the payment of the commissions payable to AIP to be made funds generated in that country,
within thirty (30) days after issuance of a report, GlobeStar shall pay any commission due to AIP in U.S. dollars by wire transfer. Except
as permitted by the foregoing sentence, any commission payment that is not paid within thirty (30) days after the date such payment is
due will bear interest at the lower of (i) one-half percent (.5%) per month, or part of a month, and (ii) the maximum rate allowed by
law. Interest will accrue beginning on the first day following the due date of payment and will be compounded monthly.
12.3. SMIHC
not Liable. In no event shall SMIHC have any liability to either Party pursuant to this Agreement. Without limiting the foregoing,
AIP hereby waives and releases any claim against SMIHC arising out of or relating to this Agreement, including as to any future act or
omission by SMIHC is the exercise or non-exercise by SMIHC of the rights this Agreement specifies may be exercised by SMIHC with regard
to AIP. In the event AIP believes that any act or omission by SMIHC is a breach of GlobeStar’s obligations hereunder, or gives rise
to an obligation hereunder, including payment of fees for an introduction or transaction, the sole obligor with respect thereto is GlobeStar,
and AIP’s sole recourse is against GlobeStar. SMIHC is an intended third party beneficiary of this provision.
13. Termination
of Term:
13.1. Termination
Process.
13.1.1. Termination
by Both Parties. The Parties may terminate the Term by mutual written agreement on such terms as they may mutually agree in that agreement.
13.1.2. Termination
by Either Party. Either Party may terminate the Term by Notice to the other Party as follows: (i) if the other Party liquidates its
assets, or suspends, ceases or dissolves its business; (ii) if the other Party commits a material breach of the Agreement and fails to
cure that breach within thirty (30) days after receiving Notice thereof; or (iii) without cause, on prior Notice of six (6) months, provided
that GlobeStar may elect to reduce the Notice period and instead pay AIP for its Base Compensation through the sooner of the Normal End
of the Term, or the balance of the six (6) months, and if Phase A continues for more than nine (9) months, AIP may thereafter, until commencement
of Phase B, terminate the Term on prior Notice of thirty (30) days.
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13.2. Effect
of Termination. On the termination of the Term for any reason, AIP will cease rendering services, and return to GlobeStar all copies
of Confidential Information and any GlobeStar or SMIHC property or software in AIP’s possession. Within thirty (30) days after the
termination date, GlobeStar will reimburse any remaining expenses for which proper documentation has been supplied to GlobeStar and any
remaining Base Compensation due and payable through the termination date. Thereafter: (i) unless AIP terminated the Term, or GlobeStar
terminated the Term pursuant to clauses (i) or (ii) of Section 13.1.2, payment of commissions to AIP for introductions pertaining to sales,
investors and strategic partners pursuant to Sections 10.2, 10.3, and 10.4 will continue until the end of the respective periods set forth
in such sections; or (ii) if AIP terminated the Term, or GlobeStar terminated the Term pursuant to clauses (i) or (ii) of Section 13.1.2,
payment of commissions to AIP pursuant to Sections 10.2, 10.3, and 10.4 will cease on the last day of the Term. The Parties’ respective
rights, obligations, and duties under Sections 1, 13.2, 16, 17, and 18.2 through 21 shall survive any expiration or termination of the
Term. No termination is a waiver of rights by either Party with respect to any disputes between them.
14. Compliance
with Law: During the Term, each Party represents and warrants that it will comply with all local, state, federal and international
laws and regulations relating to the development, manufacture, use, sale and importation of products and services. Without limiting the
foregoing, each Party represents and warrants that it shall comply with all laws and regulations controlling the export of certain commodities
and technical data, including without limitation all Export Administration Regulations of the United States Department of Commerce. Among
other things, these laws and regulations prohibit or require a license for the export of certain types of commodities and technical data
to specified countries. Each Party hereby gives written assurance that it will comply with all United States export control laws and regulations.
15. Data
Security: During the Term, each Party will comply with any applicable data protection and privacy legislation in force anywhere in
India and the United States and shall (i) establish and maintain appropriate administrative, technical and physical safeguards to protect
the security, integrity, confidentiality and availability of Data; (ii) protect against any actual or anticipated threats, hazards, viruses,
unauthorized or unlawful access to, use of, or disclosure of, Data; (iii) within seventy-two (72) hours Notify the other Party of any
actual or suspected breach of this Section 15, if any Data is or is suspected to be lost, stolen, corrupted, used or disclosed to any
Third Person except in accordance with this Agreement and fully cooperate with the other Party to investigate and resolve any such Data
event; (iv) ensure that those to whom the Party provides access to Data are aware of and comply with the provisions of this Section 15;
and (v) maintain, and upon request provide the other Party with a copy of, data privacy, security, and disaster recovery policies and
procedures applicable to such Data.
16. Confidentiality:
16.1. Definition.
“Confidential Information” means all information that is of a confidential and proprietary nature to GlobeStar
or AIP and provided by one Party (the "Discloser") to the other Party (the "Recipient"), provided that
information shall not be considered Confidential Information of a Discloser under this Agreement to the extent that the Recipient can
establish by competent written proof that such information: (i) was in the public domain at the time of disclosure; or (ii) later became
part of the public domain through no act or omission of the Receiving Party, its employees, agents, successors or assigns in breach of
this Agreement; or (iii) was lawfully disclosed to the Receiving Party by a Third Person having the right to disclose such information
not under an obligation of confidentiality; or (iv) was already known by the Receiving Party at the time of disclosure; or (v) was independently
developed by the Recipient without use of the Discloser’s Confidential Information.
16.2. Protection
and Marking. During the Term with respect to GlobeStar, and during the Term and for a period of ten (10) years thereafter with respect
to AIP, all Confidential Information disclosed by Discloser in tangible form, and marked “confidential” and forwarded to the
Recipient, or if disclosed orally, is designated as confidential at the time of disclosure: (i) is to be held in strict confidence by
the Recipient,
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(ii) is to be used by the Recipient only as authorized
in this Agreement, and (iii) shall not be disclosed to any Third Person by the Recipient without the prior written consent of the Discloser
or as authorized in this Agreement. Each Party has the right to use and disclose Confidential Information of the other Party reasonably
in connection with the exercise of its rights under this Agreement, including without limitation disclosing to subsidiaries, investors,
insurers, acquirers, potential investors, insurers and acquirers, SMIHC, and others on a need to know basis, and under conditions which
reasonably protect the confidentiality thereof.
16.3. Disclosure
Required. If the Recipient is required to disclose Discloser's Confidential Information, or any terms of this Agreement, pursuant
to the order or requirement of a Regulatory Authority, court, administrative agency, or other governmental body or applicable Rule, the
Recipient may disclose such Confidential Information or terms to the extent required, provided that the Recipient shall use reasonable
efforts to provide the Discloser with reasonable advance Notice thereof to enable the Discloser to seek a protective order and otherwise
seek to prevent such disclosure. To the extent that Confidential Information so disclosed does not become part of the public domain by
virtue of such disclosure, it shall remain Confidential Information protected pursuant to this Section.
16.4. Publicity.
Notwithstanding the foregoing, each Party may issue press releases and otherwise advertise and publicize its activities under this
Agreement, provided that: (i) AIP may not issue press releases pertaining to GlobeStar, this Agreement or activities pursuant hereto without
the prior consent of GlobeStar, or SMIHC or an affiliate of SMIHC without the prior consent of SMIHC. The foregoing is not intended to
prohibit the Parties and their officers, directors and advisors from engaging in lawful public communications that accurately describe
and lawfully promote the Parties’ business activities pursuant to this Agreement, provided that the Parties shall not thereby disclose
Confidential Information.
17. Non-Solicitation:
Unless otherwise agreed in writing by the Parties, during the Term and for a period of one (1) year after termination of the Term,
neither Party shall directly or indirectly, engage, employ or solicit to employ or engage as a consultant or other independent contractor,
on their own behalf or on behalf of any other Person, the personal services of any individual who was employed by the other Party with
respect to the activities described herein, unless and until that individual ceases to be employed by such Party for a period of at least
one (1) year. In the event of any violation of this provision, as liquidated damages, the Party violating this provision shall pay the
sum of $500,000 per occurrence to the other Party.
18. Representations
and Warranties:
18.1. Each
Party hereby represents and warrants and covenants to the other Party as of the date hereof as follows:
18.1.1. Such
Party is an entity duly organized, validly existing, and in good standing under the laws of the jurisdiction of its organization as set
forth in the introduction to this Agreement, with all requisite authority to enter into and perform its obligations under this Agreement.
18.1.2. Such
Party has taken or caused to be taken all necessary actions to authorize the execution, delivery, and performance of this Agreement, and
this Agreement constitutes a valid and binding obligation of such Party enforceable in accordance with its terms.
18.1.3. The signatory
for such Party has full authority to sign on behalf of such Party.
18.1.4. Such
Party has the right to enter into this Agreement without the approval or consent of any Third Person.
18.1.5. The execution
and delivery of this Agreement by such Party and the performance by it of its obligations hereunder do not and will not (i) violate any
Rule, license, or agreement applicable to such Party, or (ii) contravene any provision of, or constitute an event of default under any
contract, agreement,
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instrument or undertaking to which such Party is
a party, or violate such Party’s articles of incorporation or bylaws.
18.2. AIP
further represents, warrants, and covenants that (i) it will perform AIP Services in a professional and workmanlike manner, consistent
with generally accepted industry standards and good commercial practices; and (ii) except as expressly set forth in the applicable Work
Order, all materials developed during the course of performing AIP Services and delivered pursuant to a Work Order shall not infringe
the rights of Third Persons and shall be delivered to GlobeStar free and clear of any liens.
19. Indemnification:
Each Party will defend, indemnify, and hold harmless the other Party, SMIHC, and their respective subsidiaries and licensees and the owners,
directors, officers, employees, counsel, advisors, agents and representatives of each of the foregoing (the “Indemnified Parties”),
from and against any and all claims, causes of action, lawsuits or other proceedings filed or otherwise instituted against any of the
Indemnified Parties arising out of or related to a breach of any representation, warranty, covenant or obligation of that Party under
this Agreement.
20. Dispute
Resolution:
20.1. AAA.
Any dispute, controversy or claim involving, arising out of or related to the validity, interpretation, application or enforcement of
this Agreement or the transactions contemplated hereby, or any breach or application hereof or tort related hereto, including as to this
Agreement’s existence and the validity, termination, scope or enforceability of this agreement to arbitrate (collectively a “Dispute”),
shall be exclusively resolved by binding arbitration before the American Arbitration Association (“AAA”), whose rules
applicable to commercial disputes shall apply, except as modified by this Agreement, and are hereby deemed to be incorporated herein by
this reference. Service of any papers with respect to such arbitration may be effected by delivering any required papers in the manner
described herein for Notices. The arbitration hearing shall take place in Los Angeles County, California, USA and the Parties consent
to venue. The arbitration shall take place before one arbitrator, who shall be a retired judge. The language of arbitration shall be English
and the arbitral award shall be final and binding on the Parties. The arbitrator shall have the right to order equitable relief, including
a temporary restraining order, preliminary injunction, injunction and specific performance, and to award reasonable costs and expenses,
including reasonable attorneys’ fees and expert witness fees, to the prevailing party. The cost of the arbitration shall be paid
by the substantially losing party. Each of the Parties irrevocably submits to the exclusive jurisdiction of such arbitration proceeding,
waives any and all objections it may now or hereafter have based on jurisdiction, venue, convenience of forum, or proceedings described
herein and agrees that all claims in respect of such proceeding shall be heard and determined only by such arbitrator, and agrees not
to bring any proceeding arising out of or relating to this Agreement in any other court or tribunal. Counsel, parties and witnesses not
located in the city in which the arbitration occurs may be deposed and appear at hearings remotely by videotelephony or online peer-to-peer
services such as Zoom, Microsoft Teams and Skype. If there is no agreement on an arbitrator within 60 days after AAA provides a list of
proposed arbitrators, then AAA shall appoint the arbitrator. The arbitrator shall comply with the provisions of this Section unless the
parties to the arbitration consent in writing otherwise. THE PARTIES UNDERSTAND AND ACKNOWLEDGE THAT UNDER THIS SECTION EACH WAIVES THE
RIGHT TO TRIAL BY JURY. The award of the arbitrator may be entered with any court whose jurisdiction covers the venue of the arbitration
proceeding and such judgment may be enforced with the same force of law as the non-appealable judgment of a U.S. federal court and may
be enforced worldwide against the parties and their assets. To the maximum extent permitted by applicable Rule, each Party hereby waives
and covenants not to assert any defenses regarding the worldwide enforcement of a judgment hereunder, other than the defense that there
has been a prior payment of the judgment, in whole or in part.
20.2. Confidentiality.
The Parties shall maintain the confidential nature of the arbitration proceeding, except as may be necessary to prepare for or conduct
the arbitration hearing, as may be
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necessary in connection with a court application
for a preliminary remedy, a judicial challenge to an award, the entry of an award in any court having jurisdiction thereof, the enforcement
or the award, or as required by law or judicial decision.
20.3. Court.
If for any reason this Section 20 shall not be sufficient or enforceable as the exclusive means of resolving any and all disputes relating
to this Agreement or any rights created hereby, then all such matters shall be adjudicated exclusively by state or federal courts in Los
Angeles County, State of California, USA. Each Party agrees to submit to the jurisdiction of, and agrees that venue is proper in, Los
Angeles County for any such legal action or proceeding.
20.4. Exception.
The arbitration provision herein shall not apply in the event a lawsuit is brought against both Parties by a Third Person; in such an
event, a Party may file a cross-complaint in the same suit if the claim of the cross-complaint arises out of the transaction or occurrence
that is the subject matter of the original action or of a counterclaim.
21. General
Provisions:
21.1. Reference
to Agreement and Sections. The words “hereof,” “herein” and “hereunder” and words of similar import
when used in this Agreement shall refer to this Agreement as a whole and not to any particular provision of this Agreement. Any reference
to this Agreement includes any and all recitals, permitted amendments, supplements, extensions, and renewals of this Agreement, including
each Work Order, provided that unless expressly stated, references to sections within the main portion of this Agreement or any appendix,
or Work Order refers to the sections of that portion of this Agreement.
21.2. Construction.
In this Agreement, unless the context clearly requires otherwise: (i) the plural and singular numbers shall each be deemed to include
the other; (ii) the masculine, feminine and neuter genders shall each be deemed to include the others; (iii) “shall,” “will”
or “agrees” are mandatory and “may” is permissive; (iv) “or” is not exclusive; (v) “includes”
and “including” are not limiting and mean “without limitation;” (vi) “anticipates” and “anticipated”
means that there is a current expectation or belief, but not a binding obligation; and (vii) “promptly” means within five
(5) business days after request, unless the exigencies of the situation require a shorter period. Except as expressly set forth herein,
all references to currency are to U.S. Dollars. Unless otherwise indicated in this Agreement, all accounting terms used in this Agreement
shall be construed, and all accounting and financial computations hereunder or thereunder shall be computed, in accordance with United
States generally accepted accounting principles, applied in a consistent manner.
21.3. Interpretation.
Each Party has had access to legal counsel of its choice prior to the execution of this Agreement and has obtained such advice as it has
required to understand and negotiate this Agreement. Accordingly, this Agreement shall not be construed or resolved using any presumption
against any Party. Any ambiguity or uncertainty shall be construed and interpreted according to the ordinary meaning of the words so as
to fairly accomplish the purposes and intention of the Parties. The Parties waive the benefit of any statute or principal providing that
in cases of uncertainty, language of a contract should be interpreted most strongly against the Party who caused the uncertainty to exist.
21.4. Assignment.
GlobeStar may delegate its responsibilities and may assign this Agreement. Any assignment is a novation. AIP may not delegate its
responsibilities or assig this Agreement, except upon the prior written consent of GlobeStar. Subject to the foregoing, this Agreement
shall be binding upon and inure to the benefit of the Parties and their respective legal representatives, successors, and assigns.
21.5. Third-Party
Beneficiaries and Liability. Except as described in this Agreement, no Third Person is a beneficiary of this Agreement and no Third
Person, including SMIHC, is a guarantor of the performance by either Party to this Agreement, nor shall any Third Person, including SMIHC,
have any liability with respect to the performance by either Party to this Agreement. Indemnified Persons are intended Third
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Person beneficiaries of the indemnification provisions
of this Agreement. SMIHC is an intended third party beneficiary of this Agreement, but is not liable to AIP for the acts or omissions
of SMIHC, GlobeStar or AIP hereunder; as between GlobeStar and AIP, GlobeStar shall be liable for any act or omission of SMIHC that might
create an obligation to AIP.
21.6. No
Partnership. This Agreement does not create a partnership, joint venture or fiduciary relationship. Each Party’s obligation
to make payments to is that of a debtor only.
21.7. Documents.
Each Party shall promptly execute, acknowledge, deliver and file, or promptly procure the execution, acknowledgement, delivery and
filing, of any and all further agreements and instruments which may be necessary or expedient to effectuate the purposes of this Agreement.
21.8. Notices.
Except as required herein, all notices, consents, approvals and other communications hereunder, including the commencement or subsequent
communications pertaining to any arbitration or other legal proceeding arising hereunder (each, a “Notice”) shall be
in writing and shall be deemed to have been received only if and on the first business day after received (i) by personal delivery, (ii)
from an internationally recognized expedited courier service such as Federal Express, DHL or UPS, or (iii) as an “in the window”
email or a PDF attachment to an email, provided, however, that receipt of the email either is confirmed by an automatically generated
“read” receipt or by a return email from the recipient, or if the foregoing does not occur, the sender of the Notice also
sends a copy by regular mail posted in the United States, or personal delivery, or by an internationally recognized expedited courier
service such as Federal Express or UPS. Notwithstanding the foregoing, unless a Party in writing consents otherwise, all Notices are effective
only if also provided by email. Unless a Party notifies the other Parties of new Notice information, the Notice information is set forth
in the introductory paragraph to this Agreement. Required copies of each Notice shall concurrently be sent by email to etswanson@att.net.
21.9. Governing
Law. This Agreement will be governed by, and construed in accordance with, the substantive Rules of the State of California, USA without
giving effect to any choice or conflict of law provision, except that questions affecting the construction and effect of any patent, copyright
or trademark shall be determined by the Rules of the country in which the patent, copyright or trademark shall have been granted.
21.10. Costs relating
to this Agreement. Each Party shall be responsible for and shall pay all legal and accounting fees in connection with the drafting
and negotiation of this Agreement.
21.11. Severability.
If an arbitrator or other tribunal of competent jurisdiction holds any provision of this Agreement to be illegal, unenforceable or invalid
in whole or in part for any reason: (i) such provision shall be in good faith adjusted rather than voided, if possible, to achieve the
intent of the Parties, (ii) this Agreement shall be read as if the invalid, illegal or unenforceable words or provisions had to that extent
been deleted, and (iii) the validity and enforceability of the remainder of this Agreement shall not be affected thereby unless an essential
purpose of this Agreement would be defeated by the loss of the illegal, unenforceable, or invalid provisions.
21.12. Entire Agreement.
This Agreement expresses the complete and entire understanding of the Parties with respect to the subject matter hereof and supersedes
and merges all prior and contemporaneous agreements, dealings, negotiations, promises, representations and communications regarding its
subject matter (whether written or oral), between the Parties relating to the subject matter hereof other than the other agreements referenced
herein. There are no representations, warranties or other agreements between the Parties (whether express or implied) in connection with
the subject matter of this Agreement except as specifically set forth herein.
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21.13. Waiver;
Modifications. No provision may be modified, amended or waived, and no Party’s rights or remedies be waived, except by a writing
executed by authorized representatives of the Parties. Under no circumstance or conditions shall any other conduct be relied upon by the
Parties.
21.14. Counterparts
and Signature Validity. This Agreement may be executed in several counterparts and all counterparts so executed shall constitute
one agreement that is binding on all Parties, notwithstanding that all Parties are not signatories to the original or the same counterpart.
PDF signatures that are electronically transmitted shall be acceptable as if original signatures had been exchanged.
IN WITNESS WHEREOF, the
Parties have caused this Agreement to be executed by their duly authorized representatives as of the date first written above.
GlobeStar Therapeutics Inc.:
By: /s/ James C. Katzaroff
James C. Katzaroff, Chief Executive
Officer
Responsible Person: James C. Katzaroff
Address: 719 Jadwin Ave, Richland, Washington
99352
Email: jim@katzaroff.com |
Advanced Innovative Partners, Inc:
By: /s/ Roseanne Satz
Roseanne Satz, CEO
Responsible Person: Roseanne Satz
Address: 9429 Harding Ave. #148, Surfside, 33154, FL,
USA
Email: rose.satz@advacedinnovativepartners.com |
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APPENDIX A: GTC Products
Globestar is planning a specific formulation
of the three drugs listed below:
Minocycline
An oral tetracycline antibiotic. Used to treat
bacterial infections including respiratory and urinary tract infections. The drug is currently being studied for relapsing-remitting multiple
sclerosis (RRMS) or clinically isolated syndrome (CIS), referring to the first episode of neurologic symptoms that last at least 24-hours
and are caused by myelin damage.
Fluconazole
A triazole antifungal. Used to prevent and treat
a variety of fungal and yeast infections by stopping the growth of certain types of fungus. Studies using a combination of Minocycline
& Fluconazole against candida albicans fungal growths proven effective, in vitro.
Atorvastatin
A Statin, HMG CoA reductase inhibitor. Commonly
used to lower blood levels of LDL cholesterol, increase levels of HDL cholesterol and to lower triglycerides. It is also an effective
immunomodulatory agent shown to prevent autoimmune encephalomyelitis in animal model studies.
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APPENDIX B: SMIHC Territory
Countries that presently are not members of the African Union: |
Currently Members of the African Union: |
1 India
2 Bahrain
3 Bangladesh
4 Bhutan
5 Brunei
6 Indonesia
7 Jordan
8 Kuwait
9 Lebanon
10 Malaysia
11 Mauritius
12 Nepal
13 Oman
14 Pakistan
15 Philippines
16 Qatar
17 Saudi Arabia
18 Singapore
19 Sri Lanka
20 Thailand
21 Turkey
22 United Arab Emirates
23 Vietnam |
1 Burkina Faso
2 Federal Republic
of Nigeria
3 Kingdom of Eswatini
4 Kingdom of Lesotho
5 Republic of Angola
6 Republic of Benin
7 Republic of Botswana
8 Republic of Cabo
Verde
9 Republic of Côte
d’Ivoire
10 Republic of Ghana
11 Republic of Guinea
12 Republic of Guinea-Bissau
13 Republic of Liberia
14 Republic of Malawi
15 Republic of Mali
16 Republic of Mozambique
17 Republic of Namibia
18 Republic of Niger
19 Republic of Senegal
20 Republic of Sierra Leone
21 Republic of South Africa
22 Republic of the Gambia
23 Republic of Zambia
24 Republic of Zimbabwe
25 Togolese Republic
26 Arab Republic of Egypt
27 Central African Republic
28 Democratic Republic of Congo
29 Democratic Republic of São
Tomé and Príncipe
30 Federal Democratic Republic
of Ethiopia
31 Federal Republic of Somalia
32 Gabonese Republic
33 Islamic Republic of Mauritania
34 Kingdom of Morocco |
35 Libya
36 People’s Democratic
Republic of Algeria
37 Republic of Burundi
38 Republic of Cameroon
39 Republic of Chad
40 Republic of Djibouti
41 Republic of Equatorial Guinea
42 Republic of Kenya
43 Republic of Madagascar
44 Republic of Mauritius
45 Republic of Rwanda
46 Republic of Seychelles
47 Republic of South Sudan
48 Republic of the Congo
49 Republic of the Sudan
50 Republic of Tunisia
51 Republic of Uganda
52 Sahrawi Arab Democratic Republic
53 State of Eritrea
54 Union of the Comoros
55 United Republic of Tanzania |
# # #
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Exhibit 99.2
Collaboration Agreement
This Collaboration Agreement (“Agreement”)
dated September 26, 2023, is entered into by and between:
|
(1) |
GlobeStar Therapeutics Corporation, a Wyoming corporation (“GlobeStar”), 719 Jadwin Ave, Richland, Washington 99352, email: jim@katzaroff.com, and its wholly-owned subsidiary, SomaCeuticals, Inc., a Texas corporation, (“Soma”), 2500 Wilcrest Drive, Suite 300, Houston, Texas 77042, email: jim@katzaroff.com. GlobeStar and Soma are collectively referred to as “GTC”; on the one hand, and |
|
|
|
|
(2) |
SMI HealthCare LLC, a Wyoming limited liability company (“SMIHC”), 9663 Santa Monica Blvd., Suite 1048, Beverly Hills, CA 90210, email: ____________, and its affiliate in formation in India (herein, “IndiaCo”), email: _____________. SMIHC, IndiaCo and their respective direct or indirect subsidiaries are collectively referred to as “SMIG,” on the other. |
Each of GTC and SMIG is sometimes referred to herein
as a “Party” and collectively as the “Parties.”
Whereas Fabrizio de Silvestri,
of Terni, Italy has been engaged in clinical research to develop a method of treating neurodegeneration, by administering a synergistically
effective amount of the composition to an individual suffering from Multiple Sclerosis , to stabilize the progress of the MS and improve
the quality of life for this patient population;
Whereas Multiple Sclerosis
(“MS”) is a chronic disease in which the immune system of the individual attacks the central nervous system and affects
nerve cells;
Whereas the research of
Fabrizio de Silvestri has resulted in patents and patent applications that cover treatments of MS;
Whereas 7 to Stand, Corp.,
a Delaware corporation, having its principal office at P.O. Box 273, Bronxville, New York 10708 (“Stand”), as the owner
of the foregoing patents and patent applications, entered into an exclusive Amended Exclusive License Agreement with Soma dated as of
August 23, 2020 (the “Soma License Agreement”) to provide an exclusive license to Soma for the Patent Rights;
Whereas GTC is a development
stage company that owns Soma and intends to use the Patent Rights licensed to Soma to develop and commercialize products to treat MS;
Whereas personnel of SMIG
have expertise in health care, including experience with Regulatory Authorities in India, including for arranging for trials in India,
and arranging for sales and marketing of health care products and services in India and other developing nations;
Whereas SMIHC will hereafter
form a separate company, IndiaCo, to provide services hereunder and potentially a range of services to the health care industry in India
and developing nations;
Whereas GTC is seeking funding
for its responsibilities pursuant to this Agreement;
Whereas subject to the
terms and conditions of this Agreement and the limitations and restrictions set forth herein, the purposes of the Parties’ collaboration
hereunder are primarily that: (i) IndiaCo will assist GTC with respect to a range of services that are intended to support GTC’s
regulatory process, including endeavoring to arrange and monitoring the Initial Clinical Trial; (ii) if mutually agreed by the Parties,
IndiaCo will endeavor to arrange manufacturing of GTC Products in the Territory; (iii) IndiaCo will endeavor to distribute, sell and arrange
distribution for GTC Products in the Territory and to the NGO Group; (iv) IndiaCo may elect to manufacture, distribute and sell IndiaCo
Products in the Territory and to the NGO Group; and (v) IndiaCo will endeavor to otherwise license and exploit GTC-IP and IndiaCo-IP in
the Territory and to the NGO Group.
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Whereas GTC acknowledges
that any Clinical Study in India must comply with all applicable Rules, including that for a non-India company an Indian authorized agent
or a subsidiary of the foreign company that complies with all applicable Rules must undertake the Clinical Study, the Clinical Study will
have to align with Guidelines for International Collaboration/Research Projects in Health Research and must be submitted to the Indian
Council for Medical Research (“ICMR”) for approval of the Government of India through the Health Ministry Screen Committee
(“HMSC”), all of which requires knowledgeable advisors and an experienced, capable Indian law firm.
Whereas GTC intends that
the Initial Clinical Trial will be designed for the purpose of obtaining regulatory approval to manufacture, sell and distribute GTC Products
in India, and potentially other countries of the Territory, and that one or more subsequent Clinical Trials will be designed for the purpose
of obtaining regulatory approval to sell and distribute GTC Products in the United States and/or elsewhere. The Parties acknowledge that
except for the Initial Clinical Trial, other Clinical Trials might be undertaken by GTC outside of the Territory and, therefore, without
SMIG’s involvement pursuant to this Agreement.
Whereas references herein
to actions to be taken by GTC or a GTC designee, or payments due to GTC or a GTC designee, are references to actions to be taken by a
company designated from time-to-time by GlobeStar, and payments to be made to or by a company and to or from an account(s) designated
from time- to-time by GlobeStar.
Whereas references herein
to actions to be taken by SMIG, SMIHC or an SMIHC designee, or payments due to SMIG or SMIHC or an SMIHC designee, are references to actions
to be taken by a company designated from time-to-time by SMIHC, and payments to be made to or by a company and to or from an account(s)
designated from time-to-time by SMIHC. SMIHC may delegate such authority to IndiaCo.
Whereas references herein
to actions to be taken by IndiaCo or an IndiaCo designee, or payments due to IndiaCo, are references to actions to be taken by a company
designated from time-to-time by SMIHC, and payments to be made to or by a company and to or from an account(s) designated from time-to-time
by SMIHC. SMIHC may delegate such authority to IndiaCo.
Now, Therefore, the Parties
hereby agree on the foregoing recitals and further agree as follows:
I. Definitions
and Licenses
1. Certain
Definitions:
“Adjusted Deductible
Costs” means Deductible Costs, excluding the purchase price for GTC Products paid to GTC.
“Additional Services”
is defined in Section 5.2.
“Change Order”
means any amendment or addendum to a Work Order executed by the Parties.
“Clinical Trial”
means an interventional clinical study of the efficacy and risks of one or more GTC Products undertaken in the Territory with the goal
of assessing its effects on human health in accordance with the New Drugs and Clinical Trial Rules of 2019. There may be more than one
Clinical Trial. The term “Clinical Trial” does not include the regulatory filings or Intellectual Property Rights filings
required to permit a Clinical Trial to occur, or that may utilize results of the Clinical Trial to obtain approvals to manufacture, license,
sell or distribute GTC Products.
“Data” means
any and all information Processed by a Party under this Agreement that relates to personal information of an identifiable individual,
such as first and last name, tax number, other government- issued identifiers, date of birth, e-mail address, IP address, credit card
number, financial account number, and health information or medical records.
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“Deductible Costs”
means as to GTC Products and IndiaCo Products, as applicable: (i) cost of goods sold, including (a) for GTC Products sold to SMIG, the
price paid by SMIG to GTC for such GTC Products, and (b) for IndiaCo Products, the manufacturing costs thereof, (ii) royalties or participations
payable hereunder to the other Party for those products, (iii) marketing, advertising and sales costs for those products, and (iv) support
and warranty costs for those products.
“Deposit” is
a collective term that means the aggregate of the sums deposited in accordance with Section 16 in one or more accounts held by SMIG and/or
LocalCos (A) prior to each of the following: (i) commencement of a Work Order, (ii) formation of each LocalCo, (iii) each Clinical Trial,
(iv) each major manufacturing activity, and (v) each other major activity not otherwise included within another Deposit, and (B) deposited
in accordance with Section 16 to top up the amount remaining from the prior Deposit.
“Effective Date”
means the date on which the last to occur of the following occurs: (i) GlobeStar, Soma and SMIHC execute and exchange copies of this Agreement;
(ii) GlobeStar and Soma advise SMIHC by Notice that its board of directors has approved of the execution, delivery and performance of
this Agreement; and (iii) SMIHC advises GlobeStar and Soma by Notice that its manager has approved of the execution, delivery and performance
of this Agreement.
“Exchange Rate”
means the New York foreign exchange selling rate for the applicable local currency for trading among banks in amounts of $1,000,000 or
more, as quoted at 4:00 p.m. Eastern time on the last day of the calendar month preceding the applicable due date as reported in the Wall
Street Journal, or it ceases publishing such information, another major financial publication.
“FDA” means
the United States Food and Drug Administration.
“Force Majeure”
means any cause or event beyond the control of an affected Party such as fires, earthquakes, lightning, floods, explosions, storms, landslides
and other acts of natural calamity or acts of God; navigational accidents or maritime peril; vessel damage or loss; strikes, grievances,
actions by or among workers or lock-outs; accidents at, closing of, or restrictions upon the use of mooring facilities, docks, ports,
pipelines, harbors, railroads or other navigational or transportation mechanisms; disruption or breakdown of, explosions or accidents
to wells, storage plants, refineries, terminals, machinery or other facilities; acts of war, hostilities (whether declared or undeclared),
civil commotion, embargoes, blockades, terrorism, sabotage or acts of the public enemy; change in a law or regulation making a particular
action unlawful; interference, failure or cessation of supplies reasonably beyond the control of a Party, provided: (i) the Party takes
all reasonable actions to avoid or mitigate the event and its impact on that Party’s performance hereunder, and (ii) by the exercise
of due diligence, such Party could not have been able to avoid or overcome that event. Covid 19 or other health events are not a Force
Majeure; provided, however, that a lock down by Government order or similar order may be a Force Majeure depending upon the facts and
circumstances thereof.
“Formation Services”
means IndiaCo’s services to direct professionals in India to form India-LocalCo. “GTC-IP” means the Patent Rights
and any other Intellectual Property Rights licensed hereunder by GTC to SMIG.
“GTC Product”
means a product or service manufactured by or for GTC and made available under this Agreement for distribution or sale by IndiaCo in the
Territory and to the NGO Group, consisting of Licensed Products, Licensed Methods and potentially also other GTC products or services.
“GTC Use” means
the use of IndiaCo-IP by GTC in (i) developing, manufacturing and distributing Licensed Products and Licensed Methods, and (ii) regulatory
and Intellectual Property Rights filings and litigation pertaining thereto.
“IIP Period”
is defined in Section 18.1.
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“IndiaCo-IP”
means the results and proceeds of any services performed by IndiaCo pursuant to this Agreement, including the Intellectual Property Rights
therein.
“IndiaCo-IP-G”
means IndiaCo-IP when used for the GTC Use. “India-LocalCo” is defined in Section 6.2.
“IndiaCo Product”
means a Licensed Product or Licensed Method manufactured by or for IndiaCo. A GTC Product for which IndiaCo arranges manufacturing pursuant
to this Agreement is not an IndiaCo Product; rather, it is a GTC Product, even if GTC sells that GTC Product to IndiaCo for distribution
or sale pursuant to this Agreement. To the extent a product, service or method manufactured, distributed or sold by IndiaCo is not a Licensed
Product and does not otherwise utilize GTC-IP, that IndiaCo product, service or method is not an IndiaCo Product and is not subject to
this Agreement.
“IndiaCo Services”
means the services and deliverables undertaken pursuant to Work Orders, including Phase A Services and Phase B Services pertaining to
Clinical Trials, Regulatory matters, Intellectual Property Rights, and manufacturing, as described in Sections 6 through 10,, and Additional
Services, if any.
“Infringement”
is defined in Section 13.2.
“Initial Clinical Trial”
means a Clinical Trial in India pursuant to this Agreement intended to satisfy the requirements for all approvals necessary to manufacture,
license, sell and distribute the GTC Products included in that trial in India, and potentially other countries in the Territory. By U.S.
standards, this trial would generally include FDA Clinical Trial Phases 1 and 2, and possibly certain elements of FDA Clinical Trial Phase
3, and is unlikely to satisfy all FDA requirements for Clinical Trials for marketing authorization.
“Intellectual Property
Rights” means intellectual property rights recognized in any country or jurisdiction in the world, including, without limitation,
(i) patents, patent applications, patent disclosures, and rights of priority; (ii) trademarks, service marks, trade dress, trade names,
Internet domain names, slogans, logos, and corporate names, together with all the goodwill associated therewith, and registrations and
applications pertaining thereto; (iii) copyrights (registered or unregistered), moral rights, and copyrightable works and registrations
and applications for the registration thereof; (iv) computer software, data, databases, and documentation thereof; (v) trade secrets and
other confidential information including ideas, inventions (whether or not patentable and whether or not reduced to practice), know-how,
negative know-how, research information, drawings, specifications, designs, plans, proposals, financial and marketing plans, employee
information, customer and supplier lists, and related information and marketing materials; and (vi) other intellectual property rights.
“Licensed Method”
means any method or process on a country-by-country basis, the practice of which falls within the scope of a Valid Claim.
“Licensed Product”
means on a country-by-country basis, any product or service, the making, having made, using, selling, offering for sale, importing, exporting,
or performing in the country in question would (without the license granted in this Agreement) infringe directly, indirectly by inducement
of infringement, or indirectly by contributory infringement, at least one pending Valid Claim in that country. GTC Products may
include Licensed Products and products that are not Licensed Products. IndiaCo Products consist only of Licensed Products.
“LocalCo” is
defined in Section 6.1.
“Management Services
Agreement” is defined in Section 6.4.
“Net Recoveries”
means all non-refundable monetary awards actually received by SMIG pursuant to Section 13.4.1 for enforcing GTC-IP and IndiaCo-IP-G through
judgements or settlements of patent infringement suits, less two hundred percent (200%) of all litigation expenses, reasonable out-of-pocket
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expenses, reasonable costs, and other fees incurred
by SMIG, provided that the deduction shall be reduced to one hundred percent (100%) in the circumstances described in Section 13.4.1.
“Net Sales”
means the gross amount actually received by or on behalf of a Party or any Subsidiary thereof for sales, leases, licenses or other transfers
of Licensed Methods, GTC-IP, GTC Products, IndiaCo Products and IndiaCo-IP-G, as applicable, less the following deductions to the extent
applicable with respect to such sales, leases or other transfers and not previously deducted from the gross invoice price: (i) trade,
quantity or cash discounts and rebates to the extent actually allowed and taken; (ii) amounts repaid or credited by reason of rejection
or return of any previously sold, leased or otherwise transferred Licensed Methods, GTC-IP, GTC Products, IndiaCo Products and IndiaCo-IP-G,
as applicable; (iii) customer freight, transit, or insurance charges; and (iv) any sales, value added or similar taxes, custom duties
or other similar governmental charges, excluding taxes in the nature of income or profits taxes; provided that:
|
(A) |
Any sales, leases, licenses or other transfers of Licensed Methods, GTC-IP, GTC Products, IndiaCo Products and IndiaCo-IP-G, as applicable by each of SMIHC, IndiaCo, GlobeStar, Soma to or from a respective Subsidiary thereof that is not for the purpose of resale by such Subsidiary will be equal to the fair market value of the Licensed Methods, GTC-IP, GTC Products, IndiaCo Products and IndiaCo-IP-G so transferred, assuming an arm’s length transaction made in the ordinary course of business; and |
|
|
|
|
(B) |
Any sales, leases, licenses or other transfers of Licensed Methods, GTC-IP, GTC Products, IndiaCo Products and IndiaCo-IP-G, as applicable each of SMIHC, IndiaCo, GlobeStar, Soma to or from a respective Subsidiary thereof for resale, release, relicense or other transfer by such Subsidiary to a Third Person will be excluded from Net Sales. Instead, Net Sales will be determined based on sale, release, relicense or other transfer by the foregoing to a Third Person purchaser. |
“NGO Group”
means (i) the International Monetary Fund, World Bank, World Health Organization, United Nations and other multilateral and international
aid agencies and organizations, wherever located and wherever they may provide assistance; and (ii) Government relief and support agencies
with respect to their relief operations for countries other than Canada, the United States, United Kingdom, and members of the European
Union.
“Notice” is
defined in Section 33.8.
“Patent Rights”
means any and all rights of any kind or character recognized anywhere in the world arising from or related to: (i) the patents and patent
applications listed in Appendix A; (ii) any patent or patent application that claims priority to and is a divisional, continuation,
reissue, renewal, reexamination, substitution or extension of any patent application identified in (i); (iii) any patent or patent application
from which any patent application identified in (i) claims priority; (iv) any patents issuing on any patent application identified in
(i), (ii), or (iii), including any reissues, renewals, reexaminations, substitutions or extensions thereof; (v) any claim of a continuation-in-part
application or patent (including any reissues, renewals, reexaminations, substitutions or extensions thereof) that is entitled to the
priority date of, and is directed specifically to subject matter specifically described in, at least one of the patents or patent applications
identified in (i), (ii), (iii), or (iv); (vi) except as set forth herein with respect to the Territory, any foreign counterpart (including
PCTs) of any patent or patent application identified in (i), (ii), (iii), or (iv), or of the claims identified in (v); and (vi) any supplementary
protection certificates, pediatric exclusivity periods, any other patent term extensions and exclusivity periods and the like of any patents
and patent applications identified in (i) through (v).
Unless the context clearly indicates
otherwise, “Period” when used in reference to a portion of the Term refers only to the Services Period, Manufacturing
and Distribution Period, and License Period.
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“Person” means
any natural individual, legal person, firm, corporation, limited liability company, limited partnership, association, trust, charity,
government department, agency, unit or other entity, or any other group or entity.
“Phase A” means
that aspect of IndiaCo’s engagement described in Appendix 5.2.1.
“Phase A Services”
mean those IndiaCo Services to be undertaken for Phase A as described in Appendix 5.2.1.
“Phase B” means
that aspect of IndiaCo’s engagement described in Appendix 5.2.2.
“Phase B Services”
mean those IndiaCo Services to be undertaken for Phase B as described in Appendix 5.2.2.
“Process” or
“Processed” means obtaining, recording, holding or storing Data, or carrying out any operation or set of operations
on Data, including organizing, adapting, altering, retrieving, disclosing, transmitting, disseminating, making available, aligning, combining,
blocking, erasing, or destroying Data.
“Product Net Profits”
means as to any particular GTC Products and IndiaCo Products, as applicable and for the particular period for which an accounting pertains,
Net Sales thereof reduced by the Deductible Costs pertaining thereto.
“Regulatory Authority”
means any applicable government authority involved in granting approvals for the manufacturing, distribution, or marketing of a Licensed
Product or Licensed Method, including FDA, ICMR, HMSC, Central and State Drugs Standard Control Organization (“CDSCO”),
Drug Controller General of India (“DCGI”), India state licensing authorities, and equivalent regulators in other countries
of the Territory.
“Remaining Phase A Services”
means those Phase A Services other than the Formation Services.
“Rule” means
any applicable law, rule, regulation, court order, or other provision, order, decree, executive or judicial actions or pronouncements,
judgements, or the equivalent having the force of law.
“Sublicense”
means the grant, lease, license, sale, assignment or transfer by: (i) SMIHC, IndiaCo or a respective Subsidiary of either, authorizing
a Third Person to use or exploit any GTC-IP, or (ii) by GTC, or a Subsidiary thereof, authorizing a Third Person to use or exploit any
of the IndiaCo-IP.
Sublicensee” means
any Person granted a Sublicense.
“Subsidiary”
means a company that is directly or indirectly controlled and at least twenty-five percent (25%) directly or indirectly owned by the parent.
“Term” means
the period from the Effective Date until the termination or expiration of the last to terminate or expire of the Services Period, Manufacturing
and Distribution Period, and License Period, as defined below. The definition of “Term” does not include or refer to the IIP
Period, as defined below.
“Territory”
means the countries listed in Appendix B hereto, as the same may be modified from time- to-time by mutual agreement.
“Third Person”
means any Person other than SMIHC, IndiaCo, GlobeStar, Soma and their respective Subsidiaries.
“Valid Claim”
means a claim of an issued and unexpired patent within the Patent Rights that has not been (i) held permanently revoked, unenforceable,
unpatentable or invalid by a decision of a court or governmental body of competent jurisdiction, unappealable or unappealed within the
time allowed for appeal, (ii) rendered unenforceable through disclaimer or otherwise, (iii) abandoned, or (iv) permanently lost through
an interference or opposition proceeding without any right of appeal or review.
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“Work Order”
means Appendix 5.2.1, Appendix 5.2.2, each fully executed and delivered statement of work for Additional Services, and each
fully executed and delivered Change Order. Unless the Parties agree otherwise, each Work Order will include a description of services,
deliverables, timeline, compensation with respect thereto and such other matters as the Parties consider appropriate.
2. License
of GTC-IP to SMIG:
2.1. License
Grant. GTC hereby irrevocably grants to SMIG an exclusive license in the Territory and for the NGO Group in and to GTC-IP during the
License Period, including the rights to make, have made, use, offer to sell, sell, import, and export sublicenses, products and methods
and any other rights contained within GTC-IP in the Territory and for the NGO Group. Except as set forth herein or as required by law,
SMIG may distribute and sell IndiaCo Products, GTC Products and Licensed Methods only to purchasers located in the Territory or for use
in the Territory, or to and for the NGO Group. During the Term, GTC will not license or grant any other Person the right to sell products
or methods utilizing all or any GTC-IP in the Territory or to or for the NGO Group. The Parties acknowledge that a purchaser may transport
a product or method into or out of the Territory for its personal use and such activity is not a breach of this Agreement.
2.2. Subsidiaries
and Sublicensees. The license granted to SMIG under Section 2.1 includes the right to have some or all of SMIG’s rights or obligations
under this Agreement be exercised or performed by one or more of SMIHC’s Subsidiaries and/or Sublicensees, and/or IndiaCo’s
Subsidiaries and/or Sublicensees; provided, however, that any act or omission taken or made by a Subsidiary of SMIHC or IndiaCo under
this Agreement will be deemed an act or omission by SMIHC or IndiaCo, as applicable, under this Agreement.
2.3. No
Ownership Rights. Nothing in this Agreement will be construed to confer any ownership interest to SMIG in: (i) GTC-IP, (ii) other
patents obtained by GTC, or (iii) any other inventions or Intellectual Property Rights now or hereafter developed, owned, licensed or
acquired by GTC. Except as expressly set forth in this Agreement, as between the Parties, GTC owns all right, title, and interest in and
to GTC-IP and any other products or technology created or developed by GTC, whether pursuant to this Agreement, or otherwise and whether
created or developed by GTC or on its behalf.
2.4. GTC
Products. GTC represents and warrants that Appendix 2.4 set forth a list of current GTC Products, GTC Products under development
and additional information with respect thereto. On a quarterly basis, within thirty (30) days after each quarter, or more frequently
as events warrant, GTC will send Notices to SMIG updating Appendix 2.4. GTC will provide supplemental information requested by
SMIG to undertake its obligations pursuant to this Agreement. The Parties will consult regarding GTC’s product development efforts
so that SMIG is updated and so that IndiaCo may make recommendations pertaining to existing Work Orders and potential Work Orders.
2.5. SMIG
Exclusivity. During the License Period, and Manufacturing and Distribution Period, GTC will prohibit any of its sublicensees, distributors,
sales agents and customers from selling, leasing, licensing, shipping or otherwise making available GTC Products or GTC Methods in the
Territory, to or for the NGO Group. Without limitation, GTC shall insert provisions in each of its contracts, in form ad substance reasonably
acceptable to SMIHC, that prohibit counterparties, their licensees and affiliates from advertising, marketing, offering for sale, or delivering
GTC Products or GTC Methods in the Territory and to or for the NGO Group, and further prohibiting that portion of any website or similar
system operated by or for such Persons that includes the GTC Products or GTC Methods from being available in the Territory. GTC will enforce
such provisions and if it does not, SMIG will have the right to do so in GTC’s name. In the event any such Person violates such
provisions and sells or licenses any GTC Products or GTC Methods in the Territory or to or for the NGO Group, as minimum non-exclusive
damages, GTC shall pay to SMIHC the amount specified in Section 15.9 hereof.
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3. License
of IndiaCo-IP to GTC:
3.1. License
Grant. IndiaCo hereby irrevocably, except as set forth herein, grants to GlobeStar an exclusive license to use IndiaCo-IP-G outside
of the Territory during and after the Term. IndiaCo hereby grants to GlobeStar a non-exclusive license to use IndiaCo-IP-G after the Term
in the Territory. Each license includes the rights to make, have made, use, offer to sell, sell, import, and export sublicenses, products
and methods and any other rights contained within the IndiaCo-IP-G. During the Term, except as expressly permitted herein, GTC will not
use, license or grant to any Person the right to use IndiaCo-IP in the Territory. The Parties acknowledge that a Person who properly acquires
a product or method pursuant to this Section 3 may transport that product or method into or out of the Territory solely for that Person’s
personal use and such activity is not a breach of this Agreement.
3.2. Subsidiaries
and Sublicensees. The license granted to GlobeStar pursuant to Section 3.1 includes the right to have some or all of GTC’s rights
or obligations under this Agreement be exercised or performed by one or more of GlobeStar’s Subsidiaries and/or Sublicensees; provided,
however, that any act or omission taken or made by a Subsidiary of GlobeStar under this Agreement will be deemed an act or omission by
GTC under this Agreement.
3.3. No
Ownership Rights. Nothing in this Agreement will be construed to confer any ownership interest to GTC in: (i) IndiaCo-IP in the Territory
and IndiaCo-IP worldwide for uses other than GTC Uses, or (iii) any other inventions or Intellectual Property Rights now or hereafter
developed, owned, licensed or acquired by SMIG. Except as expressly set forth in this Agreement, as between the Parties, SMIG owns all
right, title, and interest in and to the IndiaCo-IP and any other products or technology created or developed by or for SMIG, whether
pursuant to this Agreement, or otherwise and whether created or developed by SMIG or on its behalf. SMIG further reserves the right to
license or otherwise use and license IndiaCo-IP inside the Territory for any purpose and outside of the Territory for purposes other than
the GTC Use.
3.4. IndiaCo
Products. On a quarterly basis, within ninety (90) days after each quarter, IndiaCo will send Notices to GTC providing updated information
on any IndiaCo Products being developed. The Parties will consult regarding IndiaCo’s product development efforts for IndiaCo Products
so that GTC is updated and so that the Parties may discuss their views with respect to such potential IndiaCo Products.
4. Sublicenses:
4.1. Sublicense
Grant. Each Party is entitled to grant Sublicenses to Third Persons under the licenses granted in Sections 2.1 and 3.1, respectively.
Any Sublicense shall be in writing and on terms and conditions in compliance with and consistent with this Agreement. Each Party shall
be liable to the other for damages arising from any provisions of any Sublicence agreements that violate this Agreement. On a calendar-
quarterly basis, within ninety (90) days after each quarter, each Party shall send the other Party a list of those Persons to whom a sublicense
was granted during that quarter, provided that a Party is not required to report the sublicense implicit in the sale of GTC Products or
IndiaCo Products for use by the purchaser thereof.
4.2. Breach
by Sublicensee. Each Party shall be responsible for any breach of a Sublicense agreement by any of its Sublicensees of which that
Party has actual knowledge and that results in a material breach of this Agreement. That Party shall either (i) cure such breach of this
Agreement, or (ii) enforce its rights by terminating such Sublicense agreement.
II. IndiaCo
Services
5. IndiaCo
Services Generally:
5.1. Engagement.
GlobeStar irrevocably, except as set forth herein, engages SMIG to provide the IndiaCo Services during the Services Period on the
terms and conditions described herein. As provided for in Work Orders, IndiaCo Services shall consist of services pertaining to Management
Services Agreements as
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described in Section 6, Clinical Trials as described
in Section 7, Regulatory Authorities as described in Section 8, Intellectual Property Rights as described in Section 9, and manufacturing
GTC Products as described in Section 10. IndiaCo’s engagement as a distributor and sales agent described in Section 11, the manufacturing,
distribution and sale of IndiaCo Products described in Section 12, and Intellectual Property Rights litigation described in Section 13,
are not IndiaCo Services and are not subject to Work Orders. SMIG is not being engaged to provide legal services, investment banking services,
accounting services, or tax advice. GTC acknowledges that GTC will be required to engage lawyers, accountants and tax experts to undertake
the business described in this Agreement, and may elect to engage investment bankers to assist it in seeking financing. Except as expressly
set forth in a Work Order, all terms of this Agreement also govern the Parties rights and obligations pursuant to Work Orders. IndiaCo
is not obligated to render any IndiaCo Services prior to GTC completing the related Deposit in accordance with Section 16. Nothing within
this Agreement shall be construed as SMIG providing GTC any legal advice or investment banking services.
5.2. Implementation
of Engagement. IndiaCo Services initially are allocated to Phase A Services and Phase B Services pursuant to the Work Orders in Appendices
5.2.1 and 5.2.2. The Parties may agree upon additional or supplemental IndiaCo Services (the “Additional Services”)
only pursuant to additional Work Orders, if any. Provided GTC timely performs its obligations under this Agreement:
5.2.1. The
Formation Services are part of Phase A. SMIG recommends to GTC that prior to commencement of Formation Services, GTC obtain tax advice
with respect thereto. After execution of this Agreement, at GTC’s election, the Formation Services shall commence prior to the Remaining
Phase A Services or concurrently with the Remaining Phase A Services. If GTC elects that the Formation Services commence prior to the
Remaining Phase A Services, then GTC shall so Notify SMIG and shall pay the FS Deposit. If any additional amounts are required for formation
or maintenance of India-LocalCo, GTC promptly will pay such amounts upon receipt of an invoice. Promptly after GTC confirms it has sufficient
financing to commence the Remaining Phase A Services and pays the Phase A Deposit as described in Section 16, IndiaCo shall commence commercially
reasonable efforts to undertake and complete the Remaining Phase A Services in accordance with this Agreement. If Formation Services did
not commence prior to the Remaining Phase A Services, then upon funding the Phase A Deposit, GTC also shall fund the FS Deposit and IndiaCo
shall undertake the Formation Services commencing at the commencement of the Remaining Phase A Services.
5.2.2. Promptly
after GTC confirms it has financing to commence the Phase B Services described in Appendix 5.2.2 and pays the Phase B Deposit as
described in Section 16, IndiaCo shall commence commercially reasonable efforts to undertake and complete the Phase B Services in accordance
with this Agreement. Unless the Parties agree otherwise in a Change Order, the Parties do not anticipate that Phase B Services will commence
prior to there being results of the Initial Clinical Trial sufficient, or anticipated to soon be sufficient, to obtain regulatory approvals
to manufacture, license, sell and distribute the GTC Products tested in that trial in India.
5.2.3. From
time-to-time IndiaCo and GTC may agree on further Work Orders for Additional Services. Upon execution and delivery by the Parties of a
Work Order, and GTC making the payments required in accordance with that Work Order, Section 15.7 and Section 16, IndiaCo shall commence
commercially reasonable efforts to undertake and complete such Additional Services in accordance with this Agreement.
5.3. Change
Orders. If in either Party's reasonable judgment there is a material change in the scope, duration, requirements, assumptions or dependencies
described in a Work Order, the Parties shall negotiate an appropriate Change Order with respect thereto. IndiaCo shall not be obligated
to undertake any change in its obligations pursuant to a Work Order unless reflected in a fully-executed Change Order. Unless the context
in this Agreement requires otherwise: (i) each reference herein to a Work Order means and includes Change Orders with respect thereto,
and (ii) each reference generally to Work Orders means and includes Change Orders.
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5.4. Reports.
At the request of either Party, IndiaCo and GTC will consult at least twice each month regarding the status and expectations for completion
of each Work Order. Provided GTC cooperates with IndiaCo and provides the information necessary or appropriate for IndiaCo to render the
reports described in Appendix 5.4 to GTC, during periods when such reports would be appropriate to the IndiaCo Services being rendered,
IndiaCo will issue such reports to GTC with the frequency set forth in Appendix 5.4.
5.5. Records.
IndiaCo will maintain appropriate books and records concerning its performance of IndiaCo Services under a Work Order for twenty-four
(24) months from the completion of such Work Order. GTC may review copies of such records at IndiaCo’s offices upon reasonable notice
and during IndiaCo’s normal business hours. For clarity, IndiaCo shall not be required to render any particular number of hours
of services, and SMIG does not maintain or provide time records or similar reports pertaining to its activities.
5.6. Cooperation.
To facilitate performance of IndiaCo Service, GTC will provide to SMIG such data, facilities, resources, documentation and other information
necessary or appropriate to support the performance of IndiaCo Services and undertake such other tasks and responsibilities as may be
set forth in the applicable Work Order (collectively, “GTC Responsibilities”). IndiaCo’s delay or nonperformance
of IndiaCo Services will be excused to the extent resulting from GTC’s delay or nonperformance of any GTC Responsibilities. IndiaCo
shall use commercially reasonable workaround efforts, provided that if IndiaCo’s workaround efforts would require additional IndiaCo
Services, IndiaCo shall notify GTC and IndiaCo’s obligation to perform workarounds will be subject to the Parties’ execution
of a Change Order. GTC shall be responsible for any costs arising therefrom as described in Section 15.7.
5.7. Acceptance.
Upon completion of each Work Order, GTC shall have ten (10) days in which to accept or reject such IndiaCo Services, unless the Work
Order provides a different acceptance period (in each case, the “Acceptance Period”). If prior to expiration of the
Acceptance Period GTC provides IndiaCo Notice specifying in reasonable detail the manner in which the IndiaCo deliverables do not substantially
conform to the requirements of the Work Order, then IndiaCo shall endeavor to remedy the deficiency. Acceptance irrevocably shall be deemed
to have occurred following expiration of the Acceptance Period absent a Notice of rejection delivered prior thereto.
5.7.1. IndiaCo
shall have sixty (60) days, or such other period provided in the Work Order to implement such changes as shall be reasonably required
to bring the deficient deliverables into substantial conformity with the requirements of the Work Order. In the event the corrected IndiaCo
Services do not substantially conform to the requirements of the Work Order after a second sixty (60) day period, GTC may, in its sole
discretion: (i) accept the non-conforming deliverables, (ii) negotiate a discount in related Management Fees for the non-conforming work;
(iii) require that IndiaCo make additional corrections to the deliverables according to a schedule mutually agreed upon by the Parties;
or (iv) terminate the applicable Work Order and receive a refund of all pre-paid amounts corresponding to the non-conforming deliverables.
5.7.2. For
clarity, where a deliverable is not within IndiaCo’s control (by way of illustration, the approval, clearance or issuance of a license
by a Regulatory Authority), the failure to obtain the desired result is not a non-conformity. By contrast, the failure to complete an
administrative filing likely would be a non-conformity, unless the failure is a result of Force Majeure, a breach of this Agreement by
GTC, or a failure of GTC to properly undertake the GTC Responsibilities. IndiaCo is not liable or responsible for delays in Clinical Trials,
or delays in the performance of counsel, accountants, experts, or manufacturers retained to assist in the activities described herein.
6. LocalCo;
Management Services Agreements.
6.1. Purpose
of LocalCos. As described in this Section 6, and consistent with advice provided by tax advisors and counsel, with the prior approval
of GTC, IndiaCo will manage professionals to form one or more companies organized under the laws of countries in the Territory in which
GTC intends to undertake business (each, a “LocalCo”). Except as the Parties mutually agree, during the Term, each
LocalCo will be a
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special purpose company that engages in no business
activities except to implement GTC’s rights and obligations pursuant to this Agreement. Except as the Parties mutually agree following
the receipt of advice from tax advisors and counsel, Intellectual Property Rights filings for the relevant country, filings with Regulatory
Authorities for the relevant country, contracts for Clinical Trials in the relevant country and contracts for manufacturing in the relevant
country will be entered into by the applicable LocalCo, provided that filings also will be made by IndiaCo and/or other SMIG companies
to reflect the licenses granted hereunder to SMIG, and SMIG’s other rights hereunder. As the counterparty to the foregoing filings
and contracts, the applicable LocalCo will be obligated to make any payments required thereunder, and will receive any payments arising
therefrom into a Two Signature Account (as defined below), provided that if the Third Person agrees to pay directly to SMIG any percentage
of such payments allocable to SMIG, LocalCo may receive GTC’s share of such payments in an account that permits withdrawals only
based on the signature of GTC’s designee.
6.2. India-LocalCo.
The formation of a LocalCo for India (“India-LocalCo”) is a Phase A Service. As described in Section 5.2.1, it
is intended that India-LocalCo will be formed promptly so that it may enter into agreements for the Clinical Trials and seek Indian regulatory
approvals. The India State in which GTC India- LocalCo is established and other matters pertaining to its organization will be mutually
agreed by SMIG and GTC. SMIG strongly advises GTC to seek advice from tax and corporate counsel regarding the ownership structure of India-LocalCo,
requirements for officers and directors, and the means by which ownership thereof, and/or net cash flow thereof to be paid over to GlobeStar.
If GTC declines to do so and nonetheless elects to proceed with Formation Services, then the Parties will mutually agree on ownership
structure, officers, directors and means of paying GlobeStar, it being understood that SMIG disclaims any liability for such decisions
and that GTC will fully indemnify SMIG for the decisions made with respect thereto as provided for in Section 31 hereof.
6.3. Formation
of other LocalCos. No LocalCos will be formed outside of India until legal advice is obtained regarding the ownership structure thereof,
requirements for officers and directors, and the means by which ownership thereof, and/or net cash flow thereof to be paid over to GlobeStar.
The formation of any other LocalCos in the Territory will procced, if at all, during Phase B as a Phase B Service. Formation of each LocalCo
will proceed after GTC pays the Deposit for its formation, maintenance and related Management Fees in accordance with Section 16.
6.4. Management
Services Agreements. Upon formation, each LocalCo will enter into an exclusive management services agreement (each, a “Management
Services Agreement”) with IndiaCo or an affiliate thereof designated by SMIHC, pursuant to which an SMIHC designee will manage
the LocalCo during the remainder of the Services Period to implement the terms of this Agreement. Except to the extent local counsel or
tax advisors advise otherwise, each Management Services Agreement shall be consistent with, and governed by this Agreement, and shall
further provide:
6.4.1. For
establishing bank accounts with signature authority such that: (i) SMIHC’s designee’s signature will be sufficient to release
and pay funds consistent with Section 16, (i) joint signatures of a GTC designee and an IndiaCo designee will be required to allocate,
release and pay funds arising from computations made for payments pursuant to Section 14 or any other amounts received by that LocalCo
that includes a portion payable to SMIG, unless GTC determines that the signature of an IndiaCo designee alone will be sufficient (such
account is herein referred to as a “Two Signature Account,” whether it requires two signatures or only the signature
of an IndiaCo designee), and (iii) GTC’s designee’s signature alone shall be sufficient to release any other funds belonging
to GTC. Where available, the India branches or associates of U.S. banks will be used for LocalCo bank accounts. Either Party may determine
that references in this Section 6.4.2 to its designee shall require signatures of two of its designees.
6.4.2. GTC
shall cause each LocalCo to include provisions in all filings and contracts it enters into during the Term related to GTC-IP, GTC Products,
IndiaCo-IP, IndiaCo Products, or any activity which is a subject of this Agreement, that require (i) concurrent notices be given to SMIG
and its counsel, (ii) payments
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to the Two Signature Account, or otherwise to allocate
payments such that any portion thereof payable to SMIG be paid directly to the account designated by SMIG; (ii) access to SMIG during
the Term to the books, records, personnel and business activities of the counterparty at least comparable to that granted to the LocalCo
and GTC; (iii) an exculpation clause in form and substance reasonably acceptable to SMIHC by which the counterparty acknowledges that
SMIG is not liable for the representations, warranties, covenants, agreements, obligations and debts of the LocalCo; and (iv) with respect
to Clinical Trials, manufacturing, and any other contract that implements this Agreement, requires the counterparty to accept instructions
from SMIG on behalf of GTC.
6.4.3. GTC
shall cause its designees to execute filings and contracts entered into by each LocalCo, provided that following receipt of advice from
tax advisors and counsel, SMIG may recommend that certain contracts or filings be executed on behalf of one or more LocalCos by designees
of SMIHC. In such event, GTC shall consider SMIG’s recommendation and shall not unreasonably withhold consent thereto.
6.4.4. Except
as mutually agreed by the Parties, each Management Services Agreement will include Sections 17 to 33 of this Agreement, excluding Section
20 and inapplicable provisions of Section 18.
6.4.5. Each
LocalCo will unconditionally, jointly and severally, guarantee GTC’s representations, warranties, covenants and obligations pursuant
to this Agreement. SMIG will not be obligated to enforce the guarantee as a condition of pursuing its rights against GTC or any other
LocalCo and may elect whether and when to do so from time-to-time.
6.4.6. IndiaCo
will not have any liability for the representations, warranties, covenants, agreements, obligations and debts of the LocalCo.
6.5. Tax
Structure. Notwithstanding anything to the contrary in this Section 6, when GTC is capable of paying professional tax advisors to
review GTC’s tax structure, including as provided for in this Agreement: (i) pursuant to a mutually agreed Work Order, SMIG will
render Additional Services to participate in that review, and (ii) the Parties may modify the structure described in this Section 6 as
they mutually agree, provided that if any such revised structure could or might impair, encumber, or diminish any of SMIG’s rights,
financial participations or perquisites pursuant to this Agreement, the Parties shall in good faith make adjustments that indemnify SMIG
for the foregoing.
6.6. Management
Fees. SMIG’s Management Fee for forming and rendering management services for India-LocalCo is included in the Management Fees
for Phase A Services and Phase B Services. For each additional LocalCo, SMIHC’s designee will be entitled to an additional Management
Fee as provided for in Sections 15.3 and 15.7. In each instance, SMIG shall be reimbursed all of its related costs and expenses, promptly
after providing an invoice with respect thereto. GTC acknowledges that SMIG will require additional staff as the number of LocalCos increases,
and that SMIG and each LocalCo, will be required to engage local individuals and professional firms. The cost of the foregoing will be
funded by GTC.
7. Clinical
Trials:
7.1. Generally.
The Parties will consult regarding all matters pertaining to Clinical Trials, including the number, purpose, scope, design, potential
partners, potential participants, location, budget and timing. As between the Parties, GTC shall have final approval on the foregoing,
provided that it shall not exercise its approvals inconsistent with this Agreement or applicable Rules. As between the Parties, GTC is
solely responsible for all fees, costs and expenses for, relating to, and arising from each such Clinical Trial. The Parties acknowledge
that such trials may be very expensive; may not occur as initially contemplated; may not obtain clinically significant results or results
otherwise satisfactory to Regulatory Authorities; and may not obtain the results expected at the time such trials are undertaken.
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7.2. Selecting
Medical Institutions. IndiaCo shall recommend to GTC one or more medical institutions, medical professions, or other facilities (collectively,
herein referred to as “Medical Institutions”) that might participate in, facilitate, or undertake, all or a portion
of the Clinical Trials for GTC Products. With assistance of qualified India counsel, experts, and GTC, following GTC’s approval
as to the Medical Institution or institutions that might participate in or undertake each Clinical Trial, IndiaCo will endeavor to negotiate
the terms on which each such Medical Institution participates in or undertakes the applicable Clinical Trial or Trials. GTC shall have
the right to approve of the terms thereof, such approval not to be unreasonably withheld, delayed or conditioned.
7.3. Design.
With respect to each Clinical Trial, GTC, the Medical Institutions selected to participate in or undertake that Clinical Trial, and
outside experts selected by GTC and SMIG will collaborate in the requirements, scope, design and budget of each Clinical Trial. As between
the Parties, GTC shall have final approval on the foregoing, provided that it shall not exercise its approvals inconsistent with this
Agreement or applicable Rules. It is anticipated that representatives of GTC likely will be required to visit India and to participate
in the process of soliciting and negotiating arrangements with Medical Institutions for Clinical Trials. It also is anticipated that GTC
will work directly with Medical Institutions during Clinical Trials.
7.4. Arrangements.
It is anticipated that Medical Institutions participating in or undertaking a Clinical Trial might: (i) finance or arrange for the
financing of all or a portion of the cost of the Clinical Trial and/or might provide contributions in kind with respect thereto; and/or
(ii) seek certain rights in the GTC-IP, GTC Products, IndiaCo-IP, and/or IndiaCo Products, and/or (iii) seek financial payments, royalties
or other financial participations in all or any of GTC, SMIG, GTC-IP, GTC Products, IndiaCo-IP, and/or IndiaCo Products. The Parties acknowledge
that as between SMIG and GTC, GTC is responsible for all fees, costs and expenses of the Clinical Trial and the negotiation of all agreements
pertaining thereto. In no event shall any rights, participations or encumbrances of any nature be granted to such Medical Institutions
or otherwise in: (x) SMIG, IndiaCo-IP or IndiaCo Products without the express prior approval of SMIHC in its sole and unfettered discretion
pursuant to a document executed by the CEO of SMIHC; (y) GTC, GTC-IP or GTC Products without the express prior approval of GTC in its
sole and unfettered discretion pursuant to a document executed by the CEO of GlobeStar; or (z) GTC, GTC-IP or GTC Products that could
or might impair, encumber, or diminish any of SMIG’s rights, financial participations or perquisites pursuant to this Agreement
without the express prior approval of SMIHC in its sole and unfettered discretion pursuant to a document executed by the CEO of SMIHC.
Any purported grant of rights contrary to the foregoing is void ab initio.
7.5. Costs.
GTC acknowledges that the costs of a Clinical Trial and the fees and costs of counsel, experts and other Persons who participate in
selecting and contracting with Medical Institutions for Clinical Trials, and for undertaking Clinical Trials may be considerable individually,
and in the aggregate. There can be no assurance that any Medical Institution will agree to undertake a Clinical Trial, or that any Medical
Institution will agree to fund all or any portion of the costs of a Clinical Trial. No Clinical Trial will proceed until after GTC pays
the Deposit related thereto in accordance with Section 16.
7.6. Limitation
of IndiaCo’s Services. It is anticipated that agreements pertaining to the participation of Medical Institution(s) in Clinical
Trial(s) in the Territory will be entered into by a LocalCo, and that LocalCo will pay any portion of the costs thereof for which GTC
is responsible. IndiaCo will act as a liaison for GTC with respect to the Medical Institution(s) participating in, or undertaking, a Clinical
Trial, but IndiaCo generally will not direct the Clinical Trial. IndiaCo has no liability for, related to, or arising out of Clinical
Trials. No Party makes any representations with respect to the findings of any Clinical Trial.
7.7. Initial
Clinical Trial. Phase A Services include seeking to arrange for the Initial Clinical Trial, and thereafter monitoring that trial and
based on its results, seeking regulatory approval for the manufacturing, license, sale and distribution of the GTC Products tested in
the Initial Clinical Trial in India. Any other Clinical Trials in the Territory, including any Clinical Trial intended to satisfy U.S.
regulatory requirements and/or other
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regulatory activities will be undertaken exclusively
by SMIG pursuant to this Agreement either during Phase B, or pursuant to a separate Work Order for Additional Services, as appropriate.
7.8. Cooperation.
The Parties shall promptly cooperate with respect to IndiaCo’s services described in this Section 7 by providing data and information
to each other, as reasonably requested. For clarity, as between the Parties, GTC shall be solely responsible for funding all Clinical
Trials undertaken by the with respect to GTC-IP, IndiaCo-IP, GTC Products and IndiaCo Products, whether included in an approved budget,
or otherwise, provided that GTC shall not be responsible for funding any Clinical Trial undertaken by IndiaCo that has not been approved
by GTC. If requested to do so by GTC, during the Services Period, IndiaCo will cooperate with other advisors to GTC with respect to the
selection of Medical Institutions for Clinical Trials in the Territory, the design of such Clinical Trials, the terms on which Medical
Institutions undertake such Clinical Trials, and other matters, provided that: (i) IndiaCo is the lead advisor, and (ii) there is complete
transparency with respect to the involvement of the other advisors, including the concurrent disclosure to GTC of any material information
or instructions communicated between GTC and any such advisor.
7.9. Recoupment.
None of GTC, the Medical Institutions, or Third Persons shall have recoupment rights or any other rights or perquisites with respect
to their investments in Clinical Trials that impair, encumber or otherwise affect SMIG’s rights pursuant to this Agreement. Any
purported grant of rights contrary to the foregoing is void ab initio.
7.10. Notifications.
Each Party shall promptly Notify the other of any material information pertinent to IndiaCo’s ability to undertake its services
pursuant to this Section 6.
7.11. Management
Fees. For its services pursuant to this Section 7, SMIG will be paid the Management Fees described in Sections 15.1, 15.2, 15.4 and
15.7, and shall be reimbursed all of its related costs and expenses.
8. Regulatory
Matters:
8.1. Regulatory
Matters Outside of Territory. As between the Parties, GTC is responsible, at its cost, for all regulatory matters outside of the Territory,
including all licenses, clearances, approval, permissions and permits related to GTC-IP, IndiaCo-IP-G and GTC Products. To the extent
provided for in a Work Order, IndiaCo shall undertake IndiaCo Services in support thereof. IndiaCo hereby licenses to GTC the right to
use the results and proceeds of IndiaCo’s contributions to GTC’s regulatory filings and materials outside the Territory without
compensation other than as set forth herein. As between the Parties, GTC shall solely own all right, title and interest in and to all
regulatory approvals and filings received or made by GTC outside of the Territory pertaining to GTC-IP.
8.2. Regulatory
Matters in Territory. IndiaCo shall recommend to GTC decisions and actions regarding regulatory matters in the Territory relating
to or involving GTC-IP, GTC Products, IndiaCo-IP-G, and IndiaCo Products before all Regulatory Authorities in the Territory, including
the ICMR, HMSC, CDSCO, DCGI and India state licensing authorities. Provided GTC timely performs its obligations under this Agreement and
is not in breach hereof and engages and timely pays experienced regulatory law firms and other experts selected or approved of by IndiaCo,
IndiaCo shall, pursuant to Work Orders and at GTC’s cost and expense with respect to any such regulatory matters in the Territory:
(i) act as business liaison with the ICMR, HMSC, CDSCO, DCGI, state licensing authorities and other Regulatory Authorities in the Territory
for all necessary regulatory matters pertaining to each Clinical Trial and the sale and distribution of GTC Products and IndiaCo Products
in the Territory; (ii) supervise and direct such counsel and others to prepare and make all submissions regarding the regulatory matters
and to maintain continuing communications with such Regulatory Authorities; (iii) monitor all studies pertinent to the regulatory matters;
and (iv) endeavor, with the cooperation and contributions of GTC, such counsel and experts, to obtain regulatory approvals, as reasonably
deemed necessary by IndiaCo. GTC hereby licenses to SMIG the right to use GTC’s contributions to IndiaCo’s regulatory filings
and materials in the Territory without compensation other than as set forth herein. IndiaCo may
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condition its services related to regulatory activities
on the pre-funding by GTC of budgeted fees, costs and expenses related thereto. For clarity, a substantial portion of the efforts required
to obtain regulatory approvals will be undertaken by counsel and other experts. Outside of India, there will be additional and different
Regulatory Authorities and additional counsel and experts likely will be required at potentially substantial cost to GTC.
8.3. Cooperation.
The Parties shall cooperate with respect to such regulatory matters by providing data and information to each other, as reasonably
requested. For clarity, as between the Parties, GTC shall be solely responsible for funding all regulatory matters undertaken by the Parties
worldwide with respect to GTC- IP and IndiaCo-IP, other than IndiaCo-IP expressly for a use other than the GTC Use, whether included in
an approved budget, or otherwise, provided that GTC shall not be responsible for funding any regulatory activities undertaken by IndiaCo
in a country of the Territory which has not been approved by GTC, or for regulatory activities undertaken by IndiaCo in an approved country
where such activities were not approved by GTC, provided further that GTC shall be responsible for the costs of all regulatory activities
in a country approved by GTC if such activities are required by a regulatory official or applicable Rule, or reasonably necessary for
SMIG to avoid liability, regardless of whether specifically approved of by GTC.
8.4. Recoupment.
As between the Parties, neither GTC nor any Third Person shall have recoupment rights or other rights or perquisites as to its investments
made with respect to regulatory matters that impairs, encumbers or otherwise affects SMIG’s rights or perquisites pursuant to this
Agreement. Any purported grant of rights contrary to the foregoing is void ab initio.
8.5. Notifications.
Each Party shall Notify the other of any technical or clinical advances, useful modifications, side effects, or new government regulations
relating to the Licensed Products or Licensed Methods that come to its knowledge; and all actions and communications (even if believed
to be without foundation) by or threatened by a Regulatory Authority or other government authority relating to any Licensed Products or
Licensed Methods.
8.6. Management
Fees. For its services pursuant to this Section 8, SMIG will be paid the Management Fees described in Sections 15.1, 15.2, and 15.7,
and shall be reimbursed all of its related costs and expenses
9. Certain
Intellectual Property Rights Matters:
9.1. Responsibility
Outside of Territory. As between the Parties, GTC is responsible at its cost for all matters pertaining to the preparation, filing,
prosecution, protection, defense and maintenance of Patent Rights and other Intellectual Property Rights in GTC-IP and IndiaCo-IP-G, including
patents, copyrights and trademarks outside of the Territory. To the extent provided for in a Work Order, IndiaCo shall undertake IndiaCo
Services in support thereof. IndiaCo hereby licenses to GlobeStar the right to use IndiaCo’s contributions to GTC’s patent,
trademark, and copyright filings and materials outside the Territory without compensation other than as set forth herein. As between the
Parties, GTC shall solely own all right, title and interest in and to all patent, trademark, and copyright filings received or made by
GTC outside of the Territory pertaining to GTC-IP.
9.2. Responsibility
in Territory. IndiaCo shall recommend to GTC decisions and actions regarding the preparation, filing, prosecution, protection, defense
and maintenance in the Territory of all Patent Rights and other Intellectual Property Rights in GTC-IP and IndiaCo-IP-G, including patents,
copyrights and trademarks. Provided GTC timely performs its obligations under this Agreement and is not in breach hereof and engages and
timely pays an experienced Intellectual Property Rights law firm and other experts selected or approved of by IndiaCo, IndiaCo shall,
pursuant to Work Orders and at GTC’s cost and expense with respect to any such Intellectual Property Rights matters pertaining to
GTC-IP and IndiaCo-IP-G: (i) act as business liaison with the appropriate Government Authorities in the Territory with respect thereto;
(ii) select and supervise counsel and others to prepare and make all submissions regarding such matters; and (iii) endeavor
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to obtain patents, copyright registrations and trademarks,
as reasonably deemed necessary by IndiaCo. IndiaCo further has the right, but not the obligation, at GTC’s cost and expense, to
prepare, file, prosecute, protect, defend and maintain such rights in the Territory. GTC hereby licenses to SMIG the right to use GTC’s
contributions to IndiaCo’s filings and materials inside of the Territory without compensation other than as set forth herein. As
between the Parties, GTC shall own all right, title and interest in and to all patents, trademarks and copyrights received during the
Term in the Territory that arise from GTC Patent Rights. IndiaCo may condition its services related to Intellectual Property Rights on
the pre-funding by GTC of budgeted fees, costs and expenses related thereto. As between the Parties, SMIG is responsible for all matters
pertaining to Intellectual Property Rights pertaining to uses of IndiaCo-IP other than for the GTC Use.
9.3. Cooperation.
With respect to IndiaCo Services pertaining to Intellectual Property Rights in the Territory:
9.3.1. GTC
shall fully cooperate with requests from SMIG for assistance to exploit SMIG’s rights under this Agreement. GTC shall make all reasonable
attempts to have the inventors of the Patent Rights cooperate with SMIG to further the goals of this Agreement. Further, GTC agrees to
execute all papers and to perform such other proper acts as SMIG may deem necessary pertaining to SMIG’s rights in this Agreement.
Specifically, GTC shall execute, or have executed where required, documents substantially in the form of Appendix 9.3.1A, Patent
Assignment and Appendix 9.3.1B, Confirmatory Grant of Exclusive License. GTC also grants SMIG the right to file and record such
documents at the patent and trademark offices, and any other government agency, in any country in the Territory, as determined by IndiaCo.
Nothing within this Agreement shall be construed as SMIG providing GTC any legal advice.
9.3.2. GTC
shall: (i) instruct any patent counsel to furnish SMIG with copies of all correspondence relating to the Patent Rights from the United
States Patent and Trademark Office (USPTO) and any other patent office, as well as copies of all proposed responses to such correspondence
in time for IndiaCo to respond to any actions; (ii) provide SMIG with cooperation and any necessary documents to file any patent applications;
(iii) consult with SMIG with respect to patent filing strategies; (iv) supply SMIG with a copy of all previously filed patent applications,
as filed, together with Notice of their respective filing dates and serial numbers; and (v) keep SMIG advised of the status of actual
and prospective patent filings in the field of MS, including immediately forwarding to SMIG any correspondence received regarding the
Patent Rights. IndiaCo shall give GTC the opportunity to provide comments on and make requests of IndiaCo concerning the preparation,
filing, prosecution, protection, defense and maintenance of the Patent Rights and other Intellectual Property Rights in GTC-IP and IndiaCo-IP-G
in the Territory. Except where it would conflict with applicable Rule or the orders or practice of any Regulatory Authority, patent, trademark
or copyright office, or where it affects IndiaCo-IP for a use other than the GTC Use, as between SMIG and GTC, GTC will have the final
decision. SMIG shall have final approval to the extent appropriate or necessary to comply with applicable Rule or the orders or practice
of any Regulatory Authority, patent, trademark or copyright office, or where it affects IndiaCo-IP for a use other than the GTC Use.
9.3.3. IndiaCo
shall email to GlobeStar copies of all filings, and amendments thereto, any correspondence or notices from Government authorities pertaining
thereto.
9.4. Expenses.
During the Term, GTC shall be responsible for all expenses with respect to the preparation, filing, prosecution, protection, defense,
and maintenance of GTC-IP and Intellectual Property Rights in IndiaCo-IP-G. Should GTC choose not to seek any one or more patents included
in the Patent Rights in the Territory or pay any maintenance fees (or similar fees) for any one or more such patents in the Territory,
SMIG shall have the right to assume responsibility for the control and maintenance of such specific patent or patents in the Territory.
The SMIG company assuming such responsibility shall thereafter be responsible for all expenses associated with such specific patent or
patents and shall be entitled to commercialize such specific patent or patents in the Territory to any Third Person at its sole discretion,
to cease any payments to GTC with
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respect thereto and to retain for itself any revenues
derived therefrom. The foregoing shall not modify SMIG’s other rights in the Territory.
9.5. Abandonment.
In the event that neither SMIG nor GTC pays for prosecution, defense, or maintenance of any specific Patent Rights in the Territory,
on a patent-by-patent basis, any license granted by GTC to SMIG for those specific Patent Rights will terminate and GTC will have no rights
to receive any royalties that were due for such specific Patent Rights.
9.6. Marking.
Each Party shall, and shall cause its Subsidiaries and Sublicensees to, mark all Licensed Products and Licensed Methods sold, or otherwise
disposed of in such a manner, to conform with the patent laws and practice of the country to which such products are shipped or in which
such products are sold for purposes of identifying the Patent Rights when a Valid Claim exists in such country. The same process shall
be followed for any other patents included in GTC-IP or IndiaCo-IP-G.
9.7. Recoupment.
As between the Parties, neither GTC nor any Third Person shall have recoupment rights or other rights or perquisites as to its investments
made with respect to Intellectual Property Rights that impairs, encumbers or otherwise affects SMIG’s rights or perquisites pursuant
to this Agreement. Any purported grant of rights contrary to the foregoing is void ab initio.
9.8. Notifications.
Each Party shall Notify the other of any material information pertinent to IndiaCo’s ability to undertake its services pursuant
to this Section 9.
9.9. Management
Fees. For its services pursuant to this Section 9, SMIG will be paid the Management Fees described in Sections 15.1, 15.2, and 15.7,
and shall be reimbursed all of its related costs and expenses
10. Manufacturing:
As between the Parties, GTC is not required to manufacture or assemble GTC Products in the Territory. Notwithstanding the foregoing,
if by reason of applicable Rule, or otherwise, GTC elects to manufacture GTC Products in the Territory, during the Manufacturing and Distribution
Period, GTC will work exclusively with IndiaCo to arrange for such manufacturing and to supervise such manufacturing.
10.1. Generally.
The Parties will consult regarding all matters pertaining to manufacturing of GTC Products in the Territory. As between the Parties,
GTC shall have final approval as to the selection of manufacturer(s) for GTC Products and the terms of each manufacturing agreement, provided
that it shall not exercise its approvals inconsistent with this Agreement or applicable Rules. As between the Parties, GTC is solely responsible
for the fees, costs and expenses of each such manufacturer, including its raw materials, manufacturing process, inspections, warehousing,
shipping and fulfillment.
10.2. Selecting
a Manufacturer. If requested by GTC to do so, IndiaCo shall recommend to GTC one or more manufacturers that might participate in,
or undertake, all or a portion of the manufacturing in the Territory for GTC Products. With assistance of qualified India counsel, experts,
and GTC, following GTC’s approval as to the manufacturer or manufacturers that might participate in manufacturing GTC Products,
IndiaCo will endeavor to negotiate the terms on which each such manufacturer participates in manufacturing GTC Products. GTC shall have
the right to approve of the terms thereof, such approval not to be unreasonably withheld, delayed or conditioned. As specified in the
Phase A Services, IndiaCo will endeavor to identify a manufacturer for doses used in the Initial Clinical Trial.
10.3. Arrangements.
It is anticipated that manufacturers might: (i) finance or arrange for the financing of all or a portion of the cost of the manufacturing
and/or might provide contributions in kind with respect thereto; and/or (ii) seek certain rights in the GTC-IP, GTC Products, IndiaCo-IP,
and/or IndiaCo Products, and/or (iii) seek financial payments, royalties or other financial participations in all or any of GTC, SMIG,
GTC- IP, GTC Products, IndiaCo-IP, and/or IndiaCo Products. The Parties acknowledge that as between SMIG and GTC, GTC is responsible for
all fees, costs and expenses of manufacturing GTC Products and the negotiation of
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all agreements pertaining thereto. In no event shall
any rights, participations or encumbrances of any nature be granted to any manufacturers or otherwise in: (x) SMIG, IndiaCo-IP or IndiaCo
Products without the express prior approval of SMIHC in its sole and unfettered discretion pursuant to a document executed by the CEO
of SMIHC; (y) GTC, GTC-IP or GTC Products without the express prior approval of GTC in its sole and unfettered discretion pursuant to
a document executed by the CEO of GlobeStar; or (z) GTC, GTC-IP or GTC Products that could or might impair, encumber, or diminish any
of SMIG’s rights, financial participations or perquisites pursuant to this Agreement without the express prior approval of SMIHC
in its sole and unfettered discretion pursuant to a document executed by the CEO of SMIHC. Any purported grant of rights is void ab
initio. Any purported grant of rights contrary to the foregoing is void ab initio.
10.4. Cooperation.
The Parties shall cooperate with respect to IndiaCo’s services described in this Section 10 by providing data and information
to each other, as reasonably requested. For clarity, as between the Parties, GTC shall be solely responsible for funding all manufacturing
with respect to GTC Products.
10.5. Recoupment.
None of GTC, the manufacturers, or Third Persons shall have recoupment rights or any other rights with respect to their investments
in manufacturing that impair, encumber or otherwise affect SMIG’s rights pursuant to this Agreement. Any purported grant of rights
contrary to the foregoing is void ab initio.
10.6. Notifications.
Each Party shall Notify the other of any material information pertinent to IndiaCo’s ability to undertake its services pursuant
to this Section 10.
10.7. Management
Fees. For its services pursuant to this Section 10, SMIG will be paid the Management Fees described in Sections 15.5 and 15.7, and
shall be reimbursed all of its related costs and expenses.
III. Other
Areas of Collaboration
11. Distribution
of GTC Products: During the Manufacturing and Distribution Period:
11.1. Engagement.
During the Manufacturing and Distribution Period, GTC hereby irrevocably engages and grants to SMIG the rights to be its exclusive
customer, distributor, sales agent and representative for GTC Products sold to Persons located in the Territory and to or for the NGO
Group, whether for use in the Territory or shipment by such Persons outside of the Territory, provided that SMIG may elect by Notice to
GlobeStar to forego rights during a specified period for specified products and regions and for those products and regions, GTC may engage
Third Persons. Except with SMIHC’s prior written consent, GTC will not sell or authorize the sale of GTC Products to any Person
located in the Territory or for resale to a Person located in the Territory, or to or for the NGO Group, except to SMIG or a Person authorized
in writing by SMIHC.
11.2. Customer
or Distributor. When SMIG is a customer or distributor:
11.2.1. The applicable
SMIG company shall purchase GTC Products from GTC for a mutually agreed price that supports (i) a Product Net Profits margin on SMIG’s
Net Sales, computed separately for each GTC Product, each country of the Territory, and for the NGO Group, of not less than forty percent
(40%) and (ii) a profits before tax margin computed separately for each GTC Product, each country of the Territory, and for the NGO Group,
of not less than fifteen percent (15%), provided that (iii) in no event shall the price paid by the SMIG company exceed the lowest price
paid by any other GTC customer or distributor, with appropriate discounts if the aggregate SMIG volume exceeds the volume of the distributor
or customer that otherwise has the lowest price. The applicable SMIG company will pay GTC for each GTC Product it purchases and does not
return within thirty (30) days after the end of each month in which IndiaCo receives Net Sales for that GTC Product from its sub-distributors
or customers, as applicable.
11.2.2. Prior
to the applicable SMIG company offering GTC Products for sale in any country, or from time-to-time thereafter, if SMIG elects to request
GTC to participate in funding its Adjusted Deductible
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Costs, SMIG shall deliver a Notice to GTC setting
forth a proposal. The Parties thereafter shall negotiate in good faith with respect to those GTC Products, the portion of the applicable
Adjusted Deductible Costs, the period, and the country to be funded by GTC. The applicable Product Net Profits from the distribution and
sale of the relevant GTC Products shall be allocated as set forth in Section 14.5. SMIG may require GTC to pre-fund its budgeted contribution
to Adjusted Deductible Costs.
11.2.3. The reference
to “lowest price” means the lowest price, net of all discounts, rebates, free goods or other adjustments during the period
commencing two (2) years before a sale to SMIG and ending two (2) years thereafter. If a GTC sale price to a third Person after a sale
hereunder to SMIG results in a retroactive adjustment of the sale price to SMIG, that retroactive adjustment will be applied as a credit
against subsequent purchase orders placed by SMIG. GTC shall provide to SMIG reasonably detailed information required to compute “lowest
price” on a quarterly basis, within ninety (90) days after each quarter.
11.3. Sale
Agent.
11.3.1. In addition
to SMIG’s rights pursuant to Section11.1, with GlobeStar’s prior consent by Notice, SMIG also may act as sales represent and/or
distributor for such other countries and Persons as SMIG may request from time-to-time.
11.3.2. When the
applicable SMIG company is a sales representative and agent: (i) the price offered to SMIG’s customers will be the same price paid
by SMIG as a customer or distributor plus a mark-up of seventeen and one-half percent (17.5%), unless SMIG consents to a higher price,
(ii) the applicable SMIG company will not be responsible for purchasing GTC Products from GTC, will not take title to GTC Products, and
will not have any material responsibility for marketing, sales or distribution costs; and (iii) at its cost, GTC will support the applicable
SMIG company’s efforts. In such circumstances, the applicable SMIG company will be compensated by retaining the commission and expenses
specified in Section 15.8.
11.4. Generally.
Regardless of whether the applicable SMIG company is a customer, distributor or sales representative:
11.4.1. Separately
for each GTC Product and to the extent reasonable, each region, use, customer or customer category, the Parties shall mutually agree on
the specifications of GTC Products and services to be offered, including any related support services and warranty terms, provided that
the Parties intend the pricing, services and warranties to be reasonably customary for similar products and services purchased by such
customers.
11.4.2. For clarity,
SMIG is not required to pay a royalty or similar payment to GTC with respect to GTC Products purchased by SMIG, its sub-distributors,
or customers; rather, GTC will derive its profit with respect thereto from the purchase price paid to GTC for such GTC Products.
11.4.3. For clarity,
arranging advertising and publicity, regardless of the media, or whether the target is consumer, business, or otherwise, is a Phase B
Service.
12. IndiaCo
Products:
12.1. Right.
Except as set forth in Section 12.2, IndiaCo has the right, but not the obligation, to manufacture, distribute and sell or cause the
manufacture, distribution and sale of IndiaCo Products in the Territory and to or for the NGO Group. Prior to offering IndiaCo Products
for sale in any country or region of the Territory or to or for the NGO Group, or from time-to-time thereafter, if SMIG elects to request
GTC to participate in funding its Deductible Costs, SMIG shall deliver a Notice to GTC setting forth a proposal. The Parties thereafter
shall negotiate in good faith with respect to those IndiaCo Products, the portion of the Deductible Costs with respect thereto, the period
of funding and the country of sale, to be funded by GTC. IndiaCo’s Product Net Profits from the distribution and sale of the relevant
IndiaCo Products and GTC Products
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shall be allocated as set forth in Section 14.6. SMIG
may require GTC to pre-fund its budgeted contribution to Deductible Costs.
12.2. Limitation
on Right. IndiaCo shall not distribute or sell an IndiaCo Product in any country of the Territory or to or for the NGO Group that
is substantially the same as a GTC Product that is a Licensed Product made available by GTC to IndiaCo for distribution and sale in that
country by IndiaCo, unless: (i) GTC consents thereto; (ii) the GTC Product made available is defective, does not comply with legal requirements
in that country and cannot reasonably be made to comply in a reasonable period given GTC’s financial condition, applicable Rules
and the practical requirements of Regulatory Authorities in that country; (iii) there are persistent or repeated supply interruptions
in the availability to IndiaCo of the GTC Product, or the supply otherwise does not meet demand for such product; or (iv) the market potential
for the GTC Product in that country is materially less than the equivalent IndiaCo Product.
12.3. Royalty.
IndiaCo will pay to GTC a royalty with respect to such sales of IndiaCo Products during the License Period pursuant to Section 14.1
hereof.
13. Enforcement
of Intellectual Property Rights:
13.1. Trademark
and Copyright. As between the Parties: (i) GTC shall have the right to file for and maintain trademark, copyright and other protections
with respect to IndiaCo-IP-G outside the Territory; and (ii) SMIG shall have the sole right to file for and maintain trademark, copyright
and other protections with respect to IndiaCo-IP in the Territory.
13.2. Notice.
In the event either Party becomes aware of any threatened or actual infringement of any Patent Rights, copyrights or trademarks with
respect to Licensed Products, Licensed Methods, GTC-IP, or IndiaCo-IP-G (an “Infringement”), that Party shall notify
the other Party and provide it with all details regarding such possible or actual Infringement.
13.3. Outside
of Territory. Outside of the Territory, as between the Parties, GTC has the sole right and authority to take action in the prosecution,
prevention, or termination of any Infringement.
13.4. Inside
Territory.
13.4.1. Lawsuit
by IndiaCo. As GTC’s exclusive licensee in the Territory during the License Period, SMIG shall have the first right, but not
the obligation, to take action in the prosecution, prevention, or termination of any Infringement inside the Territory. Should SMIG elect
to bring any proceeding against an infringer, whether in court, by arbitration, pursuant to an administrative or regulatory proceeding,
or otherwise, SMIG shall keep GTC reasonably informed of the progress of the action. SMIG shall have the sole right to control the proceeding.
As between the Parties, the expenses of the proceeding or proceedings that SMIG elects to bring, excluding any expenses of GTC, shall
be paid for entirely by SMIG, including reasonable attorneys’ fees. SMIG may enter into agreements with counsel on a contingent
basis as to fees and/or costs, and/or utilize a third party litigation financier. Any fees, costs or participations of the foregoing will
be deducted in the computation of Net Recoveries, provided that notwithstanding the definition of Net Recoveries, one hundred percent
(100%) of any such fees, costs or expenses not advanced using SMIG’s financial resources shall be deducted in the computation of
Net Recoveries, in lieu of two hundred percent (200%) thereof.
13.4.2. Lawsuit
by GTC. If SMIG does not take action in the prosecution, prevention, or termination of a specific Infringement, and has not commenced
negotiations with the infringer for the discontinuance of said Infringement within one hundred eighty (180) days after receipt of Notice,
GTC may elect to commence a proceeding on that specific Infringement only. Any and all expenses, including reasonable attorneys’
fees, incurred with respect to the prosecution, adjudication, or settlement of such suit, including any related appeals, shall be paid
for entirely by GTC. In the event GTC exercises its right to sue
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pursuant to this Section 13.4.2, any and all funds
received due to a settlement or judgment shall be retained by GTC; and no portion of such funds shall be due to SMIG. If GTC does not
exercise the rights under this Section 13.4.2 within one hundred eighty (180) days after SMIG decides not to take action on the specific
Infringement, then all rights to such specific Infringement shall irrevocably revert to SMIG. GTC retains no rights to enforce any GTC-IP
or IndiaCo-IP in the Territory other than as described in this subsection.
13.4.3. Declaratory
Judgment. If a declaratory judgment action is brought naming SMIHC, IndiaCo or any of their respective Subsidiaries or Sublicensees
as a defendant and alleging invalidity or unenforceability of any claims within the Patent Rights, each Party shall promptly Notify the
other and SMIHC may elect, upon Notice to GTC within thirty (30) days after GTC receives Notice of the commencement of such action, take
over the sole defense of the action, provided that GTC shall remain liable for all fees, costs and expenses with respect thereto.
13.5. Counsel.
Each Party shall have the right to be represented by counsel of its own selection and at its own expense in any proceeding described
in this Section 13.
13.6. Cooperation.
Each Party agrees to cooperate fully in any proceeding under this Section 13 that is controlled by the other Party. Each Party shall
make all documents and witnesses available to the other Party in any legal actions, whether as plaintiff, defendant, or other situation,
to fully exploit the rights granted herein.
13.7. Covenant.
Each Party warrants and covenants that it will not challenge the other Party’s rights in GTC-IP or IndiaCo-IP or claim any rights
of invention or proprietary rights inconsistent with this Agreement. As between the Parties, the decision as to whether to litigate matters
pertaining to IndiaCo-IP for uses other than for the GTC Use shall be a decision to be made by SMIG in its sole and unfettered discretion
and as between the Parties, all costs and recoveries pertaining thereto shall belong to SMIG.
IV. Compensation;
Refusal Rights; Term
14. Payments
to GTC. IndiaCo shall pay the following amounts to the Person designated by GlobeStar from time-to-time:
14.1. IndiaCo’s
Purchase of GTC Products: IndiaCo will purchase GTC Products from GTC as described in Section 11.
14.2. Sale
of IndiaCo Products: With respect to the sale or lease of IndiaCo Products by IndiaCo, a Subsidiary thereof or a Sublicensee thereof
in the Territory or to or for the NGO Group during the License Period, a royalty in an amount equal to five percent (5%) of the Net Sales
thereof. Payment thereof will be paid in accordance with Section 17.
14.3. GTC-IP:
With respect to a Sublicense of GTC-IP by IndiaCo or a Subsidiary thereof to a Third Person to develop, distribute or sell services
or products to or for Third Persons during the License Period, a participation in an amount equal to fifty percent (50%) of IndiaCo’s
Net Sales therefrom. No such payment is due for the manufacturing, distribution, sale or lease of GTC Products or IndiaCo Products. Notwithstanding
the foregoing, if SMIG funds any costs of the Sublicensee with respect thereto, then SMIG may elect to deem any products or services of
the Sublicensee to be GTC Products or IndiaCo Products, as applicable. Payment thereof will be paid in accordance with Section 17.
14.4. Litigation:
With respect to Net Recoveries received by SMIG from litigation for Infringement that occurs pursuant to Section 13.4.1 during the
License Period, a participation in an amount equal to fifty percent (50%) of Net Recoveries on a cumulative, cross-collateralized basis
for all such litigation. Payment thereof will be paid in accordance with Section 17.
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14.5. Funding
GTC Product Adjusted Deductible Costs: If, in accordance with Section 11.2.1 hereof, GTC participates in funding a portion of IndiaCo’s
Adjusted Deductible Costs for IndiaCo’s distribution and sale of GTC Products in any country of the Territory or to or for the NGO
Group, an amount equal to thirty percent (30%) of Product Net Profits from the distribution and sale of those GTC Products sold in that
country that GTC participated in funding, multiplied by a fraction, the numerator of which is the amount of Adjusted Deductible Costs
with respect thereto timely funded by GTC and the denominator of which is the total Adjusted Deductible Costs with respect thereto. Payment
thereof will be paid in accordance with Section 17.
14.6. Funding
IndiaCo Product Deductible Costs: If, in accordance with Section 12.1 hereof, GTC participates in funding a portion of IndiaCo’s
Adjusted Deductible Costs for IndiaCo’s distribution and sale of IndiaCo Products in any country of the Territory or to or for the
NGO Group, an amount equal to thirty percent (30%) of Product Net Profits from the distribution and sale those IndiaCo Products in that
country that GTC participated in funding, multiplied by a fraction, the numerator of which is the amount of Adjusted Deductible Costs
with respect thereto timely funded by GTC and the denominator of which is the total Adjusted Deductible Costs with respect thereto. Payment
thereof will be paid in accordance with Section 17.
14.7. Participation
Payable to GTC: Provided GTC timely performs its obligations pursuant to this Agreement, an amount equal to five percent (5%) of IndiaCo’s
aggregate, cross-collateralized Pro Forma Profit Before Tax from (i) sale and distribution of GTC Products and IndiaCo Products in the
Territory and to or for the NGO Group during the Manufacturing and Distribution Period; (ii) sublicensing GTC-IP during the Manufacturing
and Distribution Period; (iii) the Management Fee for manufacturing GTC Products to be sold outside of the Territory, excluding sales
to or for the NGO Group; and (iv) litigation in the Territory pertaining to Infringement of GTC-IP during the License Period. GTC may
allocate the foregoing among its senior executives.
14.7.1. “Pro
Forma Profit Before Tax” means IndiaCo’s profit before taxes from the activities described in the introduction to Section
14.7 as reported on IndiaCo’s India tax returns, provided that: (i) amounts deducted for compensation payable to SMIHC for services
other than any services provided by Spivak, will not exceed 125% of SMIHC’s allocable costs for providing such services; (ii) amounts
deductible for compensation for Spivak’s advisory services will not exceed the larger of the compensation accrued, paid, or payable
for that period to the highest paid officer of GTC, or five percent (5%) of IndiaCo’s gross revenues, (iii) this Section 14.7 participation
payable to GTC will not be deducted; and (iv) if there were losses in a prior year as computed on a pro forma basis, the losses may be
carried forward for purposes of computing Pro Forma Profit Before Tax, regardless of whether such losses may be carried forward for purposes
of computing IndiaCo’s taxable income under India law.
14.7.2. Any accountings
rendered hereunder may be altered to cure omissions or errors. Reports for the participation described in this Section 14.7 will be due
within ninety (90) days after the filing of IndiaCo’s corporate tax returns for the relevant year, and will be adjusted pro rata
for any tax years that include periods during the Term and periods not during the Term. Except as specified in this Section 14.7, this
participation will be governed by Section 17.
15. Payments
to SMIG. GTC shall pay the following amounts to the Person designated by SMIHC from time-to-time:
15.1. Phase
A Services:
15.1.1. For budgeted
Formation Services, a Management Fee of fifteen Thousand Dollars ($15,000), payable on the first to occur of GTC Notifying SMIG to commence
Formation Services, or on commencement of Remaining Phase A Services. For each month after India-LocalCo is formed, and until the Remaining
Phase A Services commence, a Management Fee of Five Thousand Dollars ($5,000) per month, payable on the first business day of each month.
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15.1.2. For budgeted
Remaining Phase A Services, a Management Fee in the amount of Eighty-Five Thousand Dollars ($85,000), payable Twenty Two Thousand five
hundred Dollars ($22,500) on commencement of Remaining Phase A Services, and Twelve Thousand five hundred Dollars ($12,500) per month,
for five (5) months, payable on the first business day of each month. If Remaining Phase A Services continue for more than five (5) months,
the Management Fee for each additional month is Ten Thousand Dollars ($10,000) per month, payable on the first business day of each month.
15.2. Phase
B Services: For budgeted Phase B Services, a Management Fee of Twelve Thousand Five Hundred Dollars ($12,500) per month for the initial
twelve (12) months of Phase B, $17,500 per month for the next six (6) months of Phase B, and Twenty Five Thousand Dollars ($25,000) per
month for the following twelve (12) months of Phase B. Thereafter, for the remainder of the Services Period, the Management Fee will increase
on each anniversary date by not less than the total of five percent (5%) of the rate the prior year, plus the rate of inflation in India
the prior year. The Management Fee will be paid on the first business day of the month.
15.3. Management
Services Agreements: For management services described herein with respect to each Management Services Agreement during the Services
Period, other than the Management Services Agreement for India-LocalCo (compensation for which is included in the Management Fees for
Phase A Services and Phase B Services), a Management Fee of Fifteen Thousand Dollars ($15,000) for formation of the LocalCo, payable prior
to commencement of such services, and commencing when formed, Five Thousand Dollars ($5,000) per month, increasing on January 1 of each
year by an amount equal to the higher of the cumulative rate of inflation in India, or the cumulative rate of inflation in the country
in which the LocalCo is organized, computed from December 2023.
15.4. Clinical
Trials:
15.4.1. With respect
to each Clinical Trial in the Territory during the Services Period, a Management Fee equal to ten percent (10%) of the costs of the Clinical
Trial, payable within ten (10) business days after each calendar month. For clarity, this refers to the actual cost, regardless of who
pays for the trial and inclusive of contributions in kind.
15.4.2. If the
direct cost of the Initial Clinical Trial paid by GTC is less than Fifty Thousand Dollars ($50,000), a Management Fee of fifty percent
(50%) of the savings.
15.4.3. For any
country in the world, outside of the Territory, in which results of a Clinical Trial in the Territory during the Services Period are cited
for manufacturing, marketing, sale or distribution approval, or otherwise permit manufacturing, marketing, sale or distribution: (i) with
respect to the United States, a Management Fee bonus of Five Hundred Thousand Dollars ($500,000), payable One Hundred Thousand Dollars
($100,000) within ten (10) days after receipt of such approval, Two Hundred Thousand Dollars ($200,000) one (1) year after approval, and
Two Hundred Thousand Dollars ($200,000) two (2) years after approval, and (ii) with respect to each other country, One Hundred Thousand
Dollars ($100,000) per country, payable Twenty-Five Thousand Dollars ($25,000) on the first to occur of ten (10) days after receipt of
such approval, or ten (10) days after the first manufacturing, marketing, sale, or shipment of GTC Products into such country, Thirty-Seven
Thousand Five Hundred Dollars ($37,500) one (1) year thereafter, and Thirty-Seven Thousand Five Hundred Dollars ($37,500) two (2) years
after the due date of the first payment for such country.
15.5. Manufacturing:
A Management Fee equal to ten percent (10%) of the costs of manufacturing GTC Products in the Territory, payable within ten (10) business
days after each calendar month during the Services Period and continuing thereafter with respect to each manufacturer selected during
the Manufacturing and Distribution Period until the conclusion of all manufacturing activities by such manufacturer.
15.6. Marketing
Services: A Management Fee of fifteen percent (15%) of any costs incurred during the Services Period related to the creation and production
of advertising, whether for business-to-business, for
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consumers, or otherwise and fifteen percent (15%)
of the price of purchased media, including print, broadcast, television, streaming, social media, Internet, radio, or otherwise.
15.7. Additional
Services/Work Orders: For any Additional Services, Management Fees as provided for in the applicable Work Order, payable as provided
for therein.
15.8. Sales
Agent: For SMIG’s sales agent and representative efforts pursuant to Section 11, (i) SMIG shall be entitled to retain a commission
of fifteen percent (15%) of GTC’s Net Sales derived therefrom, whether received during or after the Term; and (ii) GTC shall reimburse
all costs and expenses incurred by SMIG with respect to such services. The balance of the proceeds from such sales shall be remitted to
GTC in accordance with Section 17.
15.9. Certain
Breaches: If GTC or any sublicensees, distributors, sales agents or customers of GTC sells, licenses or ships any GTC Products or
GTC Methods in the Territory, and/or to or for the NGO Group in violation of Section 2.5 hereof, as minimum non-exclusive damages, GTC
shall pay to SMIHC an amount equal to fifty percent (50%) of the consideration received by GTC from selling or licensing the GTC Products
or GTC Methods improperly sold.
16. Fees
Costs and Expenses; Budgets; Deposits.
16.1. General
Principle. Except as provided in this Agreement, and regardless of whether included in a budget, the basic principle is that it is
GTC’s responsibility to advance, reimburse or otherwise promptly and timely fund all fees, costs and expenses:
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of, or related to all LocalCos; |
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for the formation and registration of IndiaCo; |
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incurred by SMIG related to IndiaCo Services; and |
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arising from or related to Clinical Trials, regulatory filings and procedures, Intellectual Property Rights, and manufacturing, including in each instance, among other fees, costs and expenses, all budgeted, otherwise pre-approved, and/or reasonably necessary legal, accounting and expert fees, including SMIG’s fees for drafting and negotiating this Agreement; all filing, maintenance and similar fees; all office expenses, including rent for any LocalCo and/or IndiaCo offices in the Territory, and equipment, supplies and staff for each office; and all VAT, sales tax, excise fees, import fees, export fees, custom duties and similar fees, costs and expenses. |
Without limitation of the foregoing, with respect
to LocalCos and SMIG, among the fees, costs and expenses for which GTC is responsible are: all transportation, lodging, food and incidental
costs incurred for local, national and international travel (business class or, when not available, first class for Kenin M. Spivak (“Spivak”)
and Shekar Tirumalai (“Tirumalai“), provided that in no event will Spivak or Tirumalai be required to fly in a n inferior
class to the class of travel utilized by GlobeStar’s chairman or CEO. For clarity, the costs for which GTC is responsible and liable
includes all SMIG staff who participate in providing IndiaCo and/or LocalCo services (reasonably allocated for individuals who also have
other duties), provided that GTC shall not be required to fund compensation paid to Spivak or Tirumalai. To the maximum extent feasible,
legal and financial responsibility for payments to Third Persons engaged with respect to Clinical Trials, regulatory approvals, Intellectual
Property Rights, manufacturing, and other IndiaCo Services will be LocalCo responsibilities. For clarity, these items are not SMIG’s
financial responsibility and the Parties will take all reasonable steps to ensure that third Persons acknowledge and agree that SMIG is
not liable for GTC’s financial obligations.
16.2. Budget
Approval. Each Work Order will include a budget for not less that the initial twelve (12) month period of that Work Order, unless
another period is mutually agreed by the Parties. Without
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limiting the foregoing, Appendix 5.2.1 includes
the approved budget for Phase A Services, and Appendix 5.2.2 includes the approved present estimated budget for the first twelve
(12) months of Phase B Services, provided that such Phase B budget shall be updated during Phase A. To the extent practicable, budgets
shall include all fees, costs and expenses related to the applicable period of the Work Order, as provided for in this Agreement, provided
the Parties acknowledge that certain costs are incapable of being accurately budgeted, such as litigation fees and costs or negotiation
fees and costs, both of which depend on the decisions and actions of adverse Third Persons. With respect to updates to the budget for
the first twelve (12) months of Phase B Services, budgets for subsequent years of Phase B Services, or otherwise updated budgets for all
Work Orders, GTC shall not unreasonably withhold consent to a budget recommended by SMIG as being reasonably necessary to achieve the
objectives for that Work Order. GTC acknowledges that though Tirumalai will allocate a portion of his time to managing IndiaCo, he and
IndiaCo will require appropriate support and staff, and the number and compensation of such individuals likely will increase as activities
expand, including the addition of LocalCos outside of India. It would be unreasonable for GTC to object to adequate staffing for IndiaCo
and competitive compensation to attract and retain such staffing, including support, clerical, administrative, management and operating
personnel. For clarity, the budgets for Formation Services, Phase A and Phase B do not include Management Fees, Clinical Trials, manufacturing
costs or litigation.
16.3. Spending
Authority. Notwithstanding anything to the contrary in this Agreement, if SMIG or a LocalCo incurs a fee, cost or expense pursuant
to this Agreement related to any items for which GTC is responsible pursuant to this Agreement, regardless of whether that item has been
pre-paid by GTC or included in a Deposit, GTC is responsible for the cost of such item, without any requirement that SMIG or any LocalCo
obtain any further approvals or consents from GTC, in the following circumstances:
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all amounts included in a budget approved by GTC, including: (a) SMIG may re-allocate among items within each category, (b) SMIG may spend up to one hundred twenty percent (120%) of the amount budgeted for a category plus any savings realized in other categories, but, except as set forth in this Agreement, not more than the aggregate amount of such budget, inclusive of the contingency; |
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any overbudget amounts caused by an event of force majeure, GTC’s breach of this Agreement or failure to timely provide to SMIG the information it seeks, or the failure or other breach of a Third Person; |
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any overbudget amount caused by a decision made by GTC or approved of by Notice from GTC; |
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any legal, expert or similar Third Person professional fees, or internal SMIG or LocalCo costs reasonably appropriate investigate Infringement or other claims, or to undertake litigation, negotiations, regulatory filings, or Intellectual Property Rights filings; or |
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as provided for in this Agreement with respect to indemnification, or otherwise. |
16.4. Deposit
Guidelines. Except as set forth in this Agreement, including a Work Order, prior to each of commencement of any Work Order, formation
of any LocalCo, entering into a contract for any Clinical Trial, execution of a manufacturing contract, commencement of litigation, or
any other major activity not funded through a prior Deposit, or a top-up for a prior Deposit, GTC shall fund a Deposit computed by SMIG
in accordance with the following principles: the guiding principle for each Deposit is that it will be sufficient to pay for not less
than the following, to the extent not otherwise funded by direct payments previously made by GTC, or a previous Deposit: (i) the next
twelve (12) months of SMIG Management Fees for that Work Order, plus (i) all SMIG fees, costs and expense for the next twelve (12) months
of that Work Order, plus (iii) the next twelve (12) months of formation and operating costs for all LocalCos relevant to that Work Order,
plus (iv) the next six (6) months of other budgeted costs for that Work Order, plus (v) any non-cancellable fees, costs or expenses of
that Work Order that would be due within the next twelve (12) months, to the extent not otherwise
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included in a prior category. Unless GlobeStar reasonably
objects to the Deposit or the payees computed by SMIG as being improperly computed in accordance with the principles hereof, GTC shall
fund the Deposit within thirty (30) days after receipt of the funding Notice. If GTC reasonably objects, the Parties shall consult to
resolve their difference, following which GTC shall promptly fund the Deposit.
16.5. Top-Ups.
For a Work Order that anticipates performance over a period exceeding six (6) months, if requested to do so by SMIG, not more often
than quarterly, GTC will “top up” the Deposit so that it includes the amounts described in this Section 16 through the date
twelve (12) months after the top up Deposit is made.
16.6. Certain
Specific Deposits. The Deposit for Formation Services (“FS Deposit”) is $77,000. The initial Deposit for Remaining
Phase A Services (“Phase A Deposit”) is $350,000, or if Formation Services are combined with Remaining Phase A Services,
a reduced total of $395,000. The Deposit for the Initial Clinical Trial (“ICT Deposit”) is estimated to be $55,000
and will be refined by SMIG during Phase A. The initial Deposit for the first year of Phase B Services (“Phase B Deposit”)
is estimated to be $825,000 and will be refined by SMIG during Phase A. SMIHC intends to form IndiaCo at the inception of Phase A. If
GlobeStar requests SMIHC to form IndiaCo prior thereto, GTC will pay a Deposit of $13,000 to reimburse the costs of such formation and
the Phase A Deposit will be reduced by a like amount. For clarity, GTC is responsible for the cost for forming and registering IndiaCo,
but not continuing corporate fees. If IndiaCo shares offices or similar corporate items with GTC there will be no allocation of the cost
to SMIG, provided that if there is an additional cost for IndiaCo’s sharing the resource, that additional cost will be credited
as a reduction against the next Management Fees thereafter payable to SMIG pursuant to this Agreement.
16.7. Allocation
of Deposits. As mutually agreed by the Parties, each Deposit may be allocated and deposited into multiple accounts, including accounts
in the names of one or more LocalCos that are liable for the payment of such sums, and accounts designated by SMIG for Management Fees
and amounts that will be incurred or paid by SMIG. Regardless of the number of accounts, the amounts so deposited for a single Work Order
or activity are within the definition of “Deposit.” Subject to tax and legal advice, it is intended that pursuant to Management
Services Agreements, IndiaCo or other SMIHC designee will have the right to cause payments to be made from such LocalCo bank accounts
consistent with this Agreement.
16.8. Payment
of Costs. It is the Parties’ intention that the Deposits will pre-pay the fees, costs and expenses to be paid by LocalCos and
SMIG, with the result that there always will be adequate funds to pay the foregoing. To the extent any Deposit is insufficient, within
five (5) business days after receipt of an invoice from SMIG, or such longer period provided for in an invoice from a Third Person, GTC
shall directly pay or reimburse, as requested by SMIG, the amounts shown as due.
16.9. Return
of Deposits. Any interest earned on the accounts holding the Deposit will be applied to pay fees of the accounts, and thereafter,
net of taxes, to pay for fees, costs and expenses of the related Work Order. If the services to be provided pursuant to a Work Order ends,
and all fees, costs and expenses related thereto have been paid, and there is a remaining balance in the account, unless GTC designates
otherwise, the balance will be returned to GTC.
16.10. IndiaCo
Services. SMIG shall not be obligated to render any IndiaCo Services with respect to any Work Order prior to the completion of all
required Deposits for that Work Order. SMIG may suspend or limit services if any Deposit is not topped up within thirty (30) days after
SMIG requests such top up. No suspension of services relieves GTC of its obligations to pay Management Fees or reimburse SMIG’s
fees, costs and expenses, or extends any Period.
17. Certain
Payment Procedures:
17.1. Accounting
Reports. Within ninety (90) days after the conclusion of each of the first three calendar quarters of the year and one hundred twenty
days (120) days after the conclusion of the last calendar
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quarter of the year and until completion of the payment
obligations herein, whether during or after the Term, each Party shall deliver to the other by Notice a report containing the following
information:
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with respect to GTC, its Net Sales from its sale of IndiaCo Products, if any and information available to it on the costs of Clinical Trials and manufacturing costs used to compute SMIG’s compensation hereunder; |
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with respect to IndiaCo, (a) its Net Sales from its sale GTC Products and IndiaCo Products, its Net Sales from sublicensing, Net Recoveries, and any fees, costs or paid by IndiaCo that are funded by GTC, reimbursed by GTC, or to be reimbursed by GTC, (b) and information available to it on the costs of Clinical Trials and manufacturing costs used to compute SMIG’s compensation hereunder, and (c) if relevant to any payments due to GTC hereunder, Deductible Costs by major category and Product Net Profits; and |
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with respect to both Parties, a computation of the total amounts payable to the other Party in U.S. Dollars for the applicable accounting period, together with the Exchange Rates used for conversion. |
Any accountings rendered hereunder may be altered
to cure omissions or errors. In case of litigation involving partial settlements, or multiple defendants in which some of the defendants
settle, or when payment of legal fees and costs are not yet satisfied, the Party funding that litigation may maintain reasonable reserves
from its gross receipts for anticipated expenses related to the computation of Net Recoveries for the next 12 months that are deductible
hereunder. Each Party shall endeavor to reconcile and reduce reserves at the time of its annual report. Notwithstanding the foregoing,
until six (6) months after Phase B commences, except with respect to the payment to SMIG of compensation pertaining to Clinical Trials,
reports instead will be due within ninety (90) days after the second calendar quarter of the year and one hundred twenty days (120) days
after the conclusion of the last calendar quarter of the year.
17.2. Payment.
Within thirty (30) days after issuance of the reports, the Party that has a net payable to the other Party shall pay such sum by wire
transfer, without any deductions or withholding, except as required by applicable Rule.
17.3. Disagreements.
In the event of any disagreement regarding the computation of any royalty, fee, participation or expense, the portion not in dispute
shall be timely paid or delivered and that portion in dispute promptly shall be deposited with a mutually agreed lawyer, accountant or
other escrow.
17.4. Currency.
All payments due under this Agreement will be paid in U.S. Dollars. Conversion of foreign currency to U.S. Dollars will be made at
the Exchange Rate as of closing of the last business day of the applicable calendar quarter.
17.5. Late
Payments. Any payment that is not paid on or before the date such payment is due under this Agreement will bear interest at the lower
of (i) one and one half percent (1.5%) per month, or part of a month, and (ii) the maximum rate allowed by law. Interest will accrue beginning
on the first day following the due date of payment and will be compounded monthly.
17.6. Suspension
Right. If GTC fails to pay any amounts due to SMIG pursuant to this Agreement and fails to cure any failure within ten (10) business
days, SMIG may by Notice to GTC suspend providing services to GTC under this Agreement. The suspension of services by SMIG shall not be
considered a breach of this Agreement by SMIG. If GTC pays past due amounts, SMIG’s suspension of services shall end, provided that
if GTC fails to pay amounts properly payable within ninety (90) days after the commencement of a suspension, SMIG may by written notice
to GTC terminate its obligations to render services to GTC under this Agreement. No suspension of services relieves GTC of its obligations
to pay Management Fees or reimburse SMIG’s fees, costs and expenses, or extends any Period.
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17.7. Records
and Audits. Each Party shall maintain, and shall cause its Subsidiaries to maintain records required for the computation of amounts
payable hereunder for at least two (2) years after the conclusion of the accounting period during which such amounts were initially reported.
Each Party will have the right, at its expense, to have an authorized representative inspect such records for the purposes of verifying
the accuracy of any reports and payments delivered under this Agreement. There will not be more than one audit in any calendar year. Any
audit will occur during a mutually convenient period, during regular business hours at the location where records are located in a manner
that does not interfere in Soma’s activities and for a period not to exceed thirty (30) days. The Parties may agree to an alternative
method to perform the audit. The authorized representative shall concurrently deliver its report to both Parties. The Parties shall endeavor
to reconcile any underpayment or overpayment within thirty (30) days after the authorized representative delivers the results of the audit.
Any underpayment or overpayment shall be remitted to the other Party within five (5) business days from the date of the reconciliation.
If the Parties cannot agree to a reconciliation within thirty (30) days, a neutral auditor shall be engaged to complete the audit. The
cost of the neutral auditor shall be paid by the Party substantially at fault in the reconciliation. If the Parties agree, or an arbitrator
determines, that any such audit revealed an underpayment in excess of ten percent (10%) in any calendar year, the underpaying Party shall
reimburse the other for all reasonable amounts incurred in connection with such audit.
18. IIP
Period; Term; Termination of Term:
18.1. IIP
Period. The period of the license in IndiaCo-IP-G to GTC pursuant to this Agreement shall commence on the date on which GTC pays all
sums due pursuant to the related Work Order and, shall continue thereafter on an exclusive basis in each country until there are no Valid
Claims in that country and on a non- exclusive basis in perpetuity (the “IIP Period”). SMIG shall not have any early
termination rights for the IIP Period.
18.2. Term.
18.2.1. The Period
of the license in GTC-IP granted to SMIG pursuant to this Agreement shall commence on the Effective Date and, unless earlier terminated
as provided herein, shall continue in full force and effect until there are no further Valid Claims (the “License Period”).
GTC shall not have any early termination rights for the License Period, except as specified in Sections 18.3, 18.4.1, 18.4.2, or 18.4.3.
18.2.2. The Period
during which IndiaCo Services will be rendered shall commence on the Effective Date and, unless earlier terminated as provided herein,
shall continue unless and until all IndiaCo Services are completed (the “Services Period”). GTC shall not have any
early termination rights for the Services Period, except as specified in Sections 18.3, 18.4.1, 18.4.2, or 18.4.3.
18.2.3. The Period
of the manufacturing, distribution and sales agency rights granted to SMIG pursuant to this Agreement shall commence on the Effective
Date and, unless earlier termination as provided herein, shall continue until the last to occur of the end of the License Period, Services
Period and SMIG’s completion of all manufacturing, sales and Sublicenses for GTC Products entered into during the License Period
or Services Period, and for up to one additional year for SMIG to sell is inventory of GTC Products (the “Manufacturing and Distribution
Period”). GTC shall not have any early termination rights for the Manufacturing and Distribution Period, except as specified
in Sections 18.3, 18.4.1, 18.4.2, or 18.4.3.
18.3. Suspension
of Term. If GTC does not obtain financing for Phase A and commence Phase A within ninety (90) days after the Effective Date, or if
GTC does not obtain financing for Phase B and commence Phase B within one year after the Effective Date, SMIG may suspend its obligations
under this Agreement at any time until the foregoing is cured upon ten (10) days prior Notice to GTC, without cause. Following such suspension:
(i) all of GTC’s obligations to SMIG hereunder remain in full force and effect, and (ii) if GTC later obtains financing and sends
a Notice to SMIG that it is prepared to commence Phase A or Phase B, as applicable, then within fifteen (15) business days thereafter,
SMIG shall send a Notice to GTC that either terminates the
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suspension, or terminates the Term. If SMIG fails
to timely send a Notice making such election, then by Notice to SMIG sent prior to the time SMIG sends such Notice, GlobeStar may terminate
the Term.
18.4. Termination
Process.
18.4.1. Termination
by Both Parties. The Parties may terminate all or any Periods on a country-by-country basis by mutual written agreement on such terms
as they may mutually agree in that agreement.
18.4.2. Termination
by Either Party. Either Party (the “terminating Party”) may terminate the Services Period, Manufacturing and Distribution
Period, and/or License Period on a country-by-country basis by Notice to the other Party as follows: (i) if the other Party liquidates
its assets or dissolves its business without first assigning this Agreement to a solvent Person, subject to the terminating Party’s
approval of such assignee, not to be unreasonably withheld; or (ii) the other Party ceases its business operations without first assigning
this Agreement to a solvent Person, subject to the terminating Party’s approval of such assignee, not to be unreasonably withheld.
Under this clause, the effective termination date shall be the day specified in the termination Notice. If the terminating Party terminates
any of the Services Period, Manufacturing and Distribution Period or License Period pursuant to this Section 18.4.2, then by Notice to
the terminating Party, the other Party may then terminate the remaining Periods within sixty (60) days thereafter.
18.4.3. Termination
by GlobeStar. In the event that SMIG commits a material breach of this Agreement and fails to cure that breach within sixty (60) days
after receiving Notice thereof from GlobeStar that sets forth in reasonable detail the nature of the material breach and the steps required
to cure the breach, then, unless GTC’s material breach or non-performance is a material contributing factor to such breach, GlobeStar
may terminate the portion of the Term that pertains to that breach by Notice to SMIG, i.e., the Services Period, Manufacturing
and Distribution Period, and/or License Period, and in the country or countries to which that breach pertains. The termination Notice
may not be sent prior to the expiration of the sixty (60) day cure period, or after SMIG has substantially cured the material breach.
A termination Notice will be effective ten (10) days after SMIG receives the Notice, provided if SMIG files an arbitration demand disputing
GlobeStar’s right to terminate prior to the end of the ten (10) day period, the termination will be deferred until the time, if
any, the arbitration finds in favor of GTC, or as mutually agreed by written amendment hereto by the Parties. If GlobeStar terminates
any of the Services Period, Manufacturing and Distribution Period or License Period pursuant to this Section 18.4.3 by Notice to GTC,
SMIG then may terminate the remaining Periods.
18.4.4. Termination
by SMIG.
18.4.4.1. SMIG
may terminate the Services Period, Manufacturing and Distribution Period and/or License Period on a country-by-country basis at any time
by Notice to GTC, without cause. Under this clause, the effective termination date shall be sixty (60) days from when GTC receives such
Notice. Notwithstanding the foregoing, if GTC has fully paid for any particular phase of IndiaCo Service, IndiaCo shall complete those
services.
18.4.4.2. In
the event that GTC commits a material breach of this Agreement and fails to cure that breach within sixty (60) days after receiving Notice
thereof from SMIG that sets forth in reasonable detail the nature of the material breach and the steps required to cure the breach, then,
unless SMIG’s material breach or non-performance is a material contributing factor to such breach, SMIG may (i) terminate the Period
or Periods that pertain to that breach by Notice to GlobeStar, and/or (ii) if the breach pertains to SMIG’s sales and distribution
rights, send a Notice to GlobeStar (a “Put Notice”) that requires GTC to acquire SMIG’s manufacturing, sale agent
and distribution business activity regarding GTC Products described herein. For repetitive breaches within eighteen (18) months, the cure
period will be reduced to ten (10) days. The termination Notice or Put Notice may not be sent prior to the expiration of the cure period,
or after GTC has cured the breach.
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In its termination or Put Notice, SMIG shall
set forth the effective date of termination and/or the Put, which may not be more than six (6) months after the date on which the Notice
is sent. If SMIG sends a Put Notice, then Section 18.5 shall govern the process with respect thereto.
18.4.4.3. If
GlobeStar merges with or into another Person and following such merger the majority of the members of the board of directors of the combined
company is not comprised of individuals who prior thereto were members of the board of GlobeStar and the chief executive officer of the
combined company is not the chief executive officer of GlobeStar prior to the other party to the merger acquiring a financial interest
in GlobeStar, or if more than fifty percent (50%) of the shares of GlobeStar are acquired by a Third Person or a group of Third Persons
in a transaction or series of transactions, or if GlobeStar sells substantially all of its assets, then SMIG may do either or both of
the following by sending a termination Notice and/or a Put Notice to GlobeStar sent until six (6) months after SMIG is informed of such
transaction by Notice from GTC:
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Terminate the Services Period on prior Notice of six (6) months to CTC and at such termination receive from GTC and any successor payment in the sum of (a) all fees, costs and expenses then payable to SMIG for the IndiaCo Services, (b) all Management Fees reasonably projected to be due during the three year period following such termination, (c) an amount equal to 2.99x the aggregate Management Fees payable for the twelve (12) month period prior to the giving of Notice. |
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SMIG may require that GTC acquire SMIG’s manufacturing, sale agent and distribution business activity regarding GTC Products described herein. If SMIG sends a Put Notice, then Section 18.5 shall govern the process with respect thereto. |
If SMIG exercises the foregoing rights to
both terminate the Services Period and exercise its Put right, and GTC does not dispute the foregoing, GTC may then terminate the Term
by prior Notice of sixty (60) days, but not prior to the second to occur of the termination date for the Service Period set by SMIG and
the closing of the purchase of SMIG’s sales and distribution business. No such termination will interfere in or modify the payments
described above.
18.5. Put
Process. If SMIG sends a Put Notice pursuant to Sections 18.4.4, then at the effective date of the Put designated by SMIG in its Put
Notice, GTC or its designee will acquire ownership of the manufacturing, sale agent and distribution business activity described herein
upon payment of the purchase price in cash computed as provided for in this section. The purchase price will equal the fair market value
of such business, which shall be not less than the reasonable base case projection of SMIG’s direct margin from such business for
the fifteen (15)-year period commencing on the Put effective date set forth in the Put Notice, discounted to the Put effective date at
a discount rate equal to four percent (4%) above the average Fedfunds rate in the United States at the time of giving of the Put Notice,
provided that in such computation any compensation paid or payable for Spivak’s services shall be disregarded. Every effort will
be made by the Parties to conclude all related activities and documentation so that payment is timely made and the transaction closes
on the Put effective date set forth in the Put Notice, but SMIG shall not be required to transfer the business to GTC until payment of
the purchase price is complete. The transaction will be structured to give the seller capital gains treatment for tax purposes, and will
include no holdbacks. The sale will be on a quitclaim, “as is” and “where is” basis, with representations and
warranties limited to the sellers’ knowledge of any breaches, third party claims, violations of law, encumbrances, liens, defects
of title, or material errors in the historical numbers used to compute the discounted present value. No representations or warranties
will survive closing, and the purchaser shall fully indemnify the sellers for all activities after closing thereof. Any dispute will be
resolved by arbitration as provided for herein. If there is a delay in closing beyond the Put effective date set forth in the Put Notice,
without limiting SMIG’s remedies to seek damages and/or specific
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performance, GTC will pay interest on the purchase
price at the rate equal to two hundred percent (200%) of the discount rate.
18.6. Effect
of Termination.
18.6.1. General. Upon
expiration or termination of a particular Period pursuant to any of the provisions of this Section 18: (i) except as provided for herein,
the relevant rights and licenses granted to the other Party in the relevant country or countries herein shall terminate, all rights in
and to and under the relevant Intellectual Property Rights in the relevant country or countries will revert to Party who owns or created
those rights and the other Party shall cease further use or exploitation of the relevant Intellectual Property Rights in that country
or countries; (ii) all Sublicense agreements shall survive the termination of this Agreement each Party shall continue to pay any compensation
payable pursuant to this Agreement with respect to such Sublicense agreements, and (iii) GTC shall pay to SMIG any accrued and unpaid
Management Fees or other sums due to SMIG.
18.6.2. Termination
by SMIG for GTC’s Breach. In addition to its other rights or remedies arising from GTC’s breach, all of which are reserved,
if SMIG terminates the Services Period pursuant to Section 18.4.4.2, GTC shall pay SMIG the amounts specified in clause (i) of Section
18.4.4.3.
18.6.3. Accruing Obligations.
Termination or expiration of the Term shall not relieve the Parties of obligations accruing prior to such termination or expiration,
including obligations to pay amounts accruing up to the date of termination or expiration.
18.6.4. Survival.
The Parties’ respective rights, obligations, and duties under Sections 1, 3, 4, 18.6, and 23 through 33, and any rights, obligations,
and duties which by their nature extend beyond the expiration or termination of the Term, shall survive any expiration or termination
of the Term.
V. Certain
Other Provisions
19. Cooperation;
Approvals:
19.1. Documents.
Each Party shall promptly execute, acknowledge, deliver and file, or promptly procure the execution, acknowledgement, delivery and
filing, of any and all further agreements and instruments which may be necessary or expedient to effectuate the purposes of this Agreement.
19.2. Consultation.
The Parties shall regularly consult regarding major issues to be determined by the Parties, or either of them, regarding the subject
of this Agreement.
19.3. Control.
Except as set forth in this Agreement, as between the Parties, with respect to IndiaCo Services and GlobeStar’s other rights
hereunder, GlobeStar has the final decision as to the matters for which such services are provided, with such approval right to be exercised
reasonably, promptly and in accordance with the Parties respective rights and obligations hereunder. GlobeStar is responsible for any
additional costs arising from any delay or inconsistency in its decisions. Except as set forth herein, with respect to SMIG’s exercise
of its distribution and sales agency rights, matters pertaining to IndiaCo-IP, IndiaCo Products, and/or SMIG’s other rights hereunder,
SMIG shall have the right to control its activities hereunder, provided that SMIG shall not willfully sell or ship products to Persons
in locations where it SMIG knows it would be unlawful to do so. Notwithstanding the foregoing, no Party shall be required to do or not
do something that violates any Applicable Law or its rights pursuant to this Agreement.
19.4. Process.
Where this Agreement requires that GTC or GlobeStar approve of, or consent to, a budget, plan, contract, action, waiver or other matter
to be undertaken by SMIG, GTC shall act promptly to consult with SMIG and to obtain all information reasonably necessary for it to make
a decision. If GTC or GlobeStar does not approve, disapprove, consent, or fail to consent to the SMIG request within ten (10) business
days after the Notice request such approval (or such lesser period if exigencies so require), such
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request shall be deemed approved. In no event shall
GTC condition its approval or consent on a variance from the terms of this Agreement, except that GTC may do so where the SMIG request
is for a waiver of the terms of this Agreement, provided that any GTC conditions are reasonable and consistent with the overall premises
of this Agreement.
20. First
and Last Refusal Rights:
20.1. Refusal
Rights. During the Term, if GTC proposes to seek distribution, sales agents, manufacturing, licensees or other services in all or
any countries of the Territory or to or for the NGO Group with respect to any GTC product, Intellectual Property Rights, or service, other
than a GTC product, Intellectual Property Right or service licensed to SMIG hereunder in the Territory, then prior to soliciting, discussing
or negotiating with any Person to undertake the foregoing, GTC will send a Notice to SMIHC setting for the rights GTC proposes to exercise
and strictly complying with the following:
20.1.1. Negotiation.
For a period of sixty (60) days after SMIHC receives the Notice, GTC and SMIHC shall negotiate exclusively with respect to SMIG undertaking
such activities in such countries, provided that by Notice to GlobeStar, SMIHC may waive or shorten this period. If the Parties do not
reach agreement within such sixty (60) day period, or if agreement is reached and the transaction does not close within one hundred twenty
(120) days after SMIHC receives such Notice, then GTC may seek Third Persons to undertake such activities in such countries and may negotiate
and enter into agreements with other Persons with respect thereto, but may not enter into any binding agreement with any Third Person
with respect thereto without first strictly complying with the refusal rights described in Section 20.1.2. The foregoing rights will revive
as to any such activities and countries for which GTC does not enter into a transaction with a Third Person within nine (9) months after
the end of the foregoing period.
20.1.2. Matching.
If, after satisfying its obligations under Section 20.1.1, GTC receives a bona fide offer from a Third Person for such activities
and GTC intends to accept such offer, then before doing so, and, in any event, prior to and as a condition to, the effectiveness of such
agreement, GTC shall send a Notice to GTC that includes a complete and unredacted copy of the contract and other deal memoranda for the
proposed transaction, and offers to SMIG the irrevocable right and option for ten (10) days to select a designee to enter into such agreement
in place of the Third Person on the same terms, except that Sections 17 to 33 of this Agreement, excluding Section 20 and inapplicable
provisions of Section 18 shall replace the equivalent provisions of the proposed contract. If SMIG does not send GTC a Notice accepting
that offer within that period, the offer will expire and within the following one hundred twenty (120) days GTC may enter into that proposed
agreement with the Third Person. If GTC does not enter into that agreement with the Third Person within such period, then SMIG’s
right of last refusal will revest and shall pertain to subsequent offers received by GTC.
21. Compliance
with Law: During the Term, each Party represents and warrants that it will comply, and will ensure that its Subsidiaries and Sublicensees
comply, with all local, state, federal and international laws and regulations relating to the development, manufacture, use, sale and
importation of products and services. Without limiting the foregoing, each Party represents and warrants, on behalf of itself and its
Subsidiaries and Sublicensees, that they shall comply with all laws and regulations controlling the export of certain commodities and
technical data, including without limitation all Export Administration Regulations of the United States Department of Commerce. Among
other things, these laws and regulations prohibit or require a license for the export of certain types of commodities and technical data
to specified countries. Each Party hereby gives written assurance that it will comply with, and will cause its Subsidiaries and Sublicensees
to comply with, all United States export control laws and regulations, that it bears sole responsibility for any violation of such laws
and regulations by itself or its Subsidiaries or Sublicensees, and that it will indemnify, defend, and hold the Indemnitees harmless (in
accordance with Section 31) for the consequences of any such violation.
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22. Data
Security: During the Term, each Party will comply with any applicable data protection and privacy legislation in force anywhere in
India and the United States and shall (i) establish and maintain appropriate administrative, technical and physical safeguards to protect
the security, integrity, confidentiality and availability of Data; (ii) protect against any actual or anticipated threats, hazards, viruses,
unauthorized or unlawful access to, use of, or disclosure of, Data; (iii) within seventy-two (72) hours Notify the other Party of any
actual or suspected breach of this Section 21, if any Data is or is suspected to be lost, stolen, corrupted, used or disclosed to any
Third Person except in accordance with this Agreement and fully cooperate with the other Party to investigate and resolve any such Data
event; (iv) ensure that those to whom the Party provides access to Data are aware of and comply with the provisions of this Section 21;
and (v) maintain, and upon request provide the other Party with a copy of, data privacy, security, and disaster recovery policies and
procedures applicable to such Data.
23. Confidentiality:
23.1. Definition.
“Confidential Information” means all information that is of a confidential and proprietary nature to GTC or SMIG
and provided by one Party (the "Discloser") to the other Party (the "Recipient"), provided that information
shall not be considered Confidential Information of a Discloser under this Agreement to the extent that the Recipient can establish by
competent written proof that such information: (i) was in the public domain at the time of disclosure; or (ii) later became part of the
public domain through no act or omission of the Receiving Party, its employees, agents, successors or assigns in breach of this Agreement;
or (iii) was lawfully disclosed to the Receiving Party by a Third Person having the right to disclose such information not under an obligation
of confidentiality; or (iv) was already known by the Receiving Party at the time of disclosure; or (v) was independently developed by
the Recipient without use of the Discloser’s Confidential Information.
23.2. Protection
and Marking. During the Term and for a period of thirty-six (36) months thereafter, all Confidential Information disclosed by Discloser
in tangible form, and marked “confidential” and forwarded to the Recipient, or if disclosed orally, is designated as confidential
at the time of disclosure: (i) is to be held in strict confidence by the Recipient, (ii) is to be used by the Recipient only as authorized
in this Agreement, and (iii) shall not be disclosed to any Third Person by the Recipient, its agents or employees without the prior written
consent of the Discloser or as authorized in this Agreement. Each Party has the right to use and disclose Confidential Information of
the other Party reasonably in connection with the exercise of its rights under this Agreement, including without limitation disclosing
to Subsidiaries, Sublicensees, investors, insurers, acquirers, potential investors, insurers and acquirers, and others on a need to know
basis, if such Confidential Information is provided under conditions which reasonably protect the confidentiality thereof. The Recipient’s
obligation of confidence hereunder includes, without limitation, using at least the same degree of care with the Discloser’s Confidential
Information as Recipient uses to protect its own Confidential Information, but always at least a reasonable degree of care.
23.3. Disclosure
Required by Regulatory Authority, Court Order, or Law. If the Recipient is required to disclose Discloser's Confidential Information,
or any terms of this Agreement, pursuant to the order or requirement of a Regulatory Authority, court, administrative agency, or other
governmental body or applicable Rule, the Recipient may disclose such Confidential Information or terms to the extent required, provided
that the Recipient shall use reasonable efforts to provide the Discloser with reasonable advance Notice thereof to enable the Discloser
to seek a protective order and otherwise seek to prevent such disclosure. To the extent that Confidential Information so disclosed does
not become part of the public domain by virtue of such disclosure, it shall remain Confidential Information protected pursuant to this
Section.
23.4. Publicity.
Notwithstanding the foregoing, the Parties may issue press releases and otherwise advertise and publicize its activities under this
Agreement, provided that no press release shall mention SMIHC or any affiliate or officer thereof without SMIHC’s prior approval
by Notice. The Parties shall consult prior to issuing any such press releases announcing this Agreement or any amendment, suspension or
termination of
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any Period hereof. After announcement of this Agreement,
the foregoing is not intended to prohibit: (i) the Parties and their officers, directors and advisors from engaging in lawful public communications
that accurately describe and lawfully promote the Parties’ business activities pursuant to this Agreement, provided that the Parties
shall not thereby disclose Confidential Information, or (ii) SMIG from engaging in marketing, sales or distribution activities pursuant
to this Agreement.
23.5. Not
Exclusive. Except as set forth herein, neither Party is exclusive to the other Party. Notwithstanding the foregoing, during Phase
A Services and Phase B Services, provided GTC timely pays SMIG and is not in breach or default of any obligations hereunder, IndiaCo will
not undertake services substantially similar to the Phase A Services or Phase B Services in India with respect to products that are substantially
similar to GTC’s MS Licensed Products. For clarity, except as set forth in this Agreement, SMIG and its Affiliates may advise, invest
in, render services for, create opportunities for, distribute for, supply products to, and otherwise engage in activities that are directly
competitive to GTC, or on behalf of customers or vendors to GTC. Except as set forth herein or prohibited by law, nothing herein restricts
SMIG or its Affiliates from rendering services for others or acting as a principal in any business, including actual or potential competitors,
vendors or customers of Client. The Parties acknowledge and agree that Spivak and Tirumalai serves on boards of directors of, invest in,
and advises, companies in health care, some of which may have interests in MS diagnostics and therapeutics and some of which may be conducting
or hereafter undertake Clinical Trials, regulatory filings and Intellectual Property Rights filings, including in the Territory. The foregoing
is not a breach of this Agreement. SMIG shall devote such time to its activities hereunder as it deems appropriate thereto. In the event
SMIG is an investor in, or rendering services for, a Person who engages in a transaction with GTC for which SMIG also renders services
hereunder, except to the extent prohibited from doing so by a non-disclosure agreement or applicable Rule, SMIG will so advise GTC.
23.6. Compliance
with Law. Each Party shall comply with all laws applicable to its activities under this Agreement and its business in general. In
undertaking its activities hereunder, SMIG is not required to do anything unlawful, or to facilitate any activity or transaction that
would violate the laws of any applicable jurisdiction. Each Party may do or refrain from doing that which it believes to be appropriate
pursuant to applicable Rule after consultation with qualified counsel.
24. Non-Solicitation:
Unless otherwise agreed in writing by the Parties, during the Term and for a period of one (1) year after termination of the Term,
neither Party shall directly or indirectly, engage, employ or solicit to employ or engage as a consultant or other independent contractor,
on their own behalf or on behalf of any other Person, the personal services of any individual who was employed by the other Party with
respect to the activities described herein, unless and until that individual ceases to be employed by such Party or any affiliate or Subsidiary
thereof for a period of at least one (1) year. In the event of any violation of this provision, as liquidated damages, the Party violating
this provision shall pay the sum of $500,000 per occurrence to the other Party. The Parties acknowledge that Spivak is an advisor to GlobeStar
on matters that do not include the negotiation and approval process of this Agreement. Accordingly, this Section 23 does not pertain to
Spivak. The Parties also acknowledge that Spivak owns shares of GlobeStar and warrants to purchase shares of Globestar. It is not a breach
of this Agreement for Spivak to provide advice to GTC and/or SMIG.
25. Representations
and Warranties: Except as set forth herein with respect to IndiaCo, each Party hereby represents and warrants and covenants to the
other Party as of the Effective Date as follows:
25.1. Such
Party is an entity duly organized, validly existing, and in good standing under the laws of the jurisdiction of its organization as set
forth in the introduction to this Agreement, with all requisite authority to enter into and perform its obligations under this Agreement.
25.2. Such
Party has taken or caused to be taken all necessary actions to authorize the execution, delivery, and performance of this Agreement, and
this Agreement constitutes a valid and binding obligation of such Party enforceable in accordance with its terms.
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25.3. The
signatory for such Party has full authority to sign on behalf of such Party.
25.4. Such
Party has the right to enter into this Agreement without the approval or consent of any Third Person.
25.5. The
execution and delivery of this Agreement by such Party and the performance by it of its obligations hereunder do not and will not (i)
violate any Rule, license, or agreement applicable to such Party, or (ii) contravene any provision of, or constitute an event of default
under any contract, agreement, instrument or undertaking to which such Party is a party, or violate such Party’s articles of incorporation
or bylaws.
26. Further
Representations by IndiaCo: Upon its formation, IndiaCo further represents, warrants, and covenants the following:
26.1. It
will perform IndiaCo Services in a professional and workmanlike manner, consistent with generally accepted industry standards and good
commercial practices. The Acceptance process described in Section 5.7 shall be the sole remedy for breach of this representation.
26.2. Except
as expressly set forth in the applicable Work Order, all materials developed during the course of performing IndiaCo Services and delivered
pursuant to a Work Order shall not infringe the rights of Third Persons and shall be delivered to GTC free and clear of any liens.
26.3. The
express warranties given in this Agreement are in lieu of all other warranties, express or implied, including any warranties that the
work will be error-free or run without interruption or the implied warranties of merchantability and fitness for a particular purpose.
27. Further
Representations by GTC: GTC further represents, warrants, and covenants the following:
27.1. GTC
is the exclusive licensee of the entire right, title, and interest in and to the Patent Rights.
27.2. The
Soma License Agreement is in full force and effect, there is no outstanding breaches thereof and GTC will not breach any material provision
of that agreement. GTC promptly will Notify SMIHC of any amendment, modification, termination, or breach of the Soma License Agreement
by any party thereto.
27.3. As
of the Effective Date, all other licenses, including exclusive and non-exclusive, that GTC has granted to Third Parties that cover any
aspect of GTC-IP have been terminated or are expired.
27.4. GTC
will not grant any other licenses, either exclusive or non-exclusive, with regard to GTC-IP during the Term of this Agreement and will
not execute any licenses or other agreements relating to GTC-IP that are in conflict with the terms and conditions in this Agreement.
27.5. Appendix
A includes all rights GTC has related to the patents and patent applications listed therein and there are no other patents or patent
applications, in any country, within GTC’s control that cover the same or similar subject matter of such listed in Appendix A.
27.6. To
the best of GTC’s knowledge and belief as of the Effective Date of this Agreement, there are no issued or pending patent applications
relating to the Licensed Products or the Licensed Methods that would prevent SMIHC, IndiaCo or their respective Subsidiaries and Sublicensees,
from exercising its rights under this Agreement.
27.7. GTC
has not been sued, nor received any threat of suit, concerning the Soma License Agreement or the subject matter of GTC-IP.
27.8. There
are no pending reexaminations, reissues, oppositions, or similar actions pending or threatened in any country for any of GTC-IP.
27.9. GTC-IP
is valid, enforceable, and does not infringe any Person’s rights.
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27.10. This
Agreement does not violate any rights held or asserted by Advanced Innovative Partners, Inc.
27.11. GTC
shall use best efforts to seek financing for Phase A, and if Clinical Trials are successful in supported regulatory approvals, also Phase
B.
28. No
Other Warranties: EXCEPT AS EXPRESSLY SET FORTH HEREIN, NEITHER PARTY IS MAKING AND EACH IS EXPRESSLY DISCLAIMING ANY EXPRESS OR IMPLIED
REPRESENTATIONS OR WARRANTIES, INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE,
WITH RESPECT TO THE INDIACO-IP AND ANY PORTION THEREOF AND THE PERFORMANCE OF INDIACO SERVICES PURSUANT TO THIS AGREEMENT.
29. Limitation
of Liability:
29.1. SUBJECT
TO THE INDEMNIFICATION, REPRESENTATIONS, AND WARRANTIES EXPLICITLY PROVIDED HEREIN, NO PARTY WILL BE LIABLE TO THE OTHER, ITS SUBSIDIARIES,
OR ANY SUBLICENSEE WITH RESPECT TO ANY LIABILITY ARISING FROM THE GTC PRODUCTS, GTC-IP, INDIACO PRODUCTS, INDIACO-IP, OR LICENSED METHODS,
OR PERSONAL INJURY, OR PROPERTY DAMAGE ARISING FROM THE MANUFACTURE, SALE, OR DISTRIBUTION OF THE FOREGOING. NOTWITHSTANDING THE FOREGOING,
WHEN SMIG IS A DISTRIBUTOR OF GTC PRODUCTS, GTC REMAINS FULLY LIABLE AND INDEMNIFIES SMIHC, INDIACO AND THEIR RESPECTIVE SUBSIDIARIES,
SUBLICENSEES, CUSTOMERS AND ALL OTHERS CLAIMING THROUGH THE FOREGOING. SMIG HAS NO LIABILITY FOR THE ACTS, OMISSIONS OR DEBTS OF LOCALCOS.
29.2. SMIG
AND ALL AFFILIATES OF SMIHC AND/OR INDIACO AND EACH OF THEIR SUBLICENSEES AND THEIR AFFILIATES DISCLAIM ALL REPRESENTATIONS OR WARRANTIES
OF FITNESS, MERCHANTABILITY, OR OTHER REPRESENTATIONS OR WARRANTIES PERTAINING TO THE EFFECTIVENESS, SAFETY, SIDE EFFECTS OR PERFORMANCE
OF GTC PRODUCTS, GTC METHODS AND INDIACO PRODUCTS. AS BETWEEN THE PARTIES, IN ALL CIRCUMSTANCES AND ALL SITUATIONS, GTC SHALL BE LIABLE
FOR THE FOREGOING.
30. Force
Majeure: If, solely as a result of Force Majeure, a Party is unable to timely perform one or more obligations hereunder, that Party
shall be entitled to either extend the date for performance of such obligations for the lesser of the period the Force Majeure is the
sole cause of non-performance, or the duration of that Force Majeure and ten (10) additional days by providing prompt Notice to the other
Party. Except as set forth in this section, a Party’s failure to perform its obligations under this Agreement solely by reason of
Force Majeure or by reason of the other Party’s non-performance arising from a Force Majeure is not a breach of this Agreement.
Notwithstanding the foregoing: (i) no Party may delay any performance for more than six (6) months as a result of Force Majeure; (ii)
within thirty (30) days after receiving invoices from the other Party, and regardless of the Force Majeure, the Party delaying performance
as a result of Force Majeure shall promptly reimburse the direct out-of-pocket cost incurred by the other Party due to the late performance
and the other Party shall be excused from any non-performance arising from the delay. Both Parties shall endeavor to avoid and reduce
costs arising from any Force Majeure.
31. Indemnification:
31.1. Notification.
GTC shall notify SMIG of any claim, threatened or filed cause of action, lawsuit, or other proceeding (collectively "Claims")
related to GTC-IP and/or GTC Products within five (5) days after learning of such Claim(s).
31.2. Indemnification.
GTC will defend, indemnify, and hold harmless SMIHC, IndiaCo and their respective Subsidiaries and Sublicensees and the owners, directors,
officers, employees, counsel, advisors, agents and representatives of each of the foregoing (the “Indemnified Parties”),
from and against any and all claims, causes of action, lawsuits or other proceedings filed or otherwise instituted against any of the
Indemnified Parties arising out of or related to all or any of: (i) GTC-IP, (ii) GTC’s use or license of IndiaCo-IP,
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(iii) GTC Products, (iv) IndiaCo Products, (v) LocalCos,
excluding only acts taken by SMIG contrary to this Agreement or a Management Services Agreement that were neither approved by GTC nor
disclosed to GTC prior to being taken, (vi) GTC’s breach of this Agreement, or (vii) any other matter pertaining to GTC’s
acts or omissions, regardless of whether related to this Agreement.
31.3. Manner
of Indemnification. As to each of the Indemnified Parties: (i) GTC shall advance all costs, fees, expenses, settlement, judgements,
penalties of any kind or character as incurred, including legal and expert fees and costs related to investigating, defending or settling
such claims, so that the Indemnified Party is not required to advance any funds or obtain reimbursement therefor; (ii) if any allegation
is made that would exclude any indemnification, GTC shall nonetheless provide full indemnification unless and until a non- appealable
court judgment or final and non-appealable arbitration ruling determines that no indemnification was owing pursuant hereto, and in that
event the Indemnified Party who received indemnification shall repay the amount specified by the court or arbitrator, as applicable. SMIG
may at its own cost, participate through its own attorneys in the investigation, defense, settlement, or trial of any Claims for which
any Indemnified Party is named as a defendant. GTC shall provide all assistance requested by SMIG in defending any Claims. For clarity,
if Spivak or any company in which Spivak has a financial interest is a defendant in such action, the defense thereof shall be undertaken
by lawyers and experts selected by Spivak and controlled by Spivak.
31.4. Exceptions.
GTC will have no obligation to defend, indemnify or hold harmless an Indemnified Party for any Claim that is based on: (i) that Indemnified
Party’s gross negligence or willful misconduct that is sustained by a non-appealable court judgement; or (ii) a Claim of intellectual
property misappropriation by that Indemnified Party that is sustained by a non-appealable court judgment, including any claims of intellectual
property misappropriation related to the Patent Rights that is sustained by a non-appealable court judgement.
32. Dispute
Resolution:
32.1. AAA.
Except as set forth herein, or as necessary to obtain injunctive relief, specific performance, similar equitable relief or comply
with an applicable Rule, any dispute, controversy or claim involving, arising out of or related to the validity, interpretation, application
or enforcement of this Agreement or the transactions contemplated hereby, or any breach or application hereof or tort related hereto,
including as to this Agreement’s existence and the validity, termination, scope or enforceability of this agreement to arbitrate
(collectively a “Dispute”), shall be exclusively resolved by binding arbitration before the American Arbitration Association
(“AAA”), whose rules applicable to commercial disputes shall apply except as modified by this Agreement and are hereby
deemed to be incorporated herein by this reference. Service of any papers with respect to such arbitration may be effected by delivering
any required papers in the manner described herein for Notices. Unless the Parties mutually agree otherwise in writing, the arbitration
hearing shall take place in Los Angeles County, California, USA and the Parties consent to venue. The arbitration shall take place before
one arbitrator, who shall be a retired judge. The language of arbitration shall be English and the arbitral award shall be final and binding
on the Parties. The arbitrator shall have the right to award reasonable costs and expenses, including reasonable attorneys’ fees
and expert witness fees, to the prevailing party. The cost of the arbitration shall be paid by the substantially losing party. Each of
the Parties irrevocably submits to the exclusive jurisdiction of such arbitration proceeding, waives any and all objections it may now
or hereafter have based on jurisdiction, venue, convenience of forum, or proceedings described herein and agrees that all claims in respect
of such proceeding shall be heard and determined only by such arbitrator, and agrees not to bring any proceeding arising out of or relating
to this Agreement in any other court or tribunal. Counsel, parties and witnesses not located in the city in which the arbitration occurs
may be deposed and appear at hearings remotely by videotelephony or online peer-to-peer services such as Zoom, Microsoft Teams and Skype.
If there is no agreement on an arbitrator within 60 days after AAA provides a list of proposed arbitrators, then AAA shall appoint the
arbitrator. The arbitrator shall comply with the provisions of this Section unless the parties to the arbitration consent in writing otherwise.
THE PARTIES UNDERSTAND AND ACKNOWLEDGE THAT UNDER THIS SECTION EACH WAIVES THE RIGHT TO TRIAL BY JURY. The award of the
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arbitrator may be entered with any court whose jurisdiction
covers the venue of the arbitration proceeding and such judgment may be enforced with the same force of law as the non-appealable judgment
of a U.S. federal court and may be enforced worldwide against the parties and their assets. To the maximum extent permitted by applicable
Rule, each Party hereby waives and covenants not to assert any defenses regarding the worldwide enforcement of a judgment hereunder, other
than the defense that there has been a prior payment of the judgment, in whole or in part.
32.2. Confidentiality.
The Parties shall maintain the confidential nature of the arbitration proceeding, except as may be necessary to prepare for or conduct
the arbitration hearing, as may be necessary in connection with a court application for a preliminary remedy, a judicial challenge to
an award, the entry of an award in any court having jurisdiction thereof, the enforcement or the award, or as required by law or judicial
decision.
32.3. Court.
If for any reason this Section 32 shall not be sufficient or enforceable as the exclusive means of resolving any and all disputes
relating to this Agreement or any rights created hereby, then all such matters shall be adjudicated exclusively by state or federal courts
in Los Angeles County, State of California, USA. Each Party agrees to submit to the jurisdiction of, and agrees that venue is proper in,
New York County for any such legal action or proceeding.
32.4. MCIA.
Notwithstanding anything to the contrary in this Section 32, SMIG (and not GTC) shall have the right, at its sole election to elect
to have any Dispute referred to and finally resolved by binding arbitration in accordance with the arbitration rules of the Mumbai Centre
for International Arbitration (“MCIA”) for the time being in force, which rules are deemed to be incorporated by reference
in this Section. The seat and venue of the arbitration shall be Mumbai. The arbitral tribunal will consist of three arbitrators. IndiaCo,
GTC and SMIHC shall each appoint one arbitrator, who shall act as the presiding arbitrator. The language of the arbitration shall be English.
Any award by the arbitral tribunal shall be made in writing and shall be final and binding on the Parties. The Parties undertake to carry
out and comply with such award without delay and in accordance with applicable Rules. The arbitral tribunal shall also decide on the costs
of the arbitration proceedings. GTC acknowledges and agrees that only SMIG shall have the foregoing right to elect to have a Dispute referred
to and finally resolved by the MCIA. If by Rule GTC is required to have the foregoing right, GTC hereby waives such right.
32.5. Continuing
Exercise. When any Dispute is under arbitration, except for the matters under Dispute, the Parties shall continue to exercise their
remaining respective rights and fulfil their remaining respective obligations under this Agreement to the extent such rights and obligations
are not affected in any manner by the matters under Dispute.
32.6. Exception.
The arbitration provision herein shall not apply in the event a lawsuit is brought against both Parties by a Third Person; in such
an event, a Party may file a cross-complaint in the same suit if the claim of the cross-complaint arises out of the transaction or occurrence
that is the subject matter of the original action or of a counterclaim.
33. General
Provisions:
33.1. Reference
to Agreement and Sections. The words “hereof,” “herein” and “hereunder” and words of similar import
when used in this Agreement shall refer to this Agreement as a whole and not to any particular provision of this Agreement. Any reference
to this Agreement includes any and all recitals, permitted amendments, supplements, extensions, and renewals of this Agreement, including
each Work Order, provided that unless expressly stated, references to sections within the main portion of this Agreement or any appendix,
or Work Order refers to the sections of that portion of this Agreement.
33.2. Construction.
In this Agreement, unless the context clearly requires otherwise: (i) the plural and singular numbers shall each be deemed to include
the other; (ii) the masculine, feminine and neuter
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genders shall each be deemed to include the others;
(iii) “shall,” “will” or “agrees” are mandatory and “may” is permissive; (iv) “or”
is not exclusive; (v) “includes” and “including” are not limiting and mean “without limitation;” (vi)
“anticipates” and “anticipated” means that there is a current expectation or belief, but not a binding obligation;
and (vii) “promptly” means within five (5) business days after request, unless the exigencies of the situation require a shorter
period. Except as expressly set forth herein, all references to currency are to U.S. Dollars. Unless otherwise indicated in this Agreement,
all accounting terms used in this Agreement shall be construed, and all accounting and financial computations hereunder or thereunder
shall be computed, in accordance with United States generally accepted accounting principles, applied in a consistent manner.
33.3. Interpretation;
SMI Conflicts; Legal Counsel.
33.3.1. Each
Party has had access to legal counsel of its choice prior to the execution of this Agreement and has obtained such advice as it has required
to understand and negotiate this Agreement. Accordingly, this Agreement shall not be construed or resolved using any presumption against
any Party. Any ambiguity or uncertainty shall be construed and interpreted according to the ordinary meaning of the words so as to fairly
accomplish the purposes and intention of the Parties. The Parties waive the benefit of any statute or principal providing that in cases
of uncertainty, language of a contract should be interpreted most strongly against the Party who caused the uncertainty to exist.
33.3.2. Spivak
is a shareholder of GlobeStar and Spivak Management Inc. (“SMI-Inc.”) has a consulting agreement with GlobeStar pursuant
to which SMI-Inc. provides Spivak’s services to advise GlobeStar on certain matters. The Parties acknowledge that Spivak is the
controlling owner of SMI-Inc. and SMIG and that Spivak is advising SMIG, not GTC, with respect to the terms and conditions of this Agreement,
and any matter arising under this Agreement. Each Party waives any conflict of interest by SMI-Inc. or Spivak arising therefrom. Without
limiting the foregoing, the Parties understand and agree that: (i) with respect to IndiaCo Services, and the other rights and obligations
imposed on SMIG hereunder, and the rights and obligations imposed on GTC hereunder, SMI-Inc. and Spivak will be acting in the best interests
of SMIG and not as an advisor to GTC; and (ii) SMI-Inc. and Spivak have no obligations pertaining to this Agreement or the performance
thereof to GTC or its shareholders any greater than they would have if there was no other relationship between SMI-Inc. and/or Spivak
and GTC. GTC for itself and its shareholders and creditors waives and releases SMI-Inc. and Spivak from any liability inconsistent with
the foregoing. As among the Parties, no information learned by Spivak in any other relationship he may have now or in the future with
GTC shall be deemed Notice to SMIG or information received by SMIG.
33.3.3. It
has been contemplated that Edward Swanson may render legal services for GlobeStar. Notwithstanding the foregoing, the Parties acknowledge
that Swanson is an owner and general counsel of SMI Group LLC, SMIHC and is expected to be the same for IndiaCo; that he is an attorney
for SMI- Inc. and Spivak, and has provided limited legal advice to GTC on matters unrelated to this Agreement and the transactions contemplated
hereby. Swanson has acted, and will continue to act, as the attorney for SMIG with respect to this Agreement, including SMIG’s and
GTC’s performance hereunder. Although Swanson may hereafter give GTC advice on related matters, such as potentially, GTC’s
disclosure obligations pertaining to this Agreement or the terms of an agreement entered into by a LocalCo with a Medical Institution
for a Clinical Trial, Swanson will not give GTC advice pertaining to its rights under this Agreement as to any subject where GTC and SMIG
disagree, or may disagree. As to matters such as those cited, Swanson may refrain from giving advice if he believes it would be a conflict,
or if SMIG does not consent. If any services for GTC would create a circumstance in which Swanson could not concurrently represent GTC
and SMIG, Swanson will withdraw from representing GTC, particularly because he is an owner of SMIG. The Parties acknowledge and consent
to the foregoing, and waive any potential and waivable conflict arising therefrom.
33.4. Other
Agreements. In the event of any inconsistency between the terms of this Agreement and the terms of any other agreement among the Parties,
the terms of this Agreement shall govern as to the subject matter hereof unless the other agreements expressly provide otherwise. If all
or any of GlobeStar,
Globestar-SMIHC Collaboration Agreement (09-26-2023) Final.docx |
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Soma, or any Affiliate thereof previously entered
into, concurrently enter into, or hereafter enter into, any agreements, arrangements or understandings with all or any of SMI Group LLC,
SMI-Inc., or any Affiliate thereof with respect to any matter whatsoever, such agreements, arrangements or understandings are not and
will not be integrated with this Agreement. Except as expressly provided for in any such other written and fully executed and delivered
agreement, in no event will the performance, non-performance, breach, or any other act or omission relating to arising out of this Agreement
be used as a basis for, or a defense of, any act or omission under any such other agreements, arrangements or understandings. Unless expressly
provided for in a written amendment to this Agreement executed by the CEO of GlobeStar and the CEO of SMIHC, in no event will the performance,
non-performance, breach, or any other act or omission relating to arising out of any or all other such agreements, arrangements or understandings
be used as a basis for, or a defense of, any act or omission under this Agreement. Each party hereby waives the right to assert any contrary
position for any purpose and represents, warrants, covenants and agrees not to do so.
33.5. Assignment.
Neither GTC nor Soma may assign this Agreement without SMIHC’s and IndiaCo’s consent, except that Soma may assign this
Agreement to GlobeStar or a Subsidiary thereof, and GTC may assign this Agreement in connection with a sale of substantially all of its
assets, including the Patent Rights, to a purchaser that expressly and without reservation agrees to perform all of GTC’s obligations
pursuant to this Agreement. SMIHC and IndiaCo may not assign this Agreement, except to an affiliate of SMIHC, unless the assignment is
approved by GlobeStar, such approval not to be unreasonably withheld, conditioned or delayed, provided that SMIHC and/or IndiaCo may assign
this Agreement to a purchaser of substantially all of its assets related to the performance of this Agreement, provided the purchaser
expressly and without reservation agrees to perform all of SMIG’s obligations pursuant to this Agreement. Subject to the foregoing,
this Agreement shall be binding upon and inure to the benefit of the Parties and their respective legal representatives, successors, and
assigns. The Parties acknowledge that SMIG has the right to collaborate with, partner with, or engage a locally owned or controlled Person
in any country to facilitate its activities hereunder, and no such transaction violates this Agreement.
33.6. Third-Party
Beneficiaries and Liability. Except as described in this Agreement, no Third Person is a beneficiary of this Agreement and no Third
Person is a guarantor of the performance by either Party to this Agreement, nor shall any Third Person have any liability with respect
to the performance by either Party to this Agreement. Indemnified Persons are intended Third Person beneficiaries of the indemnification
provisions of this Agreement. GlobeStar and Soma are jointly, primarily and severally liable for the breach of any representation, warranty,
covenant, agreement or obligation herein. A reference to action or obligation of “GTC” is to an action or obligation that
may be performed by GTC and/or Soma, provided the other company shall cooperate in, and facilitate such action or obligation to the extent
that furthers the purposes of this Agreement. Except as set forth in the next sentence (i) SMIHC is not a guarantor of, or liable for,
the performance of IndiaCo, and (ii) IndiaCo is not a guarantor of, or liable for, the performance of SMIHC. From time-to-time, each of
SMIHC and IndiaCo may delegate to a Subsidiary or affiliate the performance of all or any of its services and in such event, SMIHC and/or
IndiaCo, as applicable, will remain liable to GTC for the performance of such Subsidiary or affiliate, but the Subsidiary or affiliate
will not be liable to GTC. SMIG is not a guarantor of, or liable for, the performance of the LocalCos.
33.7. No
Partnership. This Agreement does not create a partnership, joint venture or fiduciary relationship. Each Party’s obligation
to make payments to is that of a debtor only.
33.8. Notices.
Except as required herein, all notices, consents, approvals and other communications hereunder, including the commencement or subsequent
communications pertaining to any arbitration or other legal proceeding arising hereunder (each, a “Notice”) shall be
in writing and shall be deemed to have been received only if and on the first business day after received (i) by personal delivery, (ii)
from an internationally recognized expedited courier service such as Federal Express, DHL or UPS, or (iii) as an “in the window”
email or a PDF attachment to an email, provided, however, that receipt of the email either is confirmed by an automatically generated
“read” receipt or by a return email from the recipient, or if the
Globestar-SMIHC Collaboration Agreement (09-26-2023) Final.docx |
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foregoing does not occur, the sender of the Notice
also sends a copy by regular mail posted in the United States, or personal delivery, or by an internationally recognized expedited courier
service such as Federal Express or UPS. Notwithstanding the foregoing, unless a Party in writing consents otherwise, all Notices are effective
only if also provided by email. Unless a Party notifies the other Parties of new Notice information, the Notice information is set forth
in the introductory paragraph to this Agreement. Required copies of each Notice shall concurrently be sent by email to ________.
33.9. Governing
Law. This Agreement will be governed by, and construed in accordance with, the substantive Rules of the State of California, USA without
giving effect to any choice or conflict of law provision, except that questions affecting the construction and effect of any patent, copyright
or trademark shall be determined by the Rules of the country in which the patent, copyright or trademark shall have been granted.
33.10. Costs
relating to this Agreement. GTC shall be responsible for and shall pay all legal and accounting fees in connection with the drafting
and negotiation of this Agreement.
33.11. Severability.
If an arbitrator or other tribunal of competent jurisdiction holds any provision of this Agreement to be illegal, unenforceable or
invalid in whole or in part for any reason: (i) such provision shall be in good faith adjusted rather than voided, if possible, to achieve
the intent of the Parties, (ii) this Agreement shall be read as if the invalid, illegal or unenforceable words or provisions had to that
extent been deleted, and (iii) the validity and enforceability of the remainder of this Agreement shall not be affected thereby unless
an essential purpose of this Agreement would be defeated by the loss of the illegal, unenforceable, or invalid provisions.
33.12. Entire
Agreement. This Agreement expresses the complete and entire understanding of the Parties with respect to the subject matter hereof
and supersedes and merges all prior and contemporaneous agreements, dealings, negotiations, promises, representations and communications
regarding its subject matter (whether written or oral), between the Parties relating to the subject matter hereof other than the other
agreements referenced herein. There are no representations, warranties or other agreements between the Parties (whether express or implied)
in connection with the subject matter of this Agreement except as specifically set forth herein.
33.13. Waiver;
Modifications. No provision may be modified, amended or waived, and no Party’s rights or remedies be waived, except by a writing
executed by authorized representatives of the Parties. Under no circumstance or conditions shall any other conduct be relied upon by the
Parties.
33.14. Counterparts
and Signature Validity. This Agreement may be executed in several counterparts and all counterparts so executed shall constitute one
agreement that is binding on all Parties, notwithstanding that all Parties are not signatories to the original or the same counterpart.
PDF signatures that are electronically transmitted shall be acceptable as if original signatures had been exchanged.
34. Novation:
After formation of IndiaCo, IndiaCo will sign a joinder agreement pursuant to which IndiaCo will become a Party to this Agreement
on all of the terms and conditions set forth herein, including permitting execution in counterparts. Upon delivery of the Joinder Agreement
to GlobeStar, Soma and SMIHC: (i) SMIHC, GlobeStar and Soma will execute and return a fully-executed copy of the Joinder Agreement; and
(ii) provided only that SMIHC executes the Joinder Agreement and regardless of whether GlobeStar or Soma do so, SMIHC shall be relieved
of any liability or responsibility for the representations, warranties, covenants, performance and omissions of IndiaCo whether pursuant
to this Agreement or otherwise.
[Signatures on Next Page]
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IN WITNESS WHEREOF,
the Parties have caused this Agreement to be executed by their duly authorized representatives as of the Effective
Date.
GlobeStar Therapeutics Inc.: |
SMI HealthCare LLC: |
|
|
|
By: Spivak Management Inc., Manager |
By: /s/ James C. Katzaroff |
|
James C. Katzaroff, Chief Executive Officer |
|
|
By: /s/ Kenin M. Spivak |
|
Kenin M. Spivak, President |
|
|
SomaCeuticals, Inc. |
IndiaCo, in formation:* |
|
|
|
|
By: /s/ James C. Katzaroff |
By: /s/ Shekar Tirumalai |
James C. Katzaroff, Chief Executive Officer |
Shekar Tirumalai, Managing Director-designate |
* This signature to be replaced
by Joinder Agreement from IndiaCo after its formation.
Globestar-SMIHC Collaboration Agreement (09-26-2023) Final.docx |
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APPENDIX A: PATENT RIGHTS
(Dates are in month/day/year format)
Application No. |
Patent
No. |
Country |
Filing Date |
Issue Date |
Priority |
Applicant |
Title |
14/793,970 |
|
US |
07/08/2015 |
04/07/2020 |
PCT/IT2014/000207 |
De
Silvestri,
Fabrizio |
TREATMENT OF MULTIPLE SCLEROSIS |
14/429,097 |
|
US |
08/08/2014 |
|
PCT/IT2014/000207 |
De
Silvestri,
Fabrizio |
USE IN SINGLE
PILL/TABLET/CAPS
ULE OF
MINOCYCLINE,
FLUCONAZOLE
AND
ATORVASTATIN IN
THE TREATMENT
OF MULTIPLE
SCLEROSIS |
EP14790741 A |
|
EP |
08/06/2014 |
|
ITTR2014A000003A
(08/04/2014) |
De
Silvestri,
Fabrizio |
USE IN SINGLE
PILL/TABLET/CAPS
ULE OF
MINOCYCLINE,
FLUCONAZOLE
AND
ATORVASTATIN IN
THE TREATMENT
OF MULTIPLE
SCLEROSIS |
PCT/IT2014
/000207 |
|
IT |
08/06/2014 |
|
TR2014A000003
(08/04/2014) |
De
Silvestri,
Fabrizio |
USE IN SINGLE
PILL/TABLET/CAPS
ULE OF
MINOCYCLINE,
FLUCONAZOLE
AND
ATORVASTATIN IN
THE TREATMENT
OF MULTIPLE
SCLEROSIS |
2017506830 |
|
JP |
08/06/2014 |
|
|
1) Decyl
**** and
Fabrizio,
2)
MIYOSHI,
Hidekazu, |
Use of a single pill
/ tablet / capsule of
minocycline,
fluconazole and
atorvastatin in the
treatment of
multiple sclerosis. |
Globestar-SMIHC Collaboration Agreement (09-26-2023) Final.docx |
Page 43 of 62 |
|
|
|
|
|
|
3) ITO,
Masakazu,
4) HARA,
Yuko, |
|
201700051 |
|
EA |
08/06/2014 |
|
|
|
|
2958057 |
|
CA |
08/06/2014 |
|
|
De
Silvestri,
Fabrizio |
USE IN SINGLE
PILL/TABLET/CAPS
ULE
MINOCYCLINE,
FLUCONAZOLE
AND
ATORVASTATIN IN
THE TREATMENT
OF AUTOIMMUNE
DISEASES OF TYPE
RELAPSING
REMITTING
MULTIPLE
SCLEROSIS OR
PROGRESSIVE
AIMED AT
IMPROVING THE
QUALITY 'OF LIFE
AND CONTEXT OF
DISABILITY SCALE
EDSS |
2014800812
76 |
|
CN |
08/06/2014 |
|
|
De
Silvestri,
Fabrizio |
Use of a single pill
/ tablet / capsule
of minocycline,
fluconazole and
atorvastatin in the
treatment of
multiple sclerosis |
2014403312 |
|
AU |
08/06/2014 |
|
|
De
Silvestri,
Fabrizio |
Use of a single pill
/ tablet / capsule
of minocycline,
fluconazole and
atorvastatin in the
treatment of
multiple sclerosis |
25041917 |
|
IL |
02/02/2017 |
|
|
|
|
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APPENDIX B: Territory
(Countries that presently are not members of
the African Union)**
1 |
India |
2 |
Bahrain |
3 |
Bangladesh * |
4 |
Bhutan * |
5 |
Brunei |
6 |
Indonesia |
7 |
Jordan |
8 |
Kuwait |
9 |
Lebanon |
10 |
Malaysia |
11 |
Mauritius * |
12 |
Nepal * |
13 |
Oman |
14 |
Pakistan * |
15 |
Philippines * |
16 |
Qatar |
17 |
Saudi Arabia |
18 |
Singapore |
19 |
Sri Lanka * |
20 |
Thailand * |
21 |
Turkey |
22 |
United Arab Emirates |
23 |
Vietnam |
(Members of the African Union) **
1 |
Burkina Faso |
2 |
Federal Republic of Nigeria |
3 |
Kingdom of Eswatini |
4 |
Kingdom of Lesotho |
5 |
Republic of Angola |
6 |
Republic of Benin |
7 |
Republic of Botswana |
8 |
Republic of Cabo Verde |
9 |
Republic of Côte d’Ivoire |
10 |
Republic of Ghana |
11 |
Republic of Guinea |
12 |
Republic of Guinea-Bissau |
13 |
Republic of Liberia |
14 |
Republic of Malawi |
15 |
Republic of Mali |
16 |
Republic of Mozambique |
17 |
Republic of Namibia |
18 |
Republic of Niger |
19 |
Republic of Senegal |
20 |
Republic of Sierra Leone |
21 |
Republic of South Africa |
22 |
Republic of the Gambia |
23 |
Republic of Zambia |
Globestar-SMIHC Collaboration Agreement (09-26-2023) Final.docx |
Page 45 of 62 |
24 |
Republic of Zimbabwe |
25 |
Togolese Republic |
26 |
Arab Republic of Egypt |
27 |
Central African Republic |
28 |
Democratic Republic of Congo |
29 |
Democratic Republic of São Tomé and Príncipe |
30 |
Federal Democratic Republic of Ethiopia |
31 |
Federal Republic of Somalia |
32 |
Gabonese Republic |
33 |
Islamic Republic of Mauritania |
34 |
Kingdom of Morocco |
35 |
Libya |
36 |
People’s Democratic Republic of Algeria |
37 |
Republic of Burundi |
38 |
Republic of Cameroon |
39 |
Republic of Chad |
40 |
Republic of Djibouti |
41 |
Republic of Equatorial Guinea |
42 |
Republic of Kenya |
43 |
Republic of Madagascar |
44 |
Republic of Mauritius |
45 |
Republic of Rwanda |
46 |
Republic of Seychelles |
47 |
Republic of South Sudan |
48 |
Republic of the Congo |
49 |
Republic of the Sudan |
50 |
Republic of Tunisia |
51 |
Republic of Uganda |
52 |
Sahrawi Arab Democratic Republic |
53 |
State of Eritrea |
54 |
Union of the Comoros |
55 |
United Republic of Tanzania |
* Regulatory approval in India
may clear most regulatory requirements for manufacture, sale and distribution of products in this country.
** The Parties acknowledge that
there is little data on the potential for Licensed Products in some of these countries, particularly many of the African Union member
countries, and that the introduction of Licensed Products in those countries for which the opportunity is uncertain, or smaller than other
countries, likely will be delayed until sales and distribution are stabilized in more promising countries.
# # #
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APPENDIX 2.4: GTC Products
Globestar is planning a specific formulation of the three
drugs listed below:
Minocycline
An oral tetracycline antibiotic. Used to treat
bacterial infections including respiratory and urinary tract infections. The drug is currently being studied for relapsing-remitting multiple
sclerosis (RRMS) or clinically isolated syndrome (CIS), referring to the first episode of neurologic symptoms that last at least 24-hours
and are caused by myelin damage.
Fluconazole
An triazole antifungal. Used to prevent and treat a variety
of fungal and yeast infections by stopping the growth of certain types of fungus. Studies using a combination of Minocycline &
Fluconazole against candida albicans fungal growths proven effective, in vitro.
Atorvastatin
A Statin, HMG CoA reductase inhibitor. Commonly
used to lower blood levels of LDL cholesterol, increase levels of HDL cholesterol and to lower triglycerides. It is also an effective
immunomodulatory agent shown to prevent autoimmune encephalomyelitis in animal model studies.
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APPENDIX 5.2.1: PHASE A SERVICES
WORK ORDER
Unless expressly stated otherwise, terms defined in the
main portion of this Agreement have the same meanings in this Appendix.
I. SERVICES*
* Distribution is not an IndiaCo Service,
will be arranged by IndiaCo as described in this Agreement. Sales and Distribution is not an IndiaCo Service and will be arranged by IndiaCo
as described in this Agreement.
Activity |
Start |
End |
Dependency |
Responsible |
A. Formation Services
|
Identify Tax Counsel |
Week 1 |
Week 2 |
Complete FS Deposit |
IndiaCo and GTC |
Establishing India-LocalCo
a. Identifying and appointing Corporate Secretary
b. Directors
Registration and securing ID Numbers
c. ROC
Submission
d. Regd.
Office and related contracts.
e. Tax
ID
f. GST
ID
g. Appointing
Legal Counsel |
Week 2 |
Week 5 |
Advice of Tax Counsel; Information from GTC |
IndiaCo and professionals |
Accounting, infrastructure, and
banking
a. Identify
and appoint auditor.
b. Opening
of Bank accounts
|
Week 4
Week 4 |
Week 6
Week 6 |
Post India LocalCo incorporation and receipt of Incorp Certificate |
IndiaCo and professionals |
Continuing maintenance activities |
Remainder of year |
Formation of India LocalCo |
IndiaCo and professionals |
B. Remaining Phase A Services
|
Form IndiaCo |
Week 1 |
Week 4 |
Complete FS Deposit |
India Co |
Identification of Staff and Advisors |
Week 1 |
Week 6 |
|
IndiaCo |
Identification of a CRM system |
Week 4 |
Week 6 |
|
IndiaCo |
Communication |
Week 4 |
Week 7 |
Information from GTC |
IndiaCo |
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a. Internal
Protocols and
formats (IndiaCo to GTC)
Clinical Trial related updates |
Week 14 |
Ongoing |
|
|
Clinical Trial Registration
a. Preparation
of Company and Product Documentation for submission
b. Submission
for regulatory
registration and acceptance
a. DCGI
b. ICMR
c. CDSCO
|
Week 6
Week 8 |
Week 12
Week 12 |
Complete Phase A
Deposit |
IndiaCo with third party professionals |
Completion of License and Approval Process |
|
Week 14 |
Information from GTC |
IndiaCo and Third party agent |
Identify Medical Institution(s)
a. Recommend
full list to GTC
for selection and approval.
b. Recommend
shortlist
Medical Institution(s) for
clinical trials.
c. Identify
and contract with
government approved trial
agencies.
d. Basis
(b) above to engage in
discussions with Medical
Institution(s) for CT process
and costs.
e. Finalize Medical Institution(s)
and contractual process
f. Recommend
specific MS
related patient groups to
GTC for decision making on
individual trials.
|
Week 1
Week 3
Week 5
Week 9
Week 9
Week 14 |
Week 3
Week 4
Week 8
Week 13
Week 13
Week 20 |
Information from GTC |
IndiaCo with inputs from GTC
Negotiations with input
from SMIHC |
Negotiate and finalize phases for trials and reporting process to India-LocalCo and Authorities enable effective market authorization. |
Week 20 |
Week 24 |
Receipt of all approvals from regulatory bodies and federal agencies to conduct trials with the stated Medical Institution; Information from GTC |
IndiaCo and SMIHC |
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Page 49 of 62 |
Territory List and LocalCos
a. Identify
sequence of
territories for product
distribution.
b. Plan to list activities to enable
timely entry to the stated
territories.
c. List
local regulatory and
statutory requirements to be
complied with for sales and
marketing.
d. Management
Service Agreements with Local Co’s |
Week 20
Week 24
Week 24
Week 24 |
Week 24
Ongoing
to Phase
2
Ongoing
to Phase
2
Ongoing
to Phase
2 |
|
IndiaCo with input from SMIHC |
Identify Mfg. options -India.
a. List
of options for initial pre-
clinical trial manufacturing
b. List
of options for long term
manufacturing (post
regulatory approvals)
c. Territory based requirements
and options for distribution
from India or local
manufacturing. |
Week 14
Week 14
Week 24 |
Week 20
Week 20
Week 30 |
Information from GTC |
IndiaCo |
Distribution Network identification by
location |
Week 26 |
Week 34 |
|
IndiaCo |
Communication with potential
medical facilities and medical
practitioners to use the approved
product |
Week 30 |
Ongoing |
Trial initiation; Information from GTC |
IndiaCo |
Obtain regulatory approvals in India
required to market, sell and distribute
GTC Products in India |
Week 36 |
Ongoing |
Results of Clinical Trial |
IndiaCo and professionals |
With GTC, develop a preliminary plan
for additional Clinical Trials |
Week 48 |
Week 52 |
Information from GTC |
|
Project Management Responsibilities, generally
● |
Creating, maintaining, executing, and monitoring project plans |
● |
Identifying and mitigating project risks and issues |
● |
Developing, reviewing, authorizing, implementing, and managing Change Orders |
● |
Managing assigned personnel according to the defined scope of the project |
● |
Approving the requirements, timetable, personnel and budget |
● |
Arranging the provision of funds from Deposit and of personnel |
● |
Ensuring that major business risks are identified |
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● |
Ensuring business / operational support arrangements are put in place |
II. BUDGET
*
* Budgets do not
include SMIG Management Fees, GTC travel costs or any other legal, or accounting fees incurred by GTC (including fees for tax or corporate
legal advice on the structure), Clinical Trial costs, manufacturing costs, or litigation.
A. Phase A - Formation Services |
|
|
|
|
|
USD |
|
Company Incorporation |
|
|
Authorized capital (minimum) |
|
$1,220 |
ROC Filing fees |
|
$122 |
Consultant fee |
|
$1,829 |
Corporate misc. expenses |
|
$7,500 |
Sub-total |
|
$10,671 |
|
|
|
|
Corporate Maintenance Costs |
|
|
|
Admin staff |
|
$3,659 |
|
General and admin costs |
|
$3,659 |
Office rent |
|
$9,000 |
Travel, Entertainment |
|
$1,000 |
Audit, Compliance and Accounting |
|
$3,800 |
Sub-total |
|
$21,117 |
|
|
|
Total Formation Services, before Contingency |
|
$31,788 |
Contingency (20%) |
|
$6,358 |
Total Formation Services |
|
$38,145 |
|
|
|
B. Remaining Phase A Services |
|
|
|
|
USD |
IndiaCo Formation Costs |
|
$10,671 |
|
Regulatory Drug Registration process |
|
$43,165 |
|
Regulatory Process Consultant |
|
$18,293 |
|
Initial Clinical Trial Registration process and Licenses |
|
$78,354 |
|
Legal Fees |
|
$45,000 |
|
Travel Costs |
|
$20,000 |
|
GST/FEMA/other Compliances |
|
$28,293 |
|
Total Remaining Services, before Contingency |
|
$243,774 |
|
Contingency (20%) |
|
$48,755 |
|
Total Phase A Remaining Services |
|
$292,529 |
|
III. REPORTS
See Appendix 5.4.
Globestar-SMIHC Collaboration Agreement (09-26-2023) Final.docx |
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IV. COMPENSATION
See main portion of Agreement.
V. DEPOSIT
See Section 16 and other provisions of main portion of
Agreement.
VI. VARIANCES
FROM MAIN PORTION OF AGREEMENT
None.
VII. OTHER
None.
-
END APPENDIX 5.2.1 -
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APPENDIX 5.2.2: PHASE B SERVICES WORK ORDER
Unless expressly stated otherwise, terms defined in the
main portion of this Agreement have the same meanings in this Appendix.
I. SERVICES*
* Distribution is not an IndiaCo Service,
will be arranged by IndiaCo as described in this Agreement. Sales and Distribution is not an IndiaCo Service and will be arranged by IndiaCo
as described in this Agreement.
A. First
Year of Phase B
Activity |
Start |
End |
Dependency |
Responsible |
Develop full budget for First Year of Phase B for India |
Week 1 |
Week 6 |
Phase B Deposit |
IndiaCo with Input from SMIHC |
Market Initiation for Sale in India
a. Manufacturing
Options to be
shortlisted
b. Distribution
Network to be
identified for India distribution
and possibly for territories in the
region
c. Pricing
mechanism for India
d. Marketing
strategy
a. Institutions
b. Practitioners
c. Patients
d. Government
Bodies and
Hospitals
e. Insurance
Industry
f. Pharma
Industry
e. Sales |
End of Phase 3 of clinical trials |
End of Clinical Trials |
Receipt of
Market Authorization; Information from GTC |
IndiaCo |
Regulatory and Statutory in India
a. Establish
ongoing process for
additional trials.
a. Territory
based
b. For
regulatory approvals of other countries
where this Clinical Trial
is accepted |
Week 4 |
Ongoing |
Post Clinical Trial; Information from GTC |
IndiaCo |
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b. Relationship management with concerned institutions and statutory bodies.
c. Compliance
Reporting
a. India
b. FDA
c. Territory
wise as required |
|
|
|
|
Intellectual Property in India
a. Rights
protection process to be fully implemented.
b. Filings
for key Intellectual Property Rights in India. |
Week 4 |
Week 12 |
Information from GTC |
IndiaCo and lawyers |
Manufacturing for India
a. Develop
a plan basis regional
volume of sales for
manufacturing in India
b. Evaluate
suitable manufacturers
c. Shortlist
Options for
a. Commercial
production
b. Local
and Territory wise
pack management
capability
c. Pricing
d. Territory
based
requirements and
options for manufacture
from India or local
manufacturing.
d. Negotiate
with manufacturers
per ( c)
e. Obtain
factory and final
production licenses and
approvals required for
manufacturing in India.
Licensing and approvals for India
manufacturing and LocalCos in Territory
to be obtained |
Week 1
Week 4 |
Week 4
Week 8 |
Post Year 1 Phase B; Information from GTC |
IndiaCo and professionals |
Advisory Board |
Week 4 |
Week 10 |
Information from GTC |
IndiaCo |
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a. Form Advisory Board and
appoint members from industry
and institutions |
|
|
|
|
Additional Clinical Trials in India
a. Identify
need
b. Create project plan and schedule
for the same
c. Creating,
maintaining, and monitoring schedule of delivery
d. Identifying
and mitigating project risks and issues
e. Approving
the requirements, timetable, personnel and budget
Authorizing the provision of funds
/personnel (internal or external
f. Provide
the same services as for the Initial Clinical Trial |
|
Ongoing until additional trial data acceptable |
|
IndiaCo and Medical Institutions |
Develop plan and preliminary timeline
for countries of
the Territory.
a. Regulatory
Approvals
b. Intellectual
Property Rights
c. Clinical
Trials, if any
d. Local
Sale Process
e. Additional
Trials required or not .
if yes, process for the same
f. Manufacturing
Options in Territory countries.
i. Evaluation
of options
ii. Costing
iii. Licenses
and Approvals
iv. Timelines
v. IP
rights
g. Marketing
and Sub licensing
i. Options
to market and distribution under options available
ii. Develop
and implement plans per (i) above.
iii. Legal
Contracts and enforceability |
Week 20 |
Week 40 |
Post Year 1 Phase B; ; Information from GTC |
IndiaCo & GTC |
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Develop full budget by the end of year
one, for the Second Year of Phase B |
Week 36 |
Week 40 |
Post month 6 of Year 1 Ph B |
IndiaCo |
Project Management Responsibilities, generally
● |
Creating, maintaining, executing, and monitoring project plans |
● |
Identifying and mitigating project risks and issues |
● |
Developing, reviewing, authorizing, implementing, and managing Change Orders |
● |
Managing assigned personnel according to the defined scope of the project |
● |
Approving the requirements, timetable, personnel and budget |
● |
Arranging the provision of funds from Deposit and of personnel |
● |
Ensuring that major business risks are identified |
● |
Ensuring business / operational support arrangements are put in place |
B. Continuing
Activities During Phase 2
1. |
Identify, select, negotiate with, implement and monitor additional Clinical Trials. |
|
|
2. |
Maintain regulatory relationships, compliance, renewals and other approvals in in Territory. |
|
|
3. |
Continue Intellectual Property Rights filings and maintenance in India. |
|
|
4. |
Implement plan for Intellectual Property protections in remainder of Territory. |
|
|
5. |
Work with advisory board and as necessary recruit additional or replacement members. |
|
|
6. |
Continue to implement Manufacturing Plan, including identification, selection, and negotiations with potential additional or replacement manufacturers. |
|
|
7. |
Continue to evolve and implement marketing, sales and distribution plan, with a phased roll out among countries in the Territory and other SMIG customers (certain of these activities are not IndiaCo Services) |
II. BUDGET
*
* Budgets do not include SMIG
Management Fees, GTC travel costs or any other legal, or accounting fees incurred by GTC (including fees for tax or corporate legal advice
on the structure, Clinical Trial costs, manufacturing costs, or litigation.
Phase B - Year 1
|
USD |
Corporate Maintenance |
|
Corporate Misc. Expenses |
$7,500 |
Admin Staff |
$14,634 |
General and Admin Costs |
$14,634 |
Office Rent |
$12,000 |
Travel, Entertainment |
$36,000 |
Audit, Compliance and Accounting |
$24,000 |
Sub-total |
$108,768 |
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Regulatory |
|
Regulatory Process Consultant |
$36,000 |
Clinical Trials Registration Process and Licenses |
$75,000 |
Clinical Trials Patient dose & Phase wise management |
$80,000 |
Commercial Approval and Market Authorization |
$72,000 |
R&D Filing and Reporting |
$28,000 |
Legal Fees |
$51,000 |
GST/FEMA/other Compliances |
$28,293 |
Sub-total |
$370,293 |
|
|
Advisory Board |
|
Neurologist |
$36,000 |
Senior Pharma Industry Professional/Leader |
$36,000 |
Drugs Controller General of India |
$36,000 |
Strategy consultant/Consulting expert |
$36,000 |
Sub-total |
$144,000 |
|
|
Sales |
|
Sales Personnel - General |
$27,000 |
Patient Sales Personnel |
$13,500 |
Hospital Sales |
$60,000 |
Travel, Entertainment, Collateral material |
$25,000 |
Marketing and Business Development |
$0 |
Sub-total |
$125,500 |
|
|
Total Phase B-Year 1, before Contingency |
$748,561 |
Contingency (20%) |
$149,712 |
Total Phase B-Year 1 |
$898,274 |
III. REPORTS
See Appendix 5.4.
IV. COMPENSATION
See main portion of Agreement.
I. DEPOSIT
See Section 16 and other provisions of main portion of
Agreement.
II. VARIANCES
FROM MAIN PORTION OF AGREEMENT
None.
Globestar-SMIHC Collaboration Agreement (09-26-2023) Final.docx |
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V. OTHER
None.
-
END APPENDIX 5.2.2 -
Globestar-SMIHC Collaboration Agreement (09-26-2023) Final.docx |
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APPENDIX 5.4: REPORTS
Unless expressly stated otherwise, terms defined in
the main portion of this Agreement have the same meanings in this Appendix.
In addition to financial reports and accounting information
provided for in the main portion of this Agreement, the following reports will be provided as appropriate to the activities then being
undertaken:
Phase |
Activity |
Reports to GTC |
A |
Developmental Plan
monitoring roles and
responsibilities |
Outlines the roles and responsibilities of
project participants
in the review, approval
and dissemination of information about
key project processes, events, and
documents.
Frequency: Approximately Week 8. To be
revised
and updated prior to beginning of
Phase B |
A |
Company Incorporation |
Procedure and process report for
incorporation (pre-
registration)
Completion report with copy of all
certificates and details (post registration)
Frequency: Approximately Week 8 with
periodic
updates |
A |
Identify medical institution(s)
to participate in Initial Clinical
Trial, potentially including
Apollo. |
List of Institutions, their clinical trial
process, phase
wise schedule
Regulatory performance and compliance
process
Frequency: Approximately monthly from
Week 8 to
start of Initial Clinical Trial |
A |
Accounting, Banking and
Expense Reports |
Quarterly; if possible, on-line access for
LocalCo accounts. |
A |
Subject to GTC approval of
potential medical institution(s)
to participate in Clinical Trial(s), with GTC’s assistance,
engage in discussions and
thereafter negotiations for a
Clinical Trial. |
Comparative statements including
financial, process,
regulatory approval,
licensing impact reports and documents
to be submitted
Frequency: As necessary |
A |
Monitor Clinical Trial(s) and
act as local representative for
GTC |
Activity Reports (may be generated by
Institution, with
any comments from
IndiaCo)
Frequency: Monthly. As per ICMR and
DCGI standard
reporting formats. |
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A |
Preliminarily identify
manufacturing options and
costs to support budgeting for
Phase B. |
List of manufacturing options and costs to be submitted.
Frequency: As necessary. |
A |
Develop a preliminary budget
for Phase B. |
Financial plan
Frequency: by approximately Week 24 of Phase A |
B |
With assistance of medical
institution(s) involved in the
Clinical Trial, obtain all
regulatory approvals in India
required to market, sell and
distribute GTC Products |
Quarterly status reports |
B
|
Intellectual Property Rights |
Quarterly status reports |
B |
Project Tracking Log (to be
generated by medical
institution, with comments
from IndiaCo) |
Clinical Trial Protocols report
Protocol Documents
Calendar mapping with phases report
Threaded Document progress report
Archiving trial data report per Clinical Trial
Frequency: Quarterly and earlier if exceptions
are reported. |
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APPENDIX 9.3.1A, PATENT ASSIGNMENT
WHEREAS, the following party:
|
Name |
Location |
|
|
|
|
Fabrizio De Silvestri |
Terni, Italy |
hereinafter referred to as ASSIGNOR, is the inventor
of the following patent:
|
Patent Number: |
10,610,592 |
|
|
|
|
Issue Date: |
Apr. 7, 2020 |
|
|
|
|
Title: |
TREATMENT OF MULTIPLE SCLEROSIS |
WHEREAS, 7 to Stand, Corp., having
its principal office at P.O. Box 273, Bronxville, New York 10708, hereinafter referred to as ASSIGNEE, is desirous of acquiring ASSIGNOR’S
interest in and to said patent and any foreign patents which are related to the same.
NOW, THEREFORE, TO ALL WHOM IT
MAY CONCERN: Be it known that, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged by ASSIGNOR,
ASSIGNOR has sold, assigned, and transferred and does hereby sell, assign, and transfer unto ASSIGNEE, and ASSIGNEE’S successors
and assigns, (a) the entire right, title and interest, for the United States of America, in and to said patent and all the rights and
privileges in any application and under any and all patents that may be granted in the U.S. from said patent, including all corresponding
continuation, continuation-in-part, divisional, reissue, and reexamination applications; and (b) the entire right, title and interest
in and to any foreign patents related to said US patent for all countries foreign to the U.S., including all rights of priority arising
from them, and all the rights and privileges under any and all forms of protection, including patents, that may be granted in said countries
foreign to the U.S. for them.
ASSIGNOR authorizes ASSIGNEE to
make application for such protection in its own name and maintain such protection in any and all countries foreign to the U.S., and to
invoke and claim for any application for patent or other form of protection for said invention(s), without further authorization from
ASSIGNOR, any and all benefits, including the right of priority provided by any and all treaties, conventions, or agreements.
ASSIGNOR agrees to execute all
instruments and documents required for the making and prosecution of the identified patent applications (and derivatives) for litigation
regarding letters patent derived therefrom, and for the purpose of protecting and perfecting title to the identified patent application
(and derivatives).
Assignor:
_______________________________________ Date:
January 27, 2021
Fabrizio De Silvestri
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APPENDIX 9.3.1B: Confirmatory Grant of Exclusive
License
The following parties have entered
into an exclusive license agreement (“Agreement”) for the following patent as of August 21st, 2020 (the “Effective
Date”) by and between 7 to Stand, Corp., a Delaware corporation, having its principal office at P.O. Box 273, Bronxville, New York
10708 (hereinafter “Stand” or “Licensor”) and SomaCeuticals, Inc., a Texas company having its principal office
at 2500 Wilcrest Drive, Suite 300, Houston, Texas 77042 (hereinafter “Soma” or “Licensee”).
Stand has licensed the following
patent to Soma on an exclusive basis:
|
Patent Number: |
10,610,592 |
|
|
|
|
Issue Date: |
April 7, 2020 |
|
|
|
|
Title: |
TREATMENT OF MULTIPLE SCLEROSIS |
|
|
|
|
Inventor: |
Fabrizio De Silvestri |
The exclusive license covers all
of the rights that derive from the patent, as well as the rights to sublicense the patent, prosecute the patent, and enforce the patent.
SomaCeuticals, Inc. |
|
7 to Stand, Corp. |
|
|
|
|
|
By: |
________________________ |
|
By |
________________________ |
|
James C. Katzaroff |
|
|
Christian G. Fassetta |
|
President |
|
|
Authorized representative |
|
Date: Jan. 27, 2021 |
|
|
Date: Jan. 27, 2021 |
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