Exhibit
10.1
LICENSE
AGREEMENT
This
LICENSE AGREEMENT (the “Agreement”), made and effective as of July 18, 2022 (the “Effective Date”),
is by and between ProPhase BioPharma, Inc. (“ProPhase”), a corporation organized and existing under the laws of the
State of Delaware, having its principal office at 711 Stewart Ave, Suite 200, Garden City, NY, 11530 and Global BioLife, Inc. (“Global
BioLife” or “Licensor”), a corporation organized and existing under the laws of the State of Nevada, having
its principal office at 1400 Broadfield Blvd., Suite 100, Houston, Texas 77084. Each of ProPhase and Licensor are referred to herein
as a “Party” and collectively as the “Parties.”
RECITALS
WHEREAS,
Licensor owns certain intellectual property rights directed to the Licensed Compound (as defined below); and
WHEREAS,
ProPhase wishes to obtain, and Licensor wishes to grant, a license to these certain intellectual property rights of Licensor for the
purpose of Exploiting (as defined below) the Licensed Compound and Licensed Products (as defined below).
NOW,
THEREFORE, in consideration of the mutual promises and agreements contained herein, the Parties hereby agree as follows:
1. DEFINITIONS.
Whenever
used in this Agreement, the following terms shall have the following meanings:
1.01 “Action”
has the meaning set forth in Section 8.02.
1.02 “Affiliate”
means any company or other legal entity in which a Party holds at least fifty percent (50%) of (i) the capital or (ii) the voting rights
..
1.03 “Agreement”
has the meaning set forth in the introductory paragraph.
1.04 “Calendar
Year” means any consecutive period of twelve months commencing on the first day of January of any year.
1.05 “Clinical
Trial” means a Phase 1 Study, a Phase 2 Study, a Phase 3 Study, a Phase 4 Study, or a combination of two (2) or more of any
of the foregoing studies.
1.06 “Combination
Product” means a Licensed Product that is comprised of or contains Licensed Compound as an active ingredient together with
one (1) or more different active ingredients, whether in the same or different formulations and is sold either (i) as a fixed dose unit
at a single price, or (ii) sold in separate doses as one (1) product.
1.07 “Commercially
Reasonable Efforts” means, with respect to ProPhase’s obligations under Section 5.01, the carrying out of such
obligations by ProPhase using efforts and resources comparable to the efforts and resources that ProPhase would typically devote to a
product of similar market potential at a similar stage of in development or product life, taking into consideration all relevant scientific,
commercial, and other factors that ProPhase would take into account, including, without limitation, issues of safety and efficacy, expected
and actual product labelling, expected and actual time to develop, the nature and extent of expected and actual market exclusivity (including
Patent coverage), expected and actual profitability (including royalties and other payments required hereunder), expected and actual
competitiveness of alternative products, and the expected and actual amounts of marketing and promotional expenditures required.
1.08 “Infringing
Product” has the meaning set forth in Section 8.02.
1.09 “Confidential
Information” means (a) all confidential or proprietary information relating to the Licensed Compound and Licensed Products,
and (b) all other confidential or proprietary documents, technology, Know-How, or other information (whether or not patentable) actually
disclosed by or on behalf of one Party to the other or its representatives pursuant to this Agreement.
1.10 “Control”
or “Controlled” means, with respect to any (a) material, document, item of information, method, data, or other Know-How,
or (b) Patent Rights or other Intellectual Property Rights, the possession by a Party or its Affiliates, whether by ownership or license
(other than by licenses granted under this Agreement), of the ability to grant to the other Party access, a license and/or a sublicense
as provided herein without requiring the consent of a Third Party or violating the terms of any agreement or other arrangement with any
Third Party, in each case as of the Effective Date, or if any of the same are acquired or created after the Effective Date, at the date
it is acquired or created by the relevant Party or its Affiliate.
1.11 “Commercialization”
or “Commercialize” means any activities directed to obtaining Pricing and Reimbursement Approval, marketing, promoting,
distributing, importing, exporting, Detailing, offering to sell, and/or selling a Licensed Product (including establishing the price
for such product).
1.12 “Cover”,
“Covering”, or “Covered” means, with respect to a Licensed Product, the Exploitation of or manufacturing
of the Licensed Product, is encompassed within a valid claim of one or more Licensed Patents (or, in the case of an application that
that has not yet issued, would infringe a claim of the application if it were to issue as a patent.
1.13 “Date
of First Commercial Sale” means the date on which a Licensed Product is first sold for monetary value for use or consumption
by the end user of such Licensed Product by ProPhase, its Affiliate or its Sublicensee.
1.14 “Development”
or “Develop” means, with respect to the Licensed Compound and Licensed Product, those activities necessary or useful
for research and development, including: preclinical and clinical drug development activities, the conduct of Clinical Trials, test method
development and stability testing, toxicology, formulation, and delivery system development, process development, pre-clinical and clinical
Licensed Compound and Licensed Product supply, manufacturing scale-up, development-stage manufacturing, quality assurance/quality control
procedure development, and performance with respect to clinical materials, statistical analysis, and report writing, and clinical studies,
and regulatory affairs. When used as a verb, “Develop” means to engage in Development.
1.15 “Disclosing
Party” means, with respect to Confidential Information, Patent Rights, or Know-How, the Party that owns or Controls such Confidential
Information, Patent Rights, or Know-How.
1.16 “Effective
Date” has the meaning set forth in the introductory paragraph.
1.17 “Exploit”
“Exploiting”, or “Exploitation” would mean to make, have made, import, use, sell, or offer for
sale, including to research, develop, Commercialize, register, modify, enhance, improve, manufacture, have manufactured, hold or keep
(whether for disposal or otherwise), formulate, optimize, have used, export, transport, distribute, promote, market, have sold or otherwise
dispose of.
1.18 “FDA”
means the United States Food and Drug Administration and any successor agency(ies) or authority having substantially the same function.
1.19 “Field”
means all uses limited to modified phenolic compounds relating to the treatment of cancer, inflammatory diseases or symptoms, memory-related
syndromes, diseases or symptoms, including dementia and Alzheimer’s Disease.
1.20 “GRDG”
means GRDG Sciences, LLC, a company organized in the state of Florida with a principal business office address of 234 W. Central Ave.,
Winter Haven, Florida 33880
1.21 “IND”
means an Investigational New Drug Application filed with the FDA under 21 C.F.R. Part 312 or similar non-United States application or
submission in any country or group of countries for permission to conduct human clinical investigations, including all supplements, amendments,
variations, extensions, and renewals thereof that may be filed with respect to the foregoing.
1.22 “Indemnitees”
has the meaning set forth in Section 9.02.
1.23 “Indemnitor”
has the meaning set forth in Section 9.03.
1.24 “Intellectual
Property Rights” means: (a) Know-How; (b) Patent Rights; (c) original works, copyrights, moral rights, and mask-works; (d)
trademarks, trade dress, and similar rights based on designation; (e) utility models, designs, and other industrial property rights;
and (f) any other forms of proprietary or industrial rights.
1.25 “Inventions”
means all Intellectual Property Rights that are discovered, made, or conceived by either Party (or both Parties) or any of its Affiliates,
GRDG or Sublicensees, or any of the foregoing Person’s employees, independent contractors, or consultants in the course of conducting
activities under this Agreement.
1.26 “Know-How”
means any information, ideas, data, works of authorship, trade secrets, practices, techniques, procedures, knowledge, skill, experience,
or materials, including formulations, molecules, assays, reagents, compounds, biologic molecules, compositions, methods of treatment,
and/or use thereof, human or animal tissue, samples, or specimens, and combinations or components thereof, whether or not proprietary
or patentable, or public or confidential, and whether stored or transmitted in oral, documentary, electronic, or other form, including
all Regulatory Documentation, but excluding any such information or materials publicly disclosed in Patent Rights.
1.27 “Knowledge”
means a particular fact or other matter that is actually known to a Party.
1.28 “Law”
means any law, statute, rule, regulation, ordinance, or other pronouncement having the effect of law, of any federal, national, multinational,
state, provincial, county, city, or other political subdivision, including (a) good clinical practices and adverse event reporting requirements,
guidance from the International Conference on Harmonization or other generally accepted conventions, and all other rules, regulations
and requirements of the FDA and other applicable Regulatory Authorities, (b) the Foreign Corrupt Practices Act of 1977, as amended, or
any comparable laws in any country, and (c) all export control laws.
1.29 “Licensed
Compound” means any compound covered by one or more claims in the Licensed Patents.
1.30 “Licensed
IP” means the Licensed Patents and the Licensed Know-How.
1.31 “Licensed
Know-How” means all Know-How owned or Controlled by Licensor, Licensor’s Affiliates, and GRDG as of the Effective Date
and learned during the Term that is necessary or useful for the Exploitation of the Licensed Compound and/or any Licensed Product in
the Field in the Territory.
1.32 “Licensed
Patent(s)” means any Patents (including without limitation any Patents that cover Global BioLife’s interest in any Joint
Inventions) owned or Controlled by, or otherwise comes into the Control of, Global BioLife or any of its Affiliates at any time during
the Term that Cover or otherwise claim the Licensed Compound or Licensed Product or necessary for the Exploitation of the Licensed Product.
The Global BioLife Patents that exist as of the Effective Date shall be set forth on an Appendix 1 and Appendix II but the patent application
of Appendix II is limited to patent claims covering monochlorinated myricetin and dichlorinated myricetin.
1.33 “Licensed
Product(s)” means any product comprising or containing a Licensed Compound, alone or in combination with one or more other
active ingredients in any and all forms, in current and future formulations, dosage forms and strengths, and delivery modes. For clarity,
a Licensed Product that contains the same Licensed Compound, but is in a different form, dosage, formulation, strength, presentation
or delivery mode would be considered the same Licensed Product.
1.34 “Licensor”
has the meaning set forth in the introductory paragraph.
1.35 “Licensor
Indemnitees” has the meaning set forth in Section 9.01.
1.36 “NDA”
means (a) (i) a New Drug Application submitted to the FDA, or any successor application or procedure, as more fully defined in 21 C.F.R.
§ 314.50 et seq., or (ii) any non-United States counterpart of such a New Drug Application, and (b) all supplements and amendments,
including supplemental New Drug Applications (and any non-United States counterparts) that may be filed with respect to the foregoing.
1.37 “Net
Revenue” means the gross revenue invoiced in connection with sales of the Licensed Products to any person or entity that is
not an Affiliate or a Sublicensee of ProPhase under the License, after deduction of all the following:
(a) expenses
directed to shipping, such as freight, insurance, import/export fees and other transportation charges to the extent added to the sale
price and set forth separately as such in the total amount invoiced;
(b) taxes
on sales and customs and excise duties and other taxes or duties, to the extent added to the sale price and set forth separately as such
in the total amount invoiced;
(c) typical
credits, discounts, or refunds on returns, including amounts repaid or credited by reason of rejection, defects, return good allowance,
recalls or returns;
(d) seven
percent (7%) of marketing expenses specifically directed to Licensed Products or portion thereof;
(e) the portion of administrative fees paid to group purchasing organizations, pharmaceutical benefit managers or Medicare Prescription
Drug Plans directed to such Licensed Product or portion thereof and
(f) any
royalty payments actually paid to Third Parties that are necessary and required to market Licensed Product in a particular territory
..
Net
Revenue shall be determined on a Licensed Product-by-Licensed Product basis. If ProPhase, its Affiliates or Sublicensees separately sells
in such country, a Combination Product, the Net Revenue attributable to such Combination Product shall include a deduction in the amount
of the lesser of the actual or fair market value of the different active ingredient provided that said amount does not reduce the Net
Revenue received by Global for Licensed Product not sold as a combination.
1.38 “Person”
means any natural person, general or limited partnership, corporation, limited liability company, limited liability partnership, firm,
association, or organization or other legal entity.
1.39 “Phase
1 Study” means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers
or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as further defined in
21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).
1.40 “Phase
2B Study” means a controlled dose ranging Phase 2 Study with a sufficient number of patients to generate sufficient safety
and efficacy data to, if successful, commence a Phase 3 Study.
1.41 “Phase
3 Study” means a controlled study in humans of the efficacy and safety of a product, which is prospectively-designed to demonstrate
statistically whether such product is effective and safe for use in a particular Indication in a manner sufficient to file an NDA to
obtain Regulatory Approval to market the product, as further defined in 21 C.F.R. § 312.21(c) (or the non-United States equivalent
thereof).
1.42 “Pricing
and Reimbursement Approval” means the approval, agreement, determination or decision from a Regulatory Authority establishing
the price and/or reimbursement for Licensed Product for sale in a given country or regulatory jurisdiction of the Territory, as required
by Law in such country or other regulatory jurisdiction prior to or subsequent to the marketing and sale of Licensed Product in such
country or regulatory jurisdiction of the Territory.
1.43 “ProPhase”
has the meaning set forth in the introductory paragraph.
1.44 “Quarter-Year
Report” has the meaning set forth in Section 4.03(e).
1.45 “Regulatory
Approval” means all approvals, licenses, registrations, and authorizations of any federal, national, multinational, state,
provincial, or local Regulatory Authority, department, bureau, and other governmental entity that are necessary and sufficient for the
marketing and sale of a product in a country or group of countries.
1.46 “Regulatory
Authority” means any applicable supra-national, federal, national, regional, state, provincial, or local governmental or regulatory
authority, agency, department, bureau, commission, council, or other entities (e.g., the United States Food & Drug Administration)
regulating or otherwise exercising authority with respect to activities contemplated in this Agreement, including the Exploitation of
the Licensed Products.
1.47 “Regulatory
Documentation” means, with respect to the Licensed Compound and Licensed Products, all INDs, NDAs, and other regulatory applications
submitted to any Regulatory Authority, Regulatory Approvals, pre-clinical and clinical data and information, regulatory materials, drug
dossiers, master files (including Drug Master Files, as defined in 21 C.F.R. § 314.420 and any non-United States equivalents), and
any other reports, records, regulatory correspondence, and other materials relating to Development or Regulatory Approval of the Licensed
Compound or a Licensed Product, or required to manufacture, distribute, or sell the Licensed Products, including any information that
relates to pharmacology, toxicology, chemistry, manufacturing, and controls data, batch records, safety and efficacy, and any safety
database.
1.48 “Right
of Reference” means a “Right of Reference or Use” as that term is defined in 21 C.F.R. § 314.3(b), and any
non-United States equivalents.
1.49
“Sublicense” has the meaning set forth in Section 2.02.
1.50 “Sublicensee”
and “Sublicensees” have the meanings set forth in Section 2.02.
1.51 “Term”
has the meaning set forth in Section 10.
1.52 “Territory”
means worldwide.
1.53 “Third
Party” means any Person other than a Party or any of its Affiliates.
1.54 “United
States” or “U.S.” means the United States of America and its territories and possessions.
1.55 Construction.
In construing this Agreement, unless expressly specified otherwise:
(a) references
to Sections and Exhibits are to sections of, and exhibits to, this Agreement;
(b) except
where the context otherwise requires, use of either gender includes the other gender, and use of the singular includes the plural and
vice versa;
(c) headings
and titles are for convenience only and do not affect the interpretation of this Agreement;
(d) any
list, an example or examples following the word “including” or “includes” shall be interpreted without limitation
to the generality of the preceding words;
(e) except
where the context otherwise requires, the word “or” is used in the inclusive sense (i.e., “A or B” means:
A alone, B alone, or A and B);
(f) all
references to “dollars” or “$” herein shall mean United States Dollars; and
(g) each
Party represents that it has been represented by legal counsel in connection with this Agreement and acknowledges that it has participated
in the drafting hereof. In interpreting and applying the terms and provisions of this Agreement, the Parties agree that no presumption
will apply against the Party which drafted such terms and provisions.
2. GRANT
OF LICENSE.
2.01 Subject
to the reservation of rights set forth in Section 2.02, and other terms and conditions herein set forth, Global BioLife hereby grants
to ProPhase an exclusive right and license, with the right to sublicense (in accordance with Section 2.03) under the Licensed IP to Exploit
the Licensed Compound and Licensed Products in the Field in the Territory, and ProPhase hereby accepts the License.
2.02 Global
BioLife reserves the right, solely for itself and for GRDG to use the Licensed Compound and Licensed IP solely for research purposes
in the Field and for any purpose outside the Field.
2.03 Prophase
may grant sublicenses (including the right to grant further sublicenses) under the License it receives under Section 2.01 to any of its
Affiliates or any Third Party with the prior written consent of Global BioLife, which consent shall not be unreasonably withheld; provided
that: (i) each sublicense is in writing and its terms are consistent with the terms and conditions of this Agreement; (ii) Prophase shall
be responsible to Global BioLife for the performance of its sublicensees; and (iii) any act or omission by a sublicensee that would be
a breach of this Agreement had it been performed (or not performed) by Prophase shall be treated as a breach of this Agreement by Prophase.
Prophase shall remain primarily responsible to Global BioLife for its obligations, including payment obligations pursuant to this Agreement.
3. INFORMATION
TRANSFER
3.01 Initial
Information Transfer to Prophase. All information owned by Global BioLife relating to the Licensed Compound in connection with the
Field has been made available to Prophase prior to the Effective Date or is publicaly available from the USPTO web site (www.uspto.gov).
Further information related to the Licensed Compounds is believed to be available from GRDG and Global BioLife has requested that GRDG
share all such information with Prophase.
4. FINANCIAL
PROVISIONS.
4.01 License
Fee. In partial consideration of the licenses and rights granted to Prophase hereunder, within ten (10) days after the Effective Date,
Prophase shall pay to Global BioLife a one-time upfront license fee of fifty thousand dollars ($50,000).
4.02 Milestone
Payment.
(a) Development
and Regulatory Milestones.
(i) In
partial consideration of the rights granted by Global BioLife to Prophase hereunder and subject to the terms and conditions set forth
in this Agreement, Prophase shall pay to Global BioLife a milestone payment according to Section 4.02(b) after the achievement of each
of the following regulatory milestones:
A. successful
completion of a first Phase 3 Study which may be required by FDA for the first Licensed Product, nine-hundred thousand dollars ($900,000);
and
B. Regulatory
Approval of an NDA for the first Licensed Product, one million dollars ($1,000,000).
(b) Milestone
Payment Procedures. Prophase shall provide Global BioLife with written notice of the achievement of each milestone event within ten
(10) days after achievement of the milestone event set forth in Section 4.02(a). Prophase shall pay to Global BioLife, by wire transfer
to an account designated by Global BioLife, the applicable milestone payment listed above within thirty (30) days after the applicable
notice deadline in this Section 4.02(b).
4.03 Royalties.
(a) Royalty.
Prophase shall pay to Global BioLife 3% royalties on Net Revenue of each Licensed Product in the Territory.
(b) Royalty
Term. Royalties payable under this Section 4.03 shall be paid by Prophase from the date of First Commercial Sale of each Licensed
Product and for the Term of this Agreement. Any payments due under this Section 4.03 shall be subject to any applicable credits
or offsets provided for in this Agreement.
(c) Minimum
Royalty. Notwithstanding Section 4.03 (a) above, with respect to sales of Licensed Products
made in countries, Prophase shall pay to Global BioLife no less than two hundred fifty thousand dollars ($250,000) of Net Revenue per
year minus any possible royalty payments actually paid per year to Third Parties that are necessary and required to market Licensed Product
in a particular territory as per Section 1.34 , commencing the first full calendar year after receiving Regulatory Approval by a Regulatory
Authority to Exploit the first Licensed Product.
(d) Royalty
Reports. For the purpose of computing the royalties due to Licensor hereunder, the year shall be divided into four parts ending on
March 31, June 30, September 30, and December 31. Not later than sixty (60) days after the end of each December, March, June, and September
in each Calendar Year, after the Date of First Commercial Sale and during the Term, ProPhase shall submit to Licensor a report of royalties
due Licensor under the terms of this Section 4 for the preceding quarter year (hereinafter, the “Quarter-Year Report”),
setting forth the Net Revenue upon which such royalties are computed. If no royalties are due, no statement shall be sent to Licensor.
Payment of the full amount of any royalties due for the preceding quarter year shall accompany each Quarter-Year Report on royalties.
Prophase shall keep for a period of at least seven (7) years after the date of entry, accurate and compete books and records relating
to Net Revenue consistent with sound business and accounting practices and in such form and in such detail as to enable the determination
of the amounts due to Licensor pursuant to the terms of this Agreement.
(e) Royalty
Payments. Royalties due to Licensor, if any, shall be paid in United States dollars in conjunction with the submission of each Quarter-Year-Report
and with no deductions for banking, currency conversion charges, wire or other transaction fees.
5. DEVELOPMENT
AND COMMERCIALIZATION.
5.01 General.
Subject to the terms and conditions of this Agreement, Prophase has the sole right to Commercialize Licensed Compound and Licensed Products
in the Field in the Territory; Prophase shall use Commercially Reasonable Efforts to conduct Development activities as set forth in the
Development Plan, as may be amended from time to time by mutual written agreement of the Parties. Prophase shall have the right to subcontract
any Development activities relating to the Licensed Compound and Licensed Products in the Field in the Territory, as deemed appropriate
in Prophase’s reasonable discretion. Prophase has the right, but not the obligation, to directly consult or contract with Daryl
L. Thompson and/or GRDG, at Prophase’s expense, in connection with Development of Licensed Compound and/or Licensed Product. For
the avoidance of doubt, it is understood by the Parties that intellectual property related to Licensed Compound that may be created,
made, developed, or otherwise invented by GRDG and which is funded by Global BioLife shall be owned by Global BioLife, and that all such
new intellectual property shall be Licensed IP under this Agreement.
5.02 Development
Plan. The Development of Licensed Compound and the first Licensed Product for the United States shall be governed by a clinical Development
plan (“Preliminary Development Plan”), a draft of which is provided in Section 5.03.
5.03 Development
Plan. The Parties have prepared a Development Plan, including anticipated timeline goals in connection with the Clinical Trials for
the first Licensed Product. This Development Plan may be amended by mutual written agreement based upon results of preclinical studies
or other Clinical Trial, including safety and effectiveness, guidance by the FDA, or upon agreement of the Parties:
(a) Initiate
preclinical studies with respect to Development of a first Licensed Product within one year of the Effective Date;
(b) Initiate
a Phase 1 Study in connection with Development of a first Licensed Product within 18 months of initiation of the preclinical studies;
provided that an IND for first Licensed Product is approved by FDA;
(c) Initiate
a Phase 2 Study in connection with Development of a first Licensed Product within 24 months of initiation of a first Phase 1 Study; provided
that the Phase 1 Study successfully established safety of the first Licensed Product;
(d) Initiate
a Phase 3 Study in connection with Development of a first Licensed Product within 48 months of initiation of a first Phase 2 Study; provided
that the Phase 2 Study successfully established safety and effectiveness of the first Licensed Product;
(e) Submit
NDA to FDA by January 4, 2027 or as soon as practicable thereafter, using Commercially Reasonable Efforts; provided that Phase 3 Study
is successfully completed; and
(f) Market
first Licensed Product in the United States not later than 30 days after Regulatory Approval by FDA.
5.04 Joint
Meetings. The Parties shall establish semi-annual joint meetings to discuss in good faith and in reasonable detail Prophase’s
and its Sublicencees’ activities and progress related to the Development of Licensed Compound and Licensed Products in the Territory
in accordance with the Development Plan.
6. INTELLECTUAL
PROPERTY.
6.01 Inventions;
Ownership.
(a) Inventor
Assignment Obligation. Each Party shall cause all employees, independent contractors, contract research organizations, consultants,
and others who perform activities for such Party under this Agreement to be under an obligation to assign (or, if such Party is unable
to cause such person or entity to agree to such assignment obligation despite such Party using Commercially Reasonable Efforts to negotiate
such assignment obligation, provide a license under) their rights in any Inventions and Intellectual Property Rights to such Party, except
where applicable Law requires otherwise and except in the case of governmental, not-for-profit, and public institutions which have standard
policies against such an assignment (in which case a suitable license, or right to obtain such a license, shall be obtained).
(b) Ownership
and Disclosure Obligations.
(i) Subject
to the rights and licenses expressly granted under this Agreement, each Party shall retain all rights, title, and interests in, to and
under any and all Intellectual Property Rights that are owned by such Party prior to the Effective Date or independent of this Agreement.
(ii) Inventions
that directly relate to Licensed Compound or Licensed Product in the Field, whether patentable or not, that are made in the course of
performing activities under this Agreement, (a) by either Party, (b) jointly by both Parties, (c) by GRDG, (d) by a Prophase sublicensee,
or (e) jointly by any combination of the preceeding (a) – (d) shall be the joint property of Prophase and Global BioLife (“Joint
Inventions”). The Parties agree to keep each other informed of such Joint Inventions.
(iii) Prophase
and Global BioLife each agree to obtain the cooperation of their respective employees or obligated Third Parties that are inventors in
the preparation, filing, and prosecution of patent applications directed to any Inventions that may arise hereunder.
6.02 Prosecution
and Maintenance of Patent Rights.
(a) At
the initiative of ProPhase or Licensor, the Parties shall consult in good faith with each other regarding the filing, prosecution, and
maintenance of all Licensed Patents. The Licensed Patents shall be diligently filed, prosecuted and maintained by Licensor using reputable
counsel. Licensor shall keep ProPhase reasonably informed with regard to the preparation, filing, prosecution, and maintenance of the
Licensed Patents, including by providing ProPhase (or its designee) copies of office actions issued from patent offices, proposed responses
to such office actions, and any other patent related filings, to be made to such patent authority in the Territory sufficiently in advance
of submitting such filings or responses so as to allow for a reasonable opportunity for ProPhase to review and comment thereon. Licensor
shall consider in good faith any such comments for incorporation into such draft. Licensor represents that during the Term that (a) all
Licensed Patents will be diligently prosecuted in the respective patent offices in the Territory in accordance with applicable laws,
rules and regulations, (b) all Licensed Patents will be filed and maintained properly and correctly, (c) Licensor will pay all applicable
fees on or before the due date for payment, and (d) all Licensed Patents will identify each and every inventor of the claims thereof
as determined in accordance with the laws of the jurisdiction in which such Patent is filed. Prophase shall reimburse Global BioLife
for reasonable attorney fees and patent office costs associated with the prosecution and maintenance of the Licensed Patents on a quarterly
basis commencing on September 30, 2022.
(b) If,
at any time during the Term, the Parties may mutually agree that it is undesirable, as to one or more countries, to file, prosecute or
maintain any Licensed Patent, then Global BioLife shall have discretion to refrain from filing, prosecuting and/or maintaining any Licensed
Patent or permitting the Licensed Patent to lapse.
(c) The
Parties shall cooperate with each other and discuss, in good faith, the Patent Rights within the Licensed Patents Covering the Licensed
Compound and Licensed Products to enable Prophase to make filings with Regulatory Authorities, as required or allowed in connection with
(A) in the United States, the FDA’s Orange Book and (B) outside the United States, under the national implementations of Article
10.1(a)(iii) of Directive 2001/EC/83 or other international equivalents thereof. Global BioLife shall cooperate with Prophase’s
reasonable requests in connection therewith, including meeting any submission deadlines, in each case, to the extent required or permitted
by applicable law.
(d) The
Parties shall cooperate in obtaining Patent Term Extensions pursuant to 35 U.S.C. § 156 and foreign counterparts and equivalents
thereof, including supplementary protection certificates, to the extent such extensions are available with respect to the applicable
Patent Rights (“Extension Activities”).
7. CONFIDENTIAL
INFORMATION.
7.01 Confidential
Information. All Confidential Information of a Disclosing Party shall not be used by the other Party (the “Receiving Party”),
except in performing its obligations or exercising rights explicitly granted under this Agreement and shall be maintained in confidence
by the Receiving Party and shall not otherwise be disclosed by the Receiving Party to any Third Party, without the prior written consent
of the Disclosing Party with respect to such Confidential Information.
7.02 The
obligation of confidentiality and non-use set forth in Section 7.01 shall not apply to any Confidential Information which: (a) was part
of the public domain prior to the Effective Date or which becomes a part of the public domain not due to some unauthorized act by or
omission of receiving Party after the Effective Date, (b) which is disclosed to Receiving Party by a third party who has the right to
make such disclosure, (c) was known by Receiving Party prior to the disclosure of such Confidential Information by Disclosing Party to
Receiving Party, as evidenced by the competent written records of Receiving Party maintained in the ordinary course of business, and
(d) was independently developed by Receiving Party without reliance on such Confidential Information, as evidenced by the competent written
records of Receiving Party maintained in the ordinary course of business.
7.03 The
Parties agree that the financial terms as set forth in this Agreement and the Memorandum of Understanding dated July 1, 2022, shall constitute
Confidential Information of the each Party, and shall be disclosed only to on a need-to-know basis, each Party’s employees, directors,
officers, Affiliates, representatives, and agents subject to any disclosure obligation pursuant to SEC and FDA rules and regulations,
and any rules and regulations of similar authorities around the world. It is further understood by the Parties that the existence of
this Agreement and the Memorandum of Understanding is to be disclosed in a Press Release.
7.04 It
is further agreed that each Party may disclose Confidential Information of the Disclosing Party to the extent that such disclosure is:
(a) in
the reasonable opinion of the Receiving Party’s legal counsel, required to be disclosed pursuant to law, regulation or a valid
order of a court of competent jurisdiction or other supra-national, federal, national, regional, state, provincial and local governmental
body of competent jurisdiction (other than a securities regulatory authority, which is addressed in Section 7.05); provided, that the
Receiving Party shall first have given prompt written notice (and to the extent possible, at least five (5) business days’ notice),
to the Disclosing Party and given the Disclosing Party a reasonable opportunity to take whatever action it deems necessary to protect
its Confidential Information. In the event that no protective order or other remedy is obtained, or the Disclosing Party waives compliance
with the terms of this Agreement, the Receiving Party shall furnish only that portion of Confidential Information which the Receiving
Party is advised by counsel is legally required to be disclosed;
(b) made
by or on behalf of the receiving Party to the Regulatory Authorities as required by applicable laws, rules or regulations; provided,
that reasonable measures shall be taken to assure confidential treatment of such Confidential Information to the extent practicable and
consistent with applicable laws, rules and regulations;
(c) made
by or on behalf of the Receiving Party to a patent authority, as may be reasonably necessary or useful for purposes of obtaining, defending
or enforcing a Patent in accordance with the terms of this Agreement; provided, that reasonable measures shall be taken to assure confidential
treatment of such Confidential Information, to the extent such protection is available;
(d) made
to its or its Affiliates’ financial and legal advisors who have a need to know such Disclosing Party’s Confidential Information
and are either under professional codes of conduct giving rise to expectations of confidentiality and non-use or under written agreements
of confidentiality and non-use, in each case, at least as restrictive as those set forth in this Agreement; provided that the receiving
Party shall remain responsible for any failure by such financial and legal advisors, to treat such Confidential Information as required
under this Section 7;
(e) made
by a Party, its Affiliates or its Sublicensees to potential or actual investors or acquirers as may be necessary in connection with their
evaluation of such potential or actual investment or acquisition; provided, that such persons shall be subject to obligations of confidentiality
and non-use with respect to such Confidential Information substantially similar to the obligations of confidentiality and non-use pursuant
to this Section 7; or
(f) made
by a Party, its Affiliates or Sublicensees to its or their advisors, consultants, clinicians, vendors, service providers, contractors,
existing or prospective collaboration partners, licensees, sublicensees, or other third parties as may be necessary or useful in connection
with the Exploitation of the Licensed Products, or otherwise in connection with the performance of its obligations or exercise of its
rights as contemplated by this Agreement; provided, that such persons shall be subject to obligations of confidentiality and non-use
with respect to such Confidential Information substantially similar to the obligations of confidentiality and non-use of the receiving
Party pursuant to this Section 7.
7.05 The
Parties each acknowledge that the other Party (or its Affiliate) is a publicly traded company. Notwithstanding anything in this Agreement
to the contrary, each Party may (a) make such disclosures with respect to this Agreement as it determines are reasonably necessary to
comply with applicable legal requirements, laws, rules and regulations imposed by a securities regulatory authority; provided that the
disclosing Party shall seek confidential treatment of any disclosure of this Agreement, which such disclosure shall be reviewed by the
non-disclosing Party reasonably in advance of such disclosure to allow the non-disclosing Party to provide comments, which shall be considered
for redaction in good faith by the disclosing Party, and (b) disclose the terms and conditions of this Agreement to any person or entity
conducting due diligence into such Party and its businesses; provided that such person or entity is bound by obligations of confidentiality
and non-use no less restrictive than this Agreement.
7.06 Prophase
has the right, but not the obligation, to work with GRDG in the Development and Exploitation of Licensed Compound and Licensed Product.
Accordingly, it is accepted and agreed by the Parties that Confidential Information may be disclosed to GRDG without violation of this
Agreement. Global Biolife represents that Global Biolife and GRDG have executed a confidentiality agreement substantially similar to
that set forth herein.
8. INFRINGEMENT
OF LICENSED PATENT.
8.01 In
the event a Party becomes aware that a third party is infringing on one or more of the Licensed Patents, the Party that becomes aware
of such infringement shall promptly notify the other Party to the Agreement in writing of such infringement.
8.02 With
respect to any infringing activity that involves the manufacture, use or sale by a Third Party of any product that is believed to and/or
infringe a Licensed Patent (“Infringing Product”), ProPhase shall have the sole right, but not obligation, to bring
suit to enforce any Licensed Patent against the infringer and/or to defend any declaratory judgment action with respect thereto (either
of which shall be considered as an “Action”) and, upon initiating any Action, shall keep Licensor reasonably informed
with regard to the status of such suit and related activities.
8.03 Each
Party shall always have the right to be represented by counsel of its own selection at its own cost in any suit for infringement of the
Licensed Patent(s).
8.04 Licensor
agrees to cooperate in the litigation with ProPhase at the reasonable request and at the sole expense of ProPhase, including, by giving
testimony and producing documents lawfully requested in the prosecution of any suit by ProPhase for infringement of the Licensed Patent(s).
8.05 Any
recovery from such infringement suit shall be distributed to the Parties as follows: (a) first, reimbursement of the costs and expenses
incurred by or on behalf of ProPhase and then Global BioLife’s expenses, if any, in connection with such Action; and (b) second,
any remaining recovery shall, to the extent the same pertains to an infringing activity that involves the manufacture, use or sale by
a third party of any Infringing Product, be treated as Net Revenue.
8.06 In
the event Prophase elects not to initiate an Action with respect to any commercially significant infringing activity that involves the
manufacture, use or sale by a Third Party of any Infringing Product, Global BioLife may initiate such Action at its sole expense. Prophase
shall have the right to participate in any such Action with counsel of its own choice at its own expense. All recoveries received by
Global BioLife from an Action shall be first applied to reimburse Global BioLife’s and then Prophase’s unreimbursed expenses,
including, without limitation, reasonable attorney’s fees and court costs. Global BioLife is entitled to any remainder of the recovery.
8.07 Neither
Party shall settle an Action with an infringer without the consent of the other Party, such consent shall not be unreasonably withheld.
9. LIABILITY
AND INDEMNIFICATION.
9.01 ProPhase
shall indemnify, defend and hold harmless Licensor and its directors, officers, and employees and their respective successors, heirs
and assigns (the “Licensor Indemnitees”), against any liability, damage, loss or expense (including reasonable attorneys’
fees and expenses) incurred by or imposed upon the Licensor Indemnitees or any one of them in connection with any third party claims,
suits, actions, demands or judgments arising out of (a) the Exploitation of a Licensed Compound or Licensed Product by or on behalf of
ProPhase, (b) a wilful breach by Licensee of this Agreement, or (c) the gross negligence or wilful misconduct of a ProPhase Indemnitee
in connection with this Agreement.
9.02 The
Indemnitees shall provide Prophase (“Indemnitor”) with prompt written notice of any claim, suit or action for which indemnification
is sought; provided that the failure of an Indemnitee so to notify Indemnitor will not relieve Indemnitor from liability for indemnification
only if and to the extent such failure materially compromises Indemnitor’s defense of such claim, suit or action. Indemnitor agrees,
at its own expense, to provide attorneys reasonably acceptable to Licensor on behalf of the Licensor Indemnitees to defend against any
such claim, suit or action. The Indemnitees shall cooperate fully with Indemnitor in such defense, at Indemnitor’s expense, and
will permit Indemnitor to conduct and control such defense and the disposition of any such claim, suit, or action; provided that (a)
Indemnitor shall not settle any such claim, suit or action that (i) admits any liability or wrongdoing on behalf of an Indemnitee, or
(ii) obligates an Indemnitee to take, or restricts an Indemnitee from taking, any action, in either case ((i) or (ii)), without the prior
written consent of Licensor on behalf of the Licensor Indemnitees, which consent shall not be unreasonably denied, and (b) any Indemnitee
shall have the right to retain its own counsel, at the expense of Indemnitor, if representation of such Indemnitee by the counsel retained
by Indemnitor would be inappropriate because of actual differences in the interests of such Indemnitee and any other Party represented
by such counsel. Indemnitor agrees to keep Licensor reasonably informed of the progress in the defense and disposition of such claim,
suit or action and to consult with Licensor with regard to any proposed settlement.
9.03 NEITHER
PARTY NOR ANY OF ITS AFFILIATES OR SUBLICENSEES SHALL BE LIABLE FOR INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, PUNITIVE OR CONSEQUENTIAL
DAMAGES, INCLUDING LOSS OF PROFITS OR BUSINESS INTERRUPTION, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, TORT,
NEGLIGENCE, BREACH OF STATUTORY DUTY OR OTHERWISE IN CONNECTION WITH OR ARISING IN ANY WAY OUT OF THE TERMS OF THIS AGREEMENT OR THE
TRANSACTIONS CONTEMPLATED HEREBY OR THE USE OF THE COMPOUND OR PRODUCT, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.
10. TERM
AND TERMINATION
10.01 Term.
Unless earlier terminated pursuant to this Section 10, this Agreement shall commence on the Effective Date and expire automatically
on a country-by-country basis upon the last to occur of the expiration of the last-to-expire Licensed Patents (“Term”). Following
the expiration of the Term, and on a country-by-country basis, the License shall become non-exclusive, perpetual, fully-paid, unrestricted,
royalty-free and irrevocable.
10.02 Termination.
(a) Termination
by Prophase for Convenience. Prophase shall have the right to terminate this Agreement for any reason or for convenience in its sole
discretion: (i) on a Licensed Product-by-Licensed Product or a country-by-country basis or (ii) in its entirety, in either case ((i)
or (ii)) for convenience upon one hundred eighty (180) days prior written notice to Global BioLife. Prophase shall perform any obligations
owed to Global BioLife as of the date of said termination notice.
(b) Termination
by Global BioLife. Global BioLife shall have the right to terminate this Agreement only for uncured material breach by Prophase as
follows: if Global BioLife believes that the Prophase is in material breach of its obligations under this Agreement, then Global BioLife
may provide written notice to the Prophase setting forth a description of the asserted material breach. Prophase shall then have the
option to cure such asserted material breach within sixty (60) days after actual receipt of such written notice (or such longer period
as may be agreed by the Parties). If Prophase does not cure such breach by the end of the sixty (60) days period to the satisfaction
of Global BioLife after the other Party provides notice of such breach as above, then Global BioLife may then terminate the Agreement
immediately on written notice to Prophase.
(c) Challenging
Validity. During the term of this Agreement, Prophase and its Affiliates (“Challenging Party”) shall not challenge the
validity or ownership of Licensed Patents (“Patent Challenge”) or knowingly assist a Third Party in a Patent Challenge. Global
BioLife at its sole and absolute option may terminate this Agreement upon written notice to Prophase, upon the commencement by Challenging
Party of a Patent Challenge.
10.03 Effects
of Termination. If this Agreement is terminated in its entirety by either Party, or on Licensed Product-by-Licensed Product or a
country-by-country basis, then with respect only to such Licensed Product or such country, as the case may be (it being understood that,
if this Agreement is terminated in its entirety, then all references below to “terminated Licensed Product” shall instead
be references to all Licensed Products, and “the terminated countries” shall instead be references to “the Territory”):
(a) Any
Termination. In the event of any termination of this Agreement and regardless of the terminating Party:
(i) all
rights and licenses granted by Global BioLife hereunder shall immediately terminate and be of no force or effect with respect to the
terminated Licensed Product in the terminated countries;
(ii) promptly
after the notice date of any such termination or otherwise after effective date of such termination, Prophase, at its sole cost, shall
commence winding down its Exploitation activities for the terminated Licensed Products in the terminated countries, and shall use good
faith efforts to complete any and all such wind-down Development and Commercialization activities within three (3) months after the notice
date or effective date of such termination, as applicable;
(iii) Prophase
may sell off its existing inventory of terminated Licensed Products for a period of six (6) months subject to, if applicable, the milestones
and royalty provisions of this Agreement; and
(iv) if
such termination is a termination of this Agreement in its entirety, each Party shall promptly return all Confidential Information of
the other Party that are not subject to a continuing license hereunder.
(b) Termination
by Prophase. In the event of a termination by Prophase:
(i) upon
written request by Global BioLife within thirty (30) days following such termination, unless prohibited by Regulatory Authority, Prophase
shall transition the conduct of any on-going Clinical Trials to Global BioLife;
(ii) if
this Agreement is terminated in its entirety or as to a terminated Licensed Product on a country-by country or worldwide basis, Prophase
shall, at no cost to Global BioLife: (A) assign to Global BioLife or Global BioLife’s designee all Regulatory Documentation that
is requested by Global BioLife and/or necessary for Global BioLife to Exploit such terminated Licensed Product in the terminated country
and (B) provide to Global BioLife or Global BioLife’s designee a Right of Reference and right to use in the terminated country
all Regulatory Documentation that is necessary to Exploit, but not solely related to, such terminated Licensed Product in the terminated
country; and
(iii) if
termination is with respect to one or more Licensed Products other than on a worldwide basis, Prophase shall provide to Global BioLife
or Global BioLife’s designee, at no expenses, a Right of Reference and right to use in the terminated country all Regulatory Documentation
necessary to Exploit the terminated Licensed Product in the terminated country.
11. REPRESENTATIONS
AND WARRANTIES BY PROPHASE.
ProPhase
hereby represents and warrants to Licensor as follows:
11.01 ProPhase
is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware. ProPhase has been granted
all requisite power and authority to carry on its business and to own and operate its properties and assets. The execution, delivery
and performance of this Agreement have been duly authorized by ProPhase.
11.02 There
is no pending or, to ProPhase’s Knowledge, threatened litigation involving ProPhase which would have any effect on this Agreement
or on ProPhase’s ability to perform its obligations hereunder; and
11.03 There
is no indenture, contract, or agreement to which ProPhase is a party or by which ProPhase is bound which prohibits or would prohibit
the execution and delivery by ProPhase of this Agreement or the performance or observance by ProPhase of any term or condition of this
Agreement.
12. REPRESENTATIONS
AND WARRANTIES BY LICENSOR.
Licensor
hereby represents and warrants to ProPhase as follows:
12.01 Licensor
is a corporation duly organized, validly existing and in good standing under the laws of Nevada. Licensor has been granted all requisite
power and authority to carry on its business and to own and operate its properties and assets. The execution, delivery and performance
of this Agreement have been duly authorized by Licensor.
12.02 There
is no pending or, to Licensor’s knowledge, threatened litigation involving Licensor which would have any effect on this Agreement
or on Licensor’s ability to perform its obligations hereunder.
12.03 To
Licensor’s knowledge, there is no indenture, contract, or agreement to which Licensor is a party or by which Licensor is bound
which prohibits or would prohibit the execution and delivery by Licensor of this Agreement or the performance or observance by Licensor
of any term or condition of this Agreement.
12.04 All
Licensed IP existing as of the Effective Date is solely and exclusively owned by Licensor.
12.05 To
Licensor’s Knowledge, all Licensed Patents existing as of the Effective Date are subsisting and are not invalid or unenforceable,
in whole or in part.
12.06 To
Licensor’s Knowledge, the Licensed Patents existing as of the Effective Date (a) are being diligently prosecuted in the respective
patent offices in the Territory in accordance with applicable laws, rules and regulations, (b) have been filed and maintained properly
and correctly and all applicable fees have been paid on or before the due date for payment, and (c) identifies each and every inventor
of the claims thereof as determined in accordance with the laws of the jurisdiction in which such Patent is issued or such application
is pending.
12.07 To
Licensor’s Knowledge, there are no claims, judgments, or settlements against, or amounts with respect thereto, owed by Licensor
or any of its Affiliates relating to the Licensed IP.
12.08 No
claim or litigation has been brought or, to Licensor’s Knowledge, threatened by any person or entity alleging, that (a) the Licensed
Patents existing as of the Effective Date are invalid or unenforceable, or (b) the Licensed IP, or the disclosing, copying, making, assigning,
or licensing of the Licensed IP, or the Exploitation of the Licensed Compounds or Licensed Products as contemplated herein, does or will
violate, infringe, misappropriate or otherwise conflict or interfere with, any Patent or other intellectual property or proprietary right
of any person or entity.
12.09 To
Licensor’s Knowledge, the Exploitation of the Licensed Compound or Licensed IP does not violate, infringe, misappropriate, or otherwise
conflict or interfere with any Patent or other intellectual property or proprietary right of any person or entity.
12.10 To
Licensor’s Knowledge, no person or entity is infringing or threatening to infringe or misappropriating or threatening to misappropriate
the Licensed IP.
12.11 To
Licensor’s Knowledge, with respect to the pending patent applications included in the Licensed Patents existing as of the Effective
Date, Licensor and its Affiliates have presented all relevant references, documents, or information of which it and the inventors are
aware to the relevant patent examiner at the relevant patent office.
12.12 To
Licensor’s Knowledge, no funding from any governmental entity of any kind was used in connection with development of any of the
intellectual property rights included in the scope of the License.
12.13 To
Licensor’s Knowledge the Licensed Compound has not been used in humans in any form on behalf of Licensor or its Affiliates prior
to the Effective Date.
13. COMPLIANCE.
Each
Party and its Affiliates (a) have complied and shall comply with all applicable laws, rules and regulations governing bribery, money
laundering, and other corrupt practices and behavior (including, as applicable, the U.S. Foreign Corrupt Practices Act and UK Bribery
Act) and (b) shall not, directly or indirectly, offer, give, pay, promise to pay, or authorize the payment of any bribes, kickbacks,
influence payments, or other unlawful or improper inducements to any person or entity in whatever form (including gifts, travel, entertainment,
contributions, or anything else of value).
14. NO
ASSIGNMENT.
Neither
party shall assign this Agreement or any part thereof without the prior written consent of the other party, which consent shall not be
unreasonably withheld or delayed. Each party may, however, without such consent, assign or sell its rights under this Agreement (a) in
connection with the sale or transfer of all or substantially all of its assets to a Third Party; (b) in the event of a merger or consolidation
with a Third Party; or (c) to an Affiliate. No assignment shall relieve any party of responsibility for the performance of any accrued
obligation which such party has under this Agreement. Any assignment shall be contingent upon the assignee assuming in writing all of
the obligations of its assignor under this Agreement.
15. USE
OF NAME; PUBLIC ANNOUNCEMENTS.
Without
the prior written consent of the other Party, neither ProPhase nor Licensor shall use the name of the other Party or any adaptation thereof
or of any employee of the other Party, unless such use is otherwise required by law, rule or regulation. Except as provided herein, Licensor
will not issue any public announcements about this Agreement without prior written approval of ProPhase. Notwithstanding the preceding,
it is agreed by the Parties that one or more Press Release may be published relating to this Agreement and that each Party shall provide
the other with an opportunity to review and revise such Press Releases.
16. MISCELLANEOUS.
16.01 Neither
Party shall be held liable or responsible to the other Party or be deemed to have defaulted under or breached this Agreement for failure
or delay in fulfilling or performing any term of this Agreement when such failure or delay is caused by or results from events beyond
the reasonable control of the non-performing Party, including fires, floods, earthquakes, hurricanes, embargoes, shortages, epidemics,
quarantines, war, acts of war (whether war be declared or not), terrorist acts, insurrections, riots, civil commotion, strikes, lockouts,
or other labor disturbances (whether involving the workforce of the non-performing Party or of any other person), acts of God or acts,
omissions or delays in acting by any governmental authority (except to the extent such delay results from the breach by the non-performing
Party or any of its Affiliates of any term or condition of this Agreement). The non-performing Party shall notify the other Party of
such force majeure event within thirty (30) days after such occurrence by giving written notice to the other Party stating the nature
of the event, its anticipated duration, and any action being taken to avoid or minimize its effect. The suspension of performance shall
be of no greater scope and no longer duration than is necessary and the non-performing Party shall use commercially reasonable efforts
to remedy its inability to perform.
16.02 If
any provision of this Agreement is determined to be invalid or void, the remaining provisions shall remain in effect.
16.03 Both
Parties irrevocably consent to first present any dispute related to this Agreement in writing to the other Party. Within two (2) months
of receipt of such notice, the Parties agree to attend a face-to-face meeting which shall include at least one individual from each Party
who is authorized to make decisions for and settle the dispute. Such a meeting shall be held at a location agreed upon by the Parties.
In the event that good faith negotiations are unsuccessful, the Parties shall present the dispute to non-binding mediation before a single
mediator in a location agreed upon by the Parties. The Party first initiating the dispute shall present a list of no less than five potential
mediators to the other Party and that Party shall promptly select one mediator therefrom. Should nonbinding mediation be unsuccessful,
as determined by the chosen mediator or either Party, the dispute may be presented to litigation in the federal or state courts of the
State of Texas.
16.04 This
Agreement is governed by the internal laws of the State of Texas, without regard and to the exclusion of Texas’ conflict of laws
rules. The United Nations Convention for the International Sale of Goods is excluded and shall not apply. The Parties hereby submit to
the sole and exclusive jurisdiction of, and waive any venue objections against, the state and federal courts located in the State of
Texas.
16.05 All
payments or notices required or permitted to be given under this Agreement shall be given in writing and shall be effective when either
personally delivered or deposited, postage prepaid, in the United States registered or certified mail, or sent via a recognized national
overnight delivery service (e.g., Federal Express or DHL), addressed as follows:
| |
To Licensor: |
Global Biolife, Inc. |
| |
|
1400 Broadfield Blvd., Suite 100 |
| |
|
Houston, TX 77084 |
| |
|
Attention: Frank D. Heuszel |
| |
|
Email: frank.heuszel@dssworld.com and |
| |
|
fheuszel@impactbiomedinc.com |
| |
|
With copy to, which shall not constitute notice: |
| |
|
| |
|
Remenick PLLC |
| |
|
1025 Thomas Jefferson Street, NW; Suite 175 |
| |
|
Washington, DC 20007 |
| |
|
Attention: James Remenick |
| |
|
E-mail: jremenick@remenicklaw.com |
| |
To ProPhase: |
ProPhase Labs, Inc. |
| |
|
711 Stewart Ave, Suite 200 |
| |
|
Garden City, NY 11530 |
| |
|
Attention: Ted Karkus |
| |
|
E-mail: karkus@prophaselabs.com |
| |
|
| |
|
With copy to, which shall not constitute notice: |
| |
|
| |
|
Reed Smith LLP |
| |
|
599 Lexington Avenue, 22nd Floor |
| |
|
New York, NY 10022 |
| |
|
Attention: Herbert Kozlov |
| |
|
E-mail: hkozlov@reedsmith.com |
or
such other address or addresses as either Party may hereafter specify by written notice to the other. Such notices and communications
shall be deemed effective on the date of delivery or fourteen (14) days after having been sent by registered or certified mail, whichever
is earlier.
16.06 This
Agreement (and the annexed appendices) constitute the entire Agreement between the Parties relating to the subject matter hereof, and
no variation, modification or waiver of any of the terms or conditions hereof shall be deemed valid unless made in writing and signed
by both Parties. This Agreement supersedes any and all prior agreements or understandings, whether oral or written, between the Parties
relating to the subject matter hereof.
16.07 No
waiver by either Party of any non-performance or violation by the other Party of any of the covenants, obligations or agreements of such
other Party hereunder shall be deemed to be a waiver of any subsequent violation or non-performance of the same or any other covenant,
agreement or obligation, nor shall forbearance by either Party be deemed to be a waiver by such Party of its rights or remedies with
respect to such violation or non-performance.
16.08 The
descriptive headings contained in this Agreement are included for convenience and reference only and shall not be held to expand, modify
or aid in the interpretation, construction or meaning of this Agreement.
16.09 It
is not the intent of the Parties to create a partnership or joint venture or to assume partnership responsibility or liability. The obligations
of the Parties shall be limited to those set out herein and such obligations shall be several and not joint.
16.10 This
Agreement may be executed in one or more counterparts, each of which will be deemed an original, and all of which will constitute one
and the same instrument. Each Party may execute this Agreement by facsimile transmission or in Portable Document Format sent by electronic
means. Signatures of authorized signatories of the Parties transmitted by facsimile or sent by electronic means in Portable Document
Format shall be deemed to be original signatures, shall be valid and binding, and, upon delivery, shall constitute due execution of this
Agreement.
IN
WITNESS WHEREOF, the Parties hereto have executed this Agreement effective as of the date and year first above written.
| ProPhase Labs, Inc. |
|
| |
|
| By: |
/s/ Ted Karkus |
|
| Name: |
Ted Karkus |
|
| Title: |
CEO |
|
| |
|
| Date: |
7/19/2022 |
|
| |
|
| Global BioLife, Inc. |
|
| |
|
| By: |
/s/ Frank D. Heuszel |
|
| Name: |
Frank D. Heuszel |
|
| Title: |
CEO |
|
| |
|
|
| Date: |
July 18, 2022 | |
APPENDIX
I
Licensed
Patents existing as of the Effective Date
| |
|
Patent
appln. no. |
|
Patent
no. |
|
Title |
|
Filing
Date |
|
Issue
Date |
|
Country |
| 1 |
|
2017268240 |
|
[pending] |
|
Electrophilically
Enhanced Phenolic Compounds for Treating Inflammatory Related Diseases and Disorders |
|
16-Nov-2018 |
|
|
|
AU |
| 2 |
|
BRI12018073634.1 |
|
[pending] |
|
Electrophilically
Enhanced Phenolic Compounds for Treating Inflammatory Related Diseases and Disorders |
|
16-Nov-2018 |
|
|
|
BR |
| 3 |
|
3,024,728 |
|
[pending] |
|
Electrophilically
Enhanced Phenolic Compounds for Treating Inflammatory Related Diseases and Disorders |
|
16-Nov-2018 |
|
|
|
CA |
| 4 |
|
201780043667.1 |
|
[pending] |
|
Electrophilically
Enhanced Phenolic Compounds for Treating Inflammatory Related Diseases and Disorders |
|
14-Jan-2019 |
|
|
|
CN |
| 5 |
|
17800008.9 |
|
[pending] |
|
Electrophilically
Enhanced Phenolic Compounds for Treating Inflammatory Related Diseases and Disorders |
|
10-Dec-2018 |
|
|
|
EP |
| 6 |
|
19129214.3 |
|
[pending] |
|
Electrophilically
Enhanced Phenolic Compounds for Treating Inflammatory Related Diseases and Disorders |
|
05-Sep-2019 |
|
|
|
HK |
| 7 |
|
201817043242 |
|
[pending] |
|
Electrophilically
Enhanced Phenolic Compounds for Treating Inflammatory Related Diseases and Disorders |
|
16-Nov-2018 |
|
|
|
IN |
| 8 |
|
2018-560998 |
|
[pending] |
|
Electrophilically
Enhanced Phenolic Compounds for Treating Inflammatory Related Diseases and Disorders |
|
15-Nov-2018 |
|
|
|
JP |
| 9 |
|
2022-012056 |
|
[pending[ |
|
Electrophilically
Enhanced Phenolic Compounds for Treating Inflammatory Related Diseases and Disorders |
|
28-Jan-2022 |
|
|
|
JP |
| 10 |
|
10-2018-7036052 |
|
[pending] |
|
Electrophilically
Enhanced Phenolic Compounds for Treating Inflammatory Related Diseases and Disorders |
|
12-Dec-2018 |
|
|
|
KR |
| 11 |
|
2018141590 |
|
[pending] |
|
Electrophilically
Enhanced Phenolic Compounds for Treating Inflammatory Related Diseases and Disorders |
|
27-Nov-2018 |
|
|
|
RU |
| 12 |
|
15/156,021 |
|
10,123,991 |
|
Electrophilically
Enhanced Phenolic Compounds for Treating Inflammatory Related Diseases and Disorders |
|
16-
May- 2016 |
|
13-Nov-18 |
|
US |
| 13 |
|
16/302,292 |
|
10,966,954 |
|
Electrophilically
Enhanced Phenolic Compounds for Treating Inflammatory Related Diseases and Disorders |
|
16-Nov
- 2018 |
|
6-Apr-21 |
|
US |
| 14 |
|
PCT/US21/22538 |
|
|
|
Electrophilically
Enhanced Phenolic Compounds for Treating Inflammatory Related Diseases and Disorders |
|
16-May-2017 |
|
|
|
WO |
**
END **
APPENDIX
II
Licensed
Patent Application existing as of the Effective Date
| Patent
appln. no. |
|
Patent
no. |
|
Title |
|
Filing
Date |
|
Country |
| 17/530,956 |
|
[pending] |
|
Method
And Composition for Rendering Cancer Cells Susceptible to Treatment by Targeted Oncogenetic Drivers |
|
19-Nov-2021 |
|
US |
