UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K/A
(Amendment
No. 1)
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
Date
of Report (Date of earliest event reported): August 19, 2014
CARDAX,
INC.
(Exact
name of registrant as specified in its charter)
Delaware |
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333-181719 |
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45-4484428 |
(State
or other jurisdiction of
incorporation) |
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(Commission
File Number) |
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(IRS
Employer
Identification No.) |
2800
Woodlawn Drive, Suite 129, Honolulu, Hawaii 96822
(Address
of principal executive offices) (Zip Code)
Registrant’s
telephone number, including area code: (808) 457-1400
(Former
name or former address, if changed since last report)
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 (see General Instruction A.2. below):
[ ] |
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)) |
ITEM
8.01 OTHER EVENTS
This
Current Report on Form 8-K/A is filed as an amendment to the Current Report on Form 8-K filed by Cardax, Inc. (the “Company”)
on August 19, 2014 (the “Original 8-K”). The Company is amending Item 9.01 of the Original 8-K to replace the
Collaboration Agreement dated August 18, 2014, made by and between Capsugel US, LLC and its affiliates and Cardax, Inc. and its
affiliates, that was filed as Exhibit 10.1 to the Original 8-K. The Company has modified certain redactions of the agreement provided
in Exhibit 10.1, in response to information it disclosed in its Registration Statement on Form S-1, Registration No. 33-195745,
for which the Company no longer request confidential treatment.
ITEM
9.01 FINANCIAL STATEMENTS AND EXHIBITS
Exhibit
No. |
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Description |
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10.1 |
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Collaboration
Agreement, dated as of August 18, 2014, by and between Capsugel US, LLC and its affiliates and Cardax, Inc. and its affiliates* |
* Confidential
treatment has been requested for this exhibit, and confidential portions have been filed separately with the Securities and Exchange
Commission
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.
Dated: December
3, 2014
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CARDAX, INC. |
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By: |
/s/ David G.
Watumull |
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David G. Watumull |
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Chief Executive
Officer |
Exhibit
10.1
COLLABORATION
AGREEMENT
THIS
COLLABORATION AGREEMENT (“Agreement”) is made as of this 18th day of August 2014 (the “Effective
Date”), by and between Capsugel US, LLC and its Affiliates with an address at 412 Mt. Kemble Ave, Suite 200C, Morristown,
NJ 07960 (“CAPSUGEL”) and Cardax, Inc., and its Affiliates, with a corporate address at 2800 Woodlawn Dr.,
Suite 129, Honolulu, HI 96822 (“CARDAX”). CARDAX and CAPSUGEL are each a “Party” and together constitute
the “Parties”
RECITALS
WHEREAS,
CAPSUGEL is experienced in formulating, developing, manufacturing, testing and packaging of health and nutrition products;
and
WHEREAS,
CARDAX is experienced in developing products that are based on its astaxanthin technologies; and
WHEREAS,
CAPSUGEL and CARDAX desire to enter into an arrangement under which the Product (as defined below) will be formulated and developed
for the purpose of identifying a marketing partner(s) (“Marketer”) for Marketer’s onward sale of the
Product in the Territory.
NOW,
THEREFORE, the Parties hereto agree to the following:
SECTION
1
DEFINITIONS
The
following terms for the purpose of this Agreement shall have the following respective meanings:
1.1
“Active Ingredient” shall mean the synthetic Astaxanthin and/or esters thereof that will be formulated in the
Product as the active ingredient of the Product.
1.2
“Adjusted Net Sales” shall mean [***].
1.3
“Administrative Cost” shall mean [***].
1.4
“Affiliate” shall mean, with respect to either Party, all entities which, directly or indirectly, are controlled
by, control or are under common control with such Party. For purposes of this Agreement, the word “control” shall
mean the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of an
entity, including through ownership of more than fifty percent (50%) of the voting shares or interest of an entity; provided,
however, with respect to CAPSUGEL, the term “Affiliate” shall be limited to entities who directly or indirectly through
one or more intermediaries are controlled by the parent of CAPSUGEL’s direct parent entity and with respect to CARDAX the
term “Affiliate” shall not include Cardax Pharmaceuticals, Inc.
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT UNDER RULE 24B-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 1 |
1.5
“Applicable Laws” shall mean all applicable laws, statutes, ordinances, codes, rules and regulations applicable
to the formulation, development and/or manufacture, marketing, distribution sale, and disposal of the Product or any aspect thereof
and the obligations of CAPSUGEL or CARDAX, as the context requires under this Agreement.
1.6
“Annual Period” shall mean the twelve (12) month period beginning on the first day in which the Launch Date
occurs and each twelve (12) month period beginning on the anniversary of such day thereafter.
1.7
“Commercially Reasonable Efforts” means a Party’s reasonable efforts and diligence, consistent with professional
business standards generally practiced in the health and nutrition industry, applied in accordance with the Party’s commercially
reasonable business, legal, medical and scientific judgment, including the efforts and resources the Party would use for a product
owned by it or to which it has rights, which is of similar market potential at a similar stage in its product life, taking into
account the competitiveness of the marketplace, the proprietary position of the compound, the Applicable Laws, the profitability
of the applicable products, and other relevant factors including, without limitation, technical, legal, scientific or medical
factors.
1.8
“Development Plan” shall have the meaning set forth in Section 2.1.
1.9
“Disclosing Party” shall have the meaning set forth in the Confidentiality Agreement.
1.10
“Formulation” means a specific combination of excipient(s) that can formulate the Active Ingredient, as well
as compounds other than the Active Ingredient, developed as a result of the work conducted under the Development Plan.
1.11
“Force Majeure” shall have the meaning set forth in Section 10.5.
1.12
“Indemnified Party” shall have the meaning set forth in Section 8.3.
1.13
“Indemnifying Party” shall have the meaning set forth in Section 8.3.
1.14
“Intellectual Property Rights” means a composition of matter, formula, process, method of use, invention, improvement,
business name, domain name or database right to the extent any of the foregoing is protected in a utility model, trademark, service
mark, trade name or business name, copyright, registered design, design right, patent, know-how, trade secret, rights in or to
confidential information all goodwill related thereto and any other intellectual property right of any nature whatsoever throughout
the world (whether registered or unregistered and including all applications and rights to apply for the same).
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT UNDER RULE 24B-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 2 |
1.15
“Launch Date” shall mean the date upon which Marketer first offers the Product for commercial sale in the Territory.
1.16
“Loss or Losses” shall mean any and all damages, fines, fees, settlements, payments, obligations, penalties,
deficiencies, losses, costs and expenses, including, without limitation, environmental losses, interest, court costs, reasonable
fees of attorneys, accountants and other experts and other reasonable expenses of litigation or other proceedings or of any claim,
default or assessment.
1.17
“Manufacturing Facility” shall mean those areas of CAPSUGEL or CAPSUGEL’s subcontractors manufacturing,
packaging, laboratory and warehousing facilities utilized in the formulation, manufacture, packaging, storage, testing, shipping
or receiving of the Product.
1.18
“Materials” mean all excipient(s) and inactive raw materials used in the formulation of the Product. For the
avoidance of doubt, “Materials” does not include any Active Ingredient or work in process or finished goods inventory.
1.19
“Net Sales” means [***].
1.20
“Product” shall mean Active Ingredient Formulated in CAPSUGEL’s proprietary Lipid Multi-Particulate Technology,
including any improvements or derivatives of such technology.
1.21
“Receiving Party” shall have the meaning set forth in the Confidentiality Agreement.
1.22
“Regulatory Approvals” means any and all approvals, licenses, registrations, or authorizations of the relevant
Regulatory Authority, necessary for the development, manufacture, use, storage, import, transport, export or commercialization
of the Product in a particular country or jurisdiction.
1.23
“Regulatory Authority (ies)” means any governmental regulatory authority within a Territory involved in regulating
any aspect of the development, manufacture, testing, market approval, sale, distribution, packaging or use of the Product.
1.24
“Regulatory Filings” shall mean the registrations, permits, licenses, authorizations, presentations, notifications,
filings and/or approvals (together with all applications therefore and all related documents required by the FDA and all other
laws for the development, manufacture, use, importation, export, marketing, sale and distribution of the Product within the Territory.
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT UNDER RULE 24B-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 3 |
1.25
“Royalty Payment” shall have the meaning set forth in Section 5.1.
1.26
“Specifications” shall mean the Product description and attributes agreed upon between the Parties upon conclusion
of the Development Plan and appended to this Agreement as Exhibit B that will be attached hereto and, when attached, will
be a part hereof, prior to commercialization of the Product.
1.27
“Territory” shall mean worldwide.
Section
2
Product
Development, Manufacture and Commercialization
2.1 |
Governance
Process Among the Parties. Both CARDAX and CAPSUGEL will agree upon a development plan, which shall be in writing
and attached hereto as Exhibit A (the “Development Plan”), which shall describe various parameters
including each Party’s duties, obligations, time schedule and deliverables schedule. The activities performed under
the Development Plan (the “Development Activities”) shall be administered by a joint project team (“JPT”),
which shall review/update/amend the Development Plan for the Product in the Territory and coordinate the Formulation, development,
manufacturing and commercialization of the Product, including identifying and selecting one or more Marketers as contemplated
under Section 2.4. Each Party shall appoint a project manager to oversee that Party’s performance of its obligations under
this Agreement and shall notify the other Party of the name and full contact details of its appointed project manager. The
JPT shall comply with this Agreement for decisions specifically assigned to a Party pursuant to this Agreement. Meetings shall
take place by telephone or in person and the JPT will operate by consensus. If consensus cannot be reached, the matter will
be submitted to the Head of Dosage Form Solutions of CAPSUGEL and the President and CEO of CARDAX for resolution. If such
matter is not resolved, then the Parties may attempt to mediate such issue under the JAMS mediation rules. No member or any
Affiliate of any member of the JPT shall have any liability under this Agreement and shall be exculpated to the fullest extent
not prohibited by law from any liability to any Party that such member is not an employee, officer, consultant or acting in
any similar capacity. |
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2.2 |
CAPSUGEL
Responsibilities. With respect to the Product, CAPSUGEL, [***] shall [***] perform the development work necessary
to formulate, analytically develop and take all other developmental actions necessary or required to develop the Product and
manufacture pre-clinical and clinical batches (collectively, the “CAPSUGEL Development Activities”). For
purposes of further clarification, CAPSUGEL Development Activities shall include, without limitation, each of the following
performed with all due diligence, care and skill and in accordance with all other Applicable Laws: |
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CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT UNDER RULE 24B-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 4 |
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(a) |
Formulation
Development. Formulation shall mean a specific combination of Materials that formulate the Active Ingredient, as well
as compounds other than the Active Ingredient, developed as a result of the work conducted under the Development Plan. The
development of the Formulation of the Product, includes without limitation, all stability tests and other studies as applicable,
providing CARDAX reports of such stability tests, using Commercially Reasonable Efforts to modify the Formulation as necessary
and develop processes capable of scale-up and commercialization in accordance with Applicable Laws. |
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(b) |
Analytical
Methods. Developing and validating analytical methods including but not limited to dissolution, assay, and stability as
agreed upon by the Parties. |
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(c) |
Manufacture
of Study Batches. The manufacture [***] of batches of Product in amounts specified on or about the dates determined as
reasonably necessary for conducting all required for CAPSUGEL/CARDAX funded studies. Any other batches required or reasonably
required by the Marketer for applying for and all actions related to additional Regulatory Approvals and Regulatory Filings
of the Product and any related communications, studies or support for the FDA or any other Regulatory Authority (ies), which
may include human and animal studies, shall be paid for by the Marketer, unless the Parties agree otherwise. |
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(d) |
Manufacturing
Development. Development of manufacturing processes and systems in conformance with cGMP requirements of FDA to manufacture
pilot batches, exhibit batches and commercial batches of Product. |
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(e) |
Reporting.
CAPSUGEL shall, throughout the performance of the Development Plan studies, consult with CARDAX on matters including technical,
intellectual property and regulatory aspects and keep the other apprised of all developments. |
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(f) |
Commercial
Manufacturing. CAPSUGEL shall manufacture the Product for each Marketer unless otherwise agreed by the Parties and the
applicable Marketer. |
2.3 |
CARDAX
Responsibilities. |
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(a) |
CARDAX
shall be responsible for [***] the Active Ingredient [***], subject to reasonable notice and delivery schedules and reasonable
amounts required by CAPSUGEL for it to perform its obligations under this Agreement or as otherwise agreed by CARDAX. |
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(b) |
[***] |
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT UNDER RULE 24B-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 5 |
2.4 |
Joint
Responsibilities. |
[***]
The
marketing of the Product shall be carried out by one or more mutually identified Marketer(s) by the JPT or otherwise in accordance
with Section 2.1. CAPSUGEL and CARDAX will jointly control identification, decision rights, and terms for a Marketer as determined
by the JPT or otherwise in accordance with Section 2.1. If a Marketer is not identified, or the terms are not determined, by the
JPT or otherwise in accordance with Section 2.1, then the Marketer (and such terms) may be designated by either Party, subject
to the reasonable approval of the other Party.
Any
additional costs/activities required from a Marketer will be subject to agreement of the JPT or otherwise as provided in Section
2.1, including but not limited to pre-launch out-of-pocket expenses and the funding of such costs and expenses. These costs will
be shared [***].
2.5 |
Ownership
of Application. CARDAX shall own and control all information and rights in, to and under all Regulatory Approvals
in the Territory (including all associated contents and correspondences) and applications therefore related to the Product
and any other marketing authorizations within the Territory, unless otherwise mutually agreed upon by the Parties. |
Section
3
Intellectual
Property Matters
3.1
Background IP. This Agreement shall not change, modify or otherwise affect any rights
to any confidential information, inventions, patents, patent applications or other Intellectual Property Rights owned or developed
by either Party before the Effective Date or developed by a Party after the Effective Date other than under the terms of this
Agreement (“Background IP”). This Agreement shall not confer on either Party
any rights in and/or to any Background IP of the other party, except as otherwise provided in this Agreement.
3.2
CAPSUGEL Property. CARDAX acknowledges that CAPSUGEL possesses certain inventions,
processes, know-how, trade secrets, improvements, other intellectual properties and other assets, including but not limited to
formulation recipes, processing details, laboratory analyses, analytical methods, procedures and techniques, computer technical
expertise and software, which have been independently developed by CAPSUGEL, including but not limited to, the Background IP of
CAPSUGEL (collectively “Capsugel Property”). CARDAX and CAPSUGEL agree that
any Capsugel Property or improvements thereto which are used, improved, modified or developed by CAPSUGEL under or during the
term of this Agreement are the product of CAPSGUEL’s technical expertise possessed and developed by CAPSUGEL prior to the
Effective Date and are the sole and exclusive property of CAPSUGEL.
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT UNDER RULE 24B-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 6 |
3.3
CARDAX Property. CAPSUGEL acknowledges that CARDAX possesses certain inventions,
processes, know-how, trade secrets, improvements, other intellectual properties and other assets, which have been independently
developed by CARDAX, including but not limited to, the Background IP of CARDAX (collectively “CARDAX Property”).
CAPSUGEL and CARDAX agree that any CARDAX Property or improvements thereto which are used, improved, modified or developed by
CARDAX under or during the term of this Agreement are the product of CARDAX’s technical expertise possessed and developed
by CARDAX prior to the Effective Date and are the sole and exclusive property of CARDAX.
3.4
Use of Confidential Information. CARDAX may use the confidential information of CAPSUGEL generated under this Agreement,
except for CAPSUGEL’s internal technical protocols and Background IP, to the extent necessary (i) in connection with seeking
regulatory approval for a Compound Formulation or the Product and/or (ii) filing a patent application. “Compound Formulation”
means any specific combination of excipient(s) and the Active Ingredient developed as a result of the work conducted under
this Agreement. CARDAX may use and disclose CAPSUGEL’s internal technical protocols and Background IP, to the extent necessary
for Regulatory Approvals as contemplated by Section 2.3(b) to the extent reasonably determined by CAPSUGEL after notice and consultation
with CAPSUGEL by CARDAX.
3.5
Inventions. Each Party will own all of its inventions and other Intellectual Property Rights made under this Agreement,
including any patents, patent applications and other Intellectual Property Rights related to such inventions, if any, made solely
by its employees or independent contractors or employees or independent contractors of its Affiliates, unless otherwise expressly
set forth herein.
3.6
Joint Inventions. The Parties will jointly own all inventions and other Intellectual Property Rights jointly made under
this Agreement that are directly resulting from work conducted under this Agreement in accordance with the Development Plan and
related specifically to the Product or the Compound Formulation, including any patents, patent applications and other Intellectual
Property Rights related to such inventions, if any, unless otherwise expressly set forth herein. During the Term, each Party hereby
provides a worldwide, exclusive, royalty free, perpetual license of such Intellectual Property Rights for use by each licensee
in its business in connection with the development and marketing and commercialization of the Product. For avoidance of doubt,
no Party or any of its Affiliates shall have any rights to the Background IP of the other Party nor shall any Party have rights
to any trademarks, service marks, trade names, business names or product names developed by the other Party. All decisions regarding
the protection and exploitation of joint investments and other Intellectual Property Rights shall be determined by the JPT or
otherwise in accordance with Section 2.1.
3.7
[reserved]
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT UNDER RULE 24B-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 7 |
3.8
Freedom to Operate. CARDAX acknowledges that it shall be solely and fully responsible
to use its Commercially Reasonable Efforts for doing any and all freedom to operate assessments regarding possible infringement
of third party intellectual property rights for the Product in the part of the Territory that the Parties reasonably determine
require such protection; provided, however, each Party shall be solely and fully responsible for doing any and all freedom to
operate assessments regarding possible infringement of third party intellectual property rights for any and all of its Intellectual
Property Rights.
Section
4
Exclusivity
[***]
Section
5
Consideration
5.1
Royalty Payments. CAPSUGEL shall pay to CARDAX a royalty equal to [***]
of the Adjusted Net Sales (“Royalty Payment”) within [***] after
the end of [***].
5.2
Mode of Payment. CAPSUGEL will endeavor to contract with Marketer to receive profit sharing payments in U.S. dollars
and CAPSUGEL will in turn pay CARDAX its share in U.S. dollars. Should Marketer require that local currency based payments be
made to CAPSUGEL then CAPSUGEL will pay CARDAX its share in such local currency unless otherwise agreed. For instances in which
Marketer sells the product in a local currency other than U.S. dollars but agrees to pay CAPSUGEL in U.S. dollars, the conversion
of local currency to USD will be a mutually agreeable methodology with such Marketer (e.g., using the Marketer’s standard
accounting methodology such as its average daily rate for its accounting month).
5.3
Taxes. All federal, national, regional, district, local or other governmental income tax or similar tax that is imposed
on either Party as a result of income, shall be the responsibility of such Party. All amounts payable by CAPSUGEL to CARDAX under
this Agreement shall be paid free and clear of all deductions or withholdings whatsoever, except as may be required by law. If
any deductions or withholdings are required by law to be made from any of the amounts payable by CAPSUGEL to CARDAX, the amount
of any such withholding may be treated as part of the Royalty Payment, depending on the timing and the applicable legal requirements
and CAPSUGEL shall provide CARDAX a receipt of any such withholdings.
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT UNDER RULE 24B-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 8 |
Section
6
Regulatory
Requirements
6.1
Regulatory Contacts. [***] CAPSUGEL shall notify CARDAX immediately, and in no event, no later than three (3) business
day(s), after it receives any contact or communication from any governmental or regulatory authority, including without limitation
the FDA, that in any way relates to or may have an impact on a Product or the CAPSUGEL Development Activities.
6.2
Regulatory Inspections. Throughout the Term of this Agreement, CAPSUGEL agrees to cooperate with any governmental or
regulatory body, particularly the FDA, which requests a general GMP inspection or audit or any inspection or audit relative to
the manufacture, storage, handling, or shipment of Product manufactured, stored, handled, or shipped by CAPSUGEL. In addition,
CAPSUGEL shall use its Commercially Reasonable Efforts to meet all reasonable U.S. FDA and other appropriate regulatory demands.
6.3
CARDAX Inspection. CARDAX shall have the right to audit CAPSUGEL’s facilities, quality systems and records from
time to time upon reasonable notice and CARDAX shall have the right to have a third party accounting firm, subject to a non-disclosure
agreement, audit CAPSUGEL’s financials as they relate to Net Sales and Adjusted Net Sales. In the event that the amount
of the Royalty Payment for any quarter is 10% or more than the amount reported by CAPSUGEL, then CAPSUGEL will pay the costs and
expenses of the audit or investigation.
6.4
Regulatory Notices. CAPSUGEL shall provide prompt written notice to CARDAX of the occurrence of, and the results of
any regulatory notices including inspections as referenced in this Section 6 relating to the manufacture of Product.
6.5
Recordkeeping. CAPSUGEL shall keep true, accurate, and complete books, records, reports, and accounts (hereinafter
“Records”) of all business or activities in connection with or relating to the manufacture, storage, handling,
and shipment, including all validations, qualification, and validation protocols, of Product and this Agreement. CARDAX has the
right, upon reasonable prior notice and during normal business hours, to inspect and examine such Records. CAPSUGEL agrees to
retain all such Records for a period of five (5) years after the expiration of the Term or after termination of this Agreement.
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT UNDER RULE 24B-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 9 |
6.6
Recall. In the event that either Party believes it may be necessary to conduct a recall, field correction, market withdrawal,
stock recovery, or other similar action with respect to any Product which was sold under this Agreement (a “Recall”),
CARDAX and CAPSUGEL shall promptly consult with each other in good faith as to how best to proceed, it being understood and agreed
that the final decision as to any Recall of any Product sold by Marketer(s) shall be made jointly; provided, however, that neither
Party shall be prohibited hereunder from taking any action that it is required to take by Applicable Law or taking Commercially
Reasonable Efforts to mitigate the loss from any Recall or seizure or to protect the public. Each of CAPSUGEL and CARDAX shall
make a permanent, complete and accurate record of all costs incurred by it in connection with any Product Recall or seizure. With
respect to any Recall or seizure of any Product caused by the negligence, mistake or omission of CAPSUGEL, CAPSUGEL shall (i)
reimburse CARDAX for all out-of-pocket costs and expenses reasonably incurred by CARDAX in connection with the Recall or seizure,
including, without limitation, replacing the Product subject to the Recall or seizure in accordance with this Agreement; and (ii)
as provided in Section 8.1, indemnify and save CARDAX and its Affiliates harmless from and against any and all damages to or claims
by third parties associated (or Affiliated) with or resulting from any such Recall or seizure. With respect to any Recall or seizure
caused by the negligence, mistake or omission of CARDAX (including but not limited to failure of the Active Ingredient to meet
the Specifications), CARDAX shall: (i) reimburse CAPSUGEL for all out-of-pocket costs and expenses reasonably incurred by CAPSUGEL
in connection with the Recall or seizure; and (ii) as provided in Section 8.2, indemnify and save CAPSUGEL and its Affiliates
harmless from and against any and all damages to or claims by third parties associated with or resulting from any such Recall
or seizure.
With
respect to any Recall or seizure of a Product not caused by the negligence, mistake or omission of either Party, each Party shall
bear [***] of the aggregate costs of any and all out-of-pocket costs, expenses and losses reasonably incurred by either Party
in connection with the Recall or seizure.
If
CAPSUGEL and CARDAX cannot agree which party is at fault or whether a Recall or seizure was reasonably beyond the control of the
Parties, then an independent technical expert, acceptable to both Parties, shall be designated to make such determination. The
designated technical expert shall not be an employee, consultant, officer, director or shareholder of, or otherwise associated
with, CAPSUGEL, CARDAX or their respective Affiliates. The technical expert’s determination will be, in the absence of fraud
or manifest error, binding and conclusive upon the Parties.
Each
Party shall keep the other fully informed of any notification or other information, whether received directly or indirectly, which
might affect the marketability, safety or effectiveness of a Product, or which might result in liability issues or otherwise necessitate
action on the part of either party, or which might result in Recall or seizure of the Product.
Prior
to any reimbursement pursuant to this Section 6 the Party claiming reimbursement shall provide the other Party with all available
documentation of all reimbursable costs and expenses.
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT UNDER RULE 24B-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 10 |
Section
7
Representations
and Warranties
7.1
Representations and Warranties of CAPSUGEL. CAPSUGEL hereby represents and warrants to CARDAX as follows:
|
(a) |
CAPSUGEL
is a corporation in good standing under the laws of the jurisdiction of its organization and authorized to do business wherever
necessary to fulfill the terms and conditions of this Agreement; |
|
|
|
|
(b) |
CAPSUGEL
has the full power and authority to execute and deliver this Agreement and perform its covenants, duties and obligations described
in this Agreement; |
|
|
|
|
(c) |
This
Agreement is the valid, legal and binding obligation of CAPSUGEL, enforceable in accordance with its terms; |
|
|
|
|
(d) |
Neither
the execution and delivery of this Agreement nor the performance of CAPSUGEL’s covenants, duties and obligations described
in this Agreement constitute or will constitute a default under or conflict with any judgment, decree or order of any court
or other governmental body to which CAPSUGEL is subject and will not conflict or be inconsistent with or result in the termination,
modification, breach or default under the terms of any contract, commitment, covenant, agreement, instrument, document or
understanding to which CAPSUGEL is a party; |
|
|
|
|
(e) |
CAPSUGEL
is not a party to, nor to CAPSUGEL’s knowledge is CAPSUGEL as of the Effective Date threatened with, any legal or equitable
action or proceeding before any court, arbitrator, administrative agency or other tribunal which is reasonably likely to adversely
affect its ability to execute and deliver this Agreement or fully and timely perform its covenants, duties and obligations
described in this Agreement; |
|
|
|
|
(f) |
CAPSUGEL
has obtained and continuously maintained all permits, authorizations and licenses issued by all federal, state and local governmental
agencies and authorities necessary for the conduct of CAPSUGEL’s businesses as of the Effective Date; |
|
|
|
|
(g) |
CAPSUGEL
has and shall continue to follow, comply with and adhere to all Applicable Laws necessary for the conduct of CAPSUGEL’s
businesses; |
CAPSUGEL
shall during the performance of the CAPSUGEL Development Activities ensure that, at all times, its employees, contractors, consultants,
sub-contractors carry out their duties with all reasonable skill and care customary for the type of scientific research and development
work covered by this Agreement and shall at all times comply with all applicable laws and regulations; record experimental data
and all other material information relating to the CAPSUGEL Development Activities in individual notebooks or other appropriate
formats and treat the same as Confidential Information; ensure that, at all times, its employees, contractors, consultants and
sub-contractors are fully aware of and comply with the confidentiality provisions of their respective contracts which, for the
avoidance of doubt, are comparable to the confidentiality provisions set out in this Agreement; keep CARDAX informed of the progress
of the CAPSUGEL Development Activities by providing bi-weekly written reports and such other interim reports or updates as CARDAX
may reasonably request.
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT UNDER RULE 24B-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 11 |
7.2
Representations and Warranties of CARDAX. CARDAX hereby represents and warrants to CAPSUGEL as follows:
|
(a) |
CARDAX
is a corporation in good standing under the laws of the jurisdiction of its organization and authorized to do business wherever
necessary to fulfill the terms and conditions of this Agreement; |
|
|
|
|
(b) |
CARDAX
has the full power and authority to execute and deliver this Agreement and perform its covenants, duties and obligations described
in this Agreement; |
|
|
|
|
(c) |
This
Agreement is the valid, legal and binding obligation of CARDAX, enforceable in accordance with its terms; |
|
|
|
|
(d) |
Neither
the execution and delivery of this Agreement nor the performance of CARDAX’s covenants, duties and obligations described
in this Agreement constitute or will constitute a default under or conflict with any judgment, decree or order of any court
or other governmental body to which CARDAX is subject and will not conflict or be inconsistent with or result in the termination,
modification, breach or default under the terms of any contract, commitment, covenant, agreement, instrument, document or
understanding to which CARDAX is a party; |
|
|
|
|
(e) |
CARDAX
is not a party to, nor to CARDAX’s knowledge is CARDAX as of the Effective Date threatened with, any legal or equitable
action or proceeding before any court, arbitrator, administrative agency or other tribunal which is reasonably likely to adversely
affect its ability to execute and deliver this Agreement or fully and timely perform its covenants, duties and obligations
described in this Agreement; and |
|
|
|
|
(f) |
CARDAX
has obtained and continuously maintains all permits, authorizations and licenses issued by all federal, state and local governmental
agencies and authorities necessary for the conduct of CARDAX’s businesses as of the Effective Date. |
Disclaimer.
THE REPRESENTATIONS AND WARRANTIES SET FORTH IN THIS AGREEMENT ARE THE PARTIES’ ONLY WARRANTIES AND NO OTHER WARRANTY, EXPRESS,
IMPLIED OR STATUTORY, WILL APPLY. EACH PARTY EXPRESSLY DISCLAIMS ALL OTHER WARRANTIES, WHETHER EXPRESS, IMPLIED OR STATUTORY,
INCLUDING WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. FOR THE AVOIDANCE OF DOUBT, EACH PARTY EXPRESSLY
DISCLAIMS ANY AND ALL WARRANTIES OF NON-INFRINGEMENT THAT ARE NOT EXPRESSLY SET FORTH IN THIS AGREEMENT.
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT UNDER RULE 24B-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 12 |
Section
8
Indemnification
8.1
CAPSUGEL’s Indemnification of CARDAX. CAPSUGEL shall indemnify, defend and hold CARDAX, its Affiliates and their
respective officers, directors, employees and agents harmless from and against any and all third party Losses suffered, incurred
or sustained by CARDAX or to which CARDAX becomes subject at any time, to the extent arising out of or resulting, directly or
indirectly, from: (a) any breach of CAPSUGEL’s representations, warranties or obligations under this Agreement; (b) any
personal injury, death or property damage caused by the possession, use, or consumption by any person of any Product that does
not comply with the Specification in any way or is the result of actions or inactions of CAPSUGEL in its manufacturing or is alleged
to result from any inherent risk of the Formulation or a defect in the Formulation; and (c) any other negligent act or omission
on the part of CAPSUGEL, its Affiliates or their respective employees or agents except, in each case, to the extent such claims
are attributable to the gross negligence or willful misconduct of CARDAX.
8.2
CARDAX’s Indemnification of CAPSUGEL. CARDAX shall indemnify, defend and hold CAPSUGEL, its Affiliates and their respective
officers, directors, employees and agents harmless from and against any and all third party Losses suffered, incurred or sustained
by CAPSUGEL or to which CAPSUGEL becomes subject at any time, to the extent arising out of or resulting, directly or indirectly,
from (a) any breach of CARDAX’s representations, warranties or obligations under this Agreement; (b) any personal injury,
death or property damage caused by the possession, use or consumption by any person of any Product supplied by CAPSUGEL under
this Agreement that does not comply with the Specifications as a result of actions or inactions of CARDAX or is alleged to result
from any inherent risk of the Product or a defect in the Active Ingredient; and (c) any other negligent act or omission on the
part of CARDAX, its Affiliates or their respective employees or agents except, in each case, to the extent such claims are attributable
to the gross negligence or willful misconduct of CAPSUGEL.
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT UNDER RULE 24B-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 13 |
8.3
Indemnification Process. If CARDAX, Affiliates or their respective employees, servants or agents, or CAPSUGEL, its
Affiliates or their respective employees, servants or agents (in each case an “Indemnified Party”), receive
any written claim which such Indemnified Party believes is the subject of indemnity hereunder by the other Party hereto (an “Indemnifying
Party”), the Indemnified Party shall, as soon as reasonably practicable after forming such belief, give notice thereof
to the Indemnifying Party, provided that the failure to give timely notice to the Indemnifying Party as contemplated hereby
shall not release the Indemnifying Party from any liability to the Indemnified Party unless the Indemnifying Party demonstrates
that the defense of such claim is prejudiced by such failure. The Indemnifying Party shall have the right, by prompt notice to
the Indemnified Party to assume the defense of such claim at its cost, with counsel reasonably satisfactory to the Indemnified
Party. If the Indemnifying Party does not so assume the defense of such claim or, having done so, does not diligently pursue such
defense, the Indemnified Party may assume the defense, with counsel of its choice, but at the cost of the Indemnifying Party.
If the Indemnifying Party so assumes the defense, it shall have absolute control of the litigation; the Indemnified Party may,
nevertheless, participate therein through counsel of its choice and at its cost. The Party not assuming the defense of any such
claim shall render all reasonable assistance to the Party assuming such defense, and out-of-pocket costs of such assistance shall
be for the account of the Indemnifying Party. No such claim shall be settled other than by the Party defending the same, and then
only with the consent of the other Party, which consent shall not be unreasonably withheld; provided that the Indemnified
Party shall have no obligation to consent to any settlement of any such claim which (i) imposes on the Indemnified Party
any liability or obligation which cannot be assumed or performed in full by the Indemnifying Party, (ii) does not unconditionally
release the Indemnified Party, (iii) does require a statement as to or an admission of fault, culpability or failure to act
by or on behalf of Indemnified Party or any of its Affiliates or (iv) does impose any restrictions on the conduct of business
by the Indemnified Party or its Affiliates.
8.4
Limitation of Damages. IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR ANY CONSEQUENTIAL, SPECIAL OR PUNITIVE DAMAGES
OR LOST PROFITS ARISING UNDER OR RELATING TO THIS AGREEMENT. Except in the event of (i) a Party’s gross negligence or willful
misconduct and/or (ii) a Party’s breach of its confidentiality obligation, the total liability of one Party to the other
Party (and its Affiliates) arising out of or in connection with this Agreement or the Products, whether in contract, tort (including
negligence), statute or otherwise, shall, to the maximum extent permitted by Applicable Law, be limited to the amount of revenues
it receives under this Agreement.
8.5
Insurance. During the Term and for a period of two (2) years after the termination of the Agreement or the expiry date
of the last batch manufactured whichever is later, thereafter, each Party shall obtain and maintain, at its sole expense adequate
product liability insurance for the Product as it reasonably deems necessary and appropriate. Evidence of coverage, in the form
of certificates of insurance, shall be provided promptly upon registration of the Product in given countries and as reasonably
requested thereafter.
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT UNDER RULE 24B-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 14 |
Section
9
Confidentiality
and Publicity
Confidentiality.
The Parties agree that the terms of the Confidentiality Agreement entered into between the parties dated Nov 19, 2013 shall govern
this Agreement.
Section
10
Term
and Termination
10.1 Term
and Renewal. The initial term of this Agreement shall be for three (3) years from the Launch Date; provided, however,
that this Agreement shall automatically renew every three (3) years subject to the achievement of certain Commercial
Milestones (unless waived by both parties) to be set forth in Exhibit C, [***] In addition, any contract entered into
by the Parties with a Marketer for the Product shall survive termination of this Agreement in accordance with its terms,
including any renewal rights provided therein.
10.2
Termination for Breach. A material breach that is subject to cure that is not cured within [***] of written notice
of breach shall be cause for termination, provided that if the breaching party is diligently pursuing in good faith the remedy
of the breach at the expiration of such [***] cure period, then such [***] cure period shall be extended for a reasonable period
to effect the cure. Upon any breach by CAPSUGEL, CARDAX shall be permitted to use all Intellectual Property of CAPSUGEL used in
the Formulation and the Product to the extent necessary for the development and marketing of the Product. Upon any breach by CARDAX,
CAPSUGEL shall be permitted to use all Intellectual Property of CARDAX used in the Active Ingredient and the Product to the extent
necessary for the development and marketing of the Product in accordance with the terms of this Agreement as of the date of such
termination.
10.3
Termination for Bankruptcy. This Agreement may be terminated by either Party, forthwith, or at any time thereafter
by notice to the other if the other becomes bankrupt or insolvent, or enters into liquidation whether compulsorily or voluntarily,
or convenes a meeting of its creditors, or has a receiver appointed over all or part of its assets, or ceases for any reason to
carry on business.
10.4
Development or Commercial Non-Viability.
In
the event that CAPSUGEL reasonably determines that the development of the Compound Formulation is not feasible with Commercially
Reasonable Efforts in accordance with the Development Plan, with such changes as reasonably requested by CAPSUGEL, then CAPSUGEL
may discontinue the development of the Compound Formulation and Product and terminate this Agreement, in which case, CARDAX shall
have the right to license the Intellectual Property Rights as provided in Section 4.
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT UNDER RULE 24B-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 15 |
In
the event that CARDAX reasonably determines that, with Commercially Reasonable Efforts by the Parties, the development of a Product
is not feasible due to any legal, or technical developments with respect to the Product, including but not limited to conflicts
of Intellectual Property Rights; withdrawal of a Product by a major regulatory agency for safety or efficacy reasons; or inability
of the Parties to produce a Product that passes FDA required biostudies, in which such developments make the Product nonviable
or that the Product is not acceptable to any applicable Marketer, then, CARDAX may elect to discontinue the development of the
Product and terminate this Agreement.
10.5
Termination for Force Majeure. Neither Party shall be liable to the other for default or delay in the performance of
any of its obligations under this Agreement if such default or delay shall be caused directly or indirectly by accident, fire,
flood, riot, war, terrorism, act of God, embargo, strike, failure or delay of normal source of supply of materials, or delay of
carriers, equipment failure or complete or partial shutdown of plant by any of the foregoing causes or other causes beyond its
reasonable control, including FDA action (“Force Majeure”).
10.6
No Waiver. The failure of either Party to terminate this Agreement by reason of the breach of any of its provisions
by the other Party shall not be construed as a waiver of the rights or remedies available for any subsequent breach of the terms
and provisions of this Agreement.
10.7
Property. In the event of termination of this Agreement for whatever cause, in addition to the other obligations of
the Parties hereunder, each Party shall return to the other Party or to the other Party’s designee no later than thirty
(30) days after the effective date of termination all of such other Party’s property, including all proprietary information,
in its possession, except to the extent required to be retained by law or to comply with such Party’s continuing obligations
hereunder.
10.8
Survival. The provisions of Sections 3.6, 4, 6, 8, 9 and 11 shall survive any termination of this Agreement.
Section
11
Miscellaneous
11.1
Dispute Resolution. This Agreement shall be governed by and interpreted in accordance under the laws of the State of
New York. Any dispute, controversy or claim arising out of this Agreement, or the breach, termination or invalidity thereof, shall
be discussed between the senior management of the Parties who will attempt to resolve the matter amicably. Any disputes which
cannot be resolved in this way within sixty (60) days of one Party notifying the other of the existence of a dispute shall be
finally settled before JAMS in accordance with the expedited arbitration procedures of JAMS. The arbitration shall be conducted
in English in New York, New York, USA. The costs of the arbitration payable to JAMS shall be funded equally by the parties, provided
that the prevailing party shall be reimbursed for such costs and expenses and its own actual out of pocket costs
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT UNDER RULE 24B-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 16 |
11.2
Integration and Amendment. This Agreement, the Exhibits hereto contain the complete agreement between the Parties with
respect to the subject matter hereof. All previous and collateral agreements, representations, warranties, promises and conditions
relating to the subject matter of this Agreement are superseded by this Agreement. This Agreement may only be amended by a written
instrument duly executed by the Parties hereto.
11.3
Assignment. Neither Party may assign this Agreement without the prior written consent of the other Party; provided,
however that either Party may assign in connection with a merger or sale of all or substantially all of its stock or assets, provided
the assignee agrees to be bound by all of the terms and conditions of this Agreement.
11.4
Waiver. No waiver of any default by either Party shall be deemed to constitute a waiver of any subsequent default with
respect to the same or any other provision hereof. No waiver shall be effective unless made in writing with specific reference
to this Agreement and signed by a duly authorized representative of the Party granting the waiver.
11.5
Notice. Any notice or request expressly provided for or permitted under this Agreement shall be in writing, delivered
manually or by mail, e-mail, or facsimile and shall be deemed sufficiently given if and when received by the Party to be notified
at its address first set forth below, or if and when mailed by registered mail or certified mail, postage prepaid, addressed to
such Party at such address, or upon delivery confirmation. Either Party, by notice to the other, may change its address for receiving
such notices.
If
to CAPSUGEL: |
CAPSUGEL
US, LLC |
|
412
Mt. Kemble Ave. Suite 200C |
|
Morristown,
NJ 07960 USA |
|
Attn:
President, Dosage Form Solutions |
Telephone: |
[***] |
Facsimile: |
[***] |
E-mail: |
[***] |
|
|
With
a copy to |
CAPSUGEL
US, LLC |
|
412
Mt. Kemble Ave. Suite 200C |
|
Morristown,
NJ 07960 USA |
|
Attn:
General Counsel |
Telephone: |
[***] |
Facsimile: |
[***] |
E-mail: |
[***] |
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT UNDER RULE 24B-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 17 |
If
to CARDAX: |
CARDAX,
Inc. |
|
2800
Woodlawn Dr., Suite 129 |
|
Honolulu,
HI 96822 |
|
Attn:
President and CEO |
Telephone: |
[***] |
Facsimile: |
[***] |
E-mail: |
[***] |
|
|
With
a copy to |
Herrick,
Feinstein LLP |
|
2
Park Avenue |
|
New
York, NY 10016 |
|
Attn:
Richard M. Morris |
Telephone: |
[***] |
Facsimile:
|
[***] |
E-mail: |
[***] |
11.6
Severability of Provisions. Each provision of this Agreement shall be treated as a separate and independent clause,
and the unenforceability of any one clause shall in no way impair the enforceability of any of the other clauses herein. Moreover,
if one or more of the provisions contained in this Agreement shall for any reason be held to be excessively broad as to scope,
activity, subject or otherwise so as to be unenforceable at law, such provision or provisions shall be construed by the appropriate
judicial body or arbitration panel by limiting or reducing such provision or provisions, so as to be enforceable to the maximum
extent allowable under the applicable law as such law shall then be.
11.7
Independent Contractors. Each Party hereto shall be an independent contractor of the other. Neither Party shall be
the legal agent of the other for any purpose whatsoever and therefore has no right or authority to make or underwrite any promise,
warranty or representation, to execute any contract or otherwise to assume any obligation or responsibility in the name of or
on behalf of the other Party, except to the extent specifically authorized in writing by the other Party. Neither Party shall
be bound by or liable to any third persons for acts or obligations or debts incurred by the other toward such third party, except
to the extent specifically agreed to in writing by the Party to be so bound. This Agreement shall not create a partnership or
other similar arrangement.
11.8
Announcement. The Parties agree to coordinate external communications (e.g. joint press release) regarding this collaboration.
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT UNDER RULE 24B-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 18 |
11.9
Headings; Interpretation. The section headings contained in this Agreement are for convenience of reference only, do
not form a part of this Agreement and shall not affect in any way the meaning or interpretation of this Agreement. Whenever the
context may require, any pronoun shall include the corresponding masculine, feminine and neuter forms. The words “include,”
“includes” and “including” shall be deemed to be followed by the phrase “but not limited to.”
All references herein to Sections, Sections and Exhibits shall be deemed references to Sections and Sections of, and Exhibits
to, this Agreement unless the context shall otherwise require. All Exhibits attached to this Agreement shall be deemed incorporated
herein by reference as if fully set forth herein. Words such as “herein,” “hereof,” “hereto,”
“hereby” and “hereunder” refer to this Agreement and to the Exhibits, taken as a whole. Except as otherwise
expressly provided herein: (a) any reference in this Agreement to any agreement shall mean such agreement as amended, restated,
supplemented or otherwise modified from time to time; (b) any reference in this Agreement to any law shall include corresponding
provisions of any successor law and any regulations and rules promulgated pursuant to such law or such successor law; and (c) all
terms of an accounting or financial nature shall be construed in accordance with generally accepted accounting principles, as
in effect in the United States from time to time.
11.10
Counterparts. This Agreement may be executed by the Parties hereto in separate counterparts, each of which when so
executed and delivered shall be deemed an original and all of which counterparts taken together shall constitute but one and the
same instrument.
*
* * Signature Page Follows * * *
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT UNDER RULE 24B-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 19 |
IN
WITNESS WHEREOF, the Parties have caused this this Agreement to be executed by their respective duly authorized representatives
as of the day and year first above written.
CAPSUGEL
US, LLC
By:
|
/s/
Amit Patel |
|
Name:
|
Amit
Patel |
|
Title: |
President,
Dosage Form Solutions |
|
CARDAX,
INC.
By: |
/s/
David G. Watumull |
|
Name: |
David
G. Watumull |
|
Title: |
President
and CEO |
|
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT UNDER RULE 24B-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 20 |
EXHIBIT
A
DEVELOPMENT
PLAN
[***six
pages omitted***]
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT UNDER RULE 24B-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 21 |
EXHIBIT
B
SPECIFICATIONS
As provided
in Section 1.26, to be provided upon conclusion of the Development Plan
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT UNDER RULE 24B-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 22 |
EXHIBIT
C
[***]
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT UNDER RULE 24B-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 23 |
EXHIBIT
D
MASS
MARKET CHANNELS
[***]
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT UNDER RULE 24B-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 24 |
Cardax (CE) (USOTC:CDXI)
Gráfica de Acción Histórica
De May 2024 a Jun 2024
Cardax (CE) (USOTC:CDXI)
Gráfica de Acción Histórica
De Jun 2023 a Jun 2024