Nicotinamide Riboside Supply Agreement between Thorne Research, Inc. & Chromadex, Inc. Nicotinamide Riboside-Choline and/or Betaine
***Text
Omitted and Filed Separately
with
the Securities and Exchange Commission.
Confidential
Treatment Requested
Under
17 C.F.R. Sections 200.80(b)(4) and Rule 24b-2 of the
Securities
Act of 1934, as amended.
Exhibit 10.1
Addendum
to
Xxxxxx
Research, Inc. & Chromadex, Inc.
Nicotinamide Riboside-Choline and/or Betaine
and/or Dimethylglycine Combination Product
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Seller
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Chromadex,
Inc.
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Buyer
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Xxxxxx
Research, Inc.
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Product
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Nicotinamide
Riboside Chloride (Product Specification attached
hereto)
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Term
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As
defined by the NIAGEN® SUPPLY AGREEMENT, dated July 9, 2013
(“Original Agreement”)
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Intent
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1) To add Choline and/or
Betaine and/or dimethylglycine (DMG) to the Original
Agreement (hereinafter the NR-Choline-Betaine-DMG Combination
Product)
2) To permit Buyer the
sole rights to the Combination of Nicotinamide Riboside (NR) with
Choline and/or Betaine and/or DMG (all
forms)
3) To permit Buyer the
right to engage in the research, advertising, promotion,
manufacturing, packaging, shipment, distribution, use, offer for
sale, and sale of the NR-Choline-Betaine-DMG Combination
Product or of Derivatives of the NR-Choline-Betaine-DMG Combination
Product
4) Derivatives of the
NR-Choline-Betaine-DMG
Combination
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Product
are defined as any product that contains the NR-Choline-Betaine-DMG Combination in
combination with any other ingredient(s)
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-1-
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Exclusivity
in the Territory
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1) Xxxxxx
retains exclusivity for stand-alone NR in the Licensed Health Care Professionals
Channel in North America.
2) Xxxxxx
obtains Exclusive Supply of NR-Choline-Betaine-DMG
Combination
3) Xxxxxx
retains Non-exclusive right for NR combined with any form of
folate or B12.
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Exclusivity
Requirements
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Exclusivity in the
Territory will be maintained if between the Effective Date of the
First Amendment and September 9, 2015, the Buyer purchases a
minimum […***…] dollars
($[…***…]) of Product ([…***…]kg at
$[…***…]/kg) and a minimum of […***…]
dollars ($[…***…]) of the Product at a price of
$[…***…]kg in the third year of the contract with Year
3 to begin on October 1, 2015. Buyer shall place binding quarterly
POs in Year 3 for at least $[…***…] of Product to
maintain exclusivity.”
1) Product Launch
Requirements: Xxxxxx Research has 1 year to launch the NR-Choline-Betaine Combination Product
and 1½ years to
launch Choline and/or
Betaine and/or
dimethylglycine (DMG)
2) Clinical Study
Requirements: Xxxxxx will start a human clinical study within 6
months of signing this Term Sheet.
Ownership of all
Property will be transferred to ChromaDex if above requirements are
not met. On a confidential basis, ChromaDex shall access to all
data and reports generated from the Clinical Study.
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Technology
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Formulations of the
NR-Choline-Betaine-DMG
Combination Product or of Derivatives of the NR-Choline-Betaine-DMG Combination
Product.
Form of
Choline to include all present and future forms of choline, which
presently includes, but is not limited to:
Choline
citrate (Citicholine)
Choline
bitartrate
Phosphatidylcholine
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*** Confidential Treatment
Requested
-2-
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alpha-GPC (L-Alpha
Glycerylphosphorylcholine)
CDP
Choline (cytidine 5′-diphosphocholine)
Form of
Betaine to include all present and future forms of betaine, which
presently includes, but is not limited to:
Betaine
monohydrate
Betaine
anhydrous
Trimethylglycine
(TMG)
Forms
of Dimethylglycine (DMG) to include all present and future forms of
DMG
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Territory
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1) Retain
Licensed Health Care
Professionals channel in North America for stand-alone
NR
2) North
America for NR-Choline-Betaine-DMG
Combination with a right of first refusal for other
countries.
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Field
of Use
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Human
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-3-
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Channel
of Distribution
(“Channel”)
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1) Xxxxxx
retains the exclusive right to engage in the research, advertising,
promotion, manufacturing, packaging, shipment, distribution, use,
offer for sale, and sale of the Nicotinamide Riboside Product or of
Derivatives of the Nicotinamide
Riboside Product in the Channel defined as Licensed Health Care Professionals
2) This
addendum governs Xxxxxx’x right to engage in the research,
advertising, promotion, manufacturing, packaging, shipment,
distribution, use, offer for sale, and sale of the NR-Choline-Betaine-DMG Combination or of
Derivatives of the NR-Choline-Betaine-DMG Combination
across all Channels in the Territory , with the exception of
channels in which ChromaDex has already granted or grants
exclusivity to third parties as set forth below. In those channels,
Xxxxxx is prohibited from selling any product containing NR
(NIAGEN®).
3) ChromaDex
is currently selling the Product to customers that market and sell
multi-vitamins containing the Product and will continue to pursue
relationships with such parties. These multi-vitamins contain a
multitude of ingredients, including Choline, Betaine, and DMG.
However, in all channels, other ChromaDex NR Buyers would be excluded from
marketing the NR-Choline-Betaine-DMG Combination,
according to the following guidelines:
Amounts of Choline, TMG, or DMG in
Relation to the Nicotinamide Riboside Content Permitted in Products
Marketed & Sold by Non-Xxxxxx Vendors§
 *Refers
to the Total Daily Dose of methyl donors in aggregate. Individual
amounts of choline, TMG, or DMG to be added are at the
vendor’s discretion, with the total of any combination
thereof to not exceed the amount listed in the table.Xxxxxx shall
not unreasonably deny ChromaDex’s reasonable request for an
exception to the above guidelines.
4) ChromaDex
NR Buyers would also be excluded from marketing, offering for sale,
or selling the NR-Choline-Betaine-DMG Combination with
“methyl donor” claims, with the methylation message, or
by describing such relationship between NR, choline, betaine,
and/or NR. Further, ChromaDex NR Buyers would be excluded from
marketing, offering for sale, or selling NR-Choline-Betaine-DMG Combination with
reference to any published clinical studies using the NR-Choline-Betaine-DMG Combination. Both
Parties agree to monitor violations of this clause and ChromaDex
will use best efforts to enforce any violations of this
clause.
5) Any
subsidiary rights to use the NR-Choline-Betaine-DMG Combination would
have to be obtained through Xxxxxx Research, Inc. and would be done
so at the sole discretion of Xxxxxx Research, Inc.
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Current
Exclusions to Sale of Product
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1) Excluded
products include energy shots or melts (melting or dissolvable
tablet or delivery system)
2) Excluded
Fields/Channels: The “Multi-Level Marketing Channel”
defined as the sale of products through a network of independent
marketing representatives and the “Direct Response
Channel” defined as the marketing and advertising of the
Product through direct response television and radio advertisements
of any length or format intended to reach one or more potential
consumers asking them to purchase from or respond directly to Buyer
or its agent via a website, telephone number, or other medium to
purchase.
3) Channels/Fields/Products
may be excluded at any time at the sole discretion of Seller upon
written notice, unless the Parties have previously agreed in
writing that such channel/field/product may not be excluded because
Buyer has demonstrated established sales of or other commitment to
a specified channel/field/product.
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What is
Covered by the Addendum
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Commensurate with
the Original Agreement
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Property
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Trademarks,
patents, data, trade secrets, science, technology, formulas,
know-how, intellectual property, clinical research data (including
data generated by Xxxxxx), or other information relating to any
NR-Choline-Betaine-DMG
Combination Product
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Registration
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The
parties will determine responsibilities for registration in the
appropriate jurisdictions
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Regulatory
Category
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1) Dietary
supplements
2) Xxxxxx
Research also obtains the right to co-market the NR-Choline-Betaine-DMG Combination with
specific drugs (drugs, OTC drugs, or botanical drugs) approved for
specific diseases or conditions
3) Xxxxxx
Research further expresses its interest to pursue the right to
develop the NR-Choline-Betaine-DMG
Combination AS a drug approved for specific diseases or
conditions. This can be governed by a first right of refusal in the
Original Agreement or governed by a separate agreement addressing
the NR-Choline prodrug
conjugate.
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Payment
Terms
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To be
determined
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-5-
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Royalties
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Same as
original agreement
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Research
Costs
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NA
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Marketing
Support
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Method
of marketing and marketing partners to be determined by the
parties
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Regulatory
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As
appropriate in all Territories, Fields of Use, &
Channels
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Assignment
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1) No
right to assign this Agreement, except as part of transfer of
a business unit or transfer of all the activities of one of the
Parties.
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Trademark
-
Supplier
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Nicotinamide
Riboside has been registered by the Supplier under the NIAGEN®
trademark. Trademarks on goods developed by Supplier will be
developed, filed, owned, and maintained by Supplier.
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Trademark
–
Buyer
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Xxxxxx
Research shall own the trademark/registration for the NR-Choline-Betaine-DMG Combination,
regardless of whether that occurs as a single product or the
NR-Choline-Betaine-DMG
Combination occurs as an ingredient in one or more finished
products. Trademarks on finished goods developed by Buyer will be
developed, filed, owned, and maintained by Xxxxx.
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Patent
Costs
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Each
Party shall bear its own patent filing and maintenance costs,
unless otherwise defined in writing by this or another
Agreement
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Patent
Filing
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Where
relevant to new innovation
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Patent
Defense Costs
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To be
commensurate with the Original Agreement:
1)
Supplier shall have the obligation and first right to defend patent
infringement claims against Nicotinamide Riboside
2)
Should Supplier default, see terms of Original
Agreement
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Milestones
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as
described in the table below.
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CHROMADEX,
INC.
XXXXXX
RESEARCH, Inc.
/s/ Xxxxx
Xxxxxx
/s/ Xxxx
Xxxxxxxx
Name: Xxxxx
Xxxxxx
Name: Xxxx Xxxxxxxx
Title:
CEO
Title: CEO
Date:
July 24,
2015
Date: July 24, 2015
-6-
Discovery
Timeline for NR-Choline-Betaine-DMG
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Milestone
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1
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2
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3
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4
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Human
Clinical
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KGK 24 hour
Pharmacokinetics Trial at 100, 300, and 1000 mg
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U
Copenhagen 24 hour Pharmacokinetics Trial at X mg
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KGK Two Month
NAD Molecular Network Trial
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Safety/
Toxicology
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Yes;
serum chemistry; blood cell response
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Yes;
serum chemistry; blood cell response
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Yes;
serum chemistry; blood cell response
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Pharmacokinetics
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NAD
Methylnicotinamide
Betaine
Choline
Homocysteine
Nuclear
uracil
NAD
metabolic network
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NAD
Methylnicotinamide
Betaine
Choline
Homocysteine
Nuclear
uracil
NAD
metabolic network
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NAD
Methylnicotinamide
Betaine
Choline
Homocysteine
Nuclear
uracil
NAD
metabolic network
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Legal
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Oringinal
Agreement Governing NR+Choline and/or Betaine and/or
DMG
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Evaluate M2
results
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Evaluate M3
results
Report
& acceptance of M2 results
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Evaluate M4
results
Report
& final acceptance of M2-4 results
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Strategic
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Exclusivity
around the key methyl donors choline and betaine
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Begin
dose determination for choline, betaine, or DMG
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Continue dose
determination for choline, betaine, or DMG
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Final
determination of Begin dose determination for choline, betaine, or
DMG
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Completion
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7.10.15
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Complete
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9.20.15
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11.20.15
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Study
Cost
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XXX
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XXX
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TBD
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Milestone
Cost
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$0k
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Schedule of Milestones and Costs
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