Exhibit 10.1
SUPPLY AND DISTRIBUTION AGREEMENT
THIS AGREEMENT, entered into the 15th
day of November, 2007, by and between Neoprobe Corporation, a
Delaware corporation having a place of business at 425 Metro Place
North, Suite 300, Dublin, Ohio 43017 (“Supplier”),
and Cardinal Health 414, LLC, a Delaware limited liability company,
having a place of business at 7000 Cardinal Place, Dublin, Ohio
43017 (“Cardinal Health”).
WHEREAS, Supplier intends to
manufacture and sell various radiopharmaceutical products,
including a product identified as Lymphoseek ® , as
hereinafter described in greater detail (the
“Product”); and
WHEREAS, Cardinal Health desires to
purchase from Supplier on an exclusive basis, and Supplier desires
to manufacture and sell to Cardinal Health on an exclusive basis
within the Territory, the Product on the terms and conditions
hereinafter set forth;
NOW, THEREFORE, in consideration of
the mutual covenants and agreements contained in this Agreement,
the parties mutually agree as follows:
1.
DEFINITION OF TERMS
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1.1 |
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“Affiliate(s)” means any corporation, firm,
partnership or other entity that controls, is controlled by or is
under common control with a party. For purposes of this definition,
“control” shall mean the ownership of at least fifty
percent (50%) of the voting share capital of such entity or any
other comparable equity or ownership interest. |
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1.2 |
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“Applicable Laws” means all laws, ordinances, rules
and regulations applicable to the Product or any aspect thereof and
to the obligations of Cardinal Health or Supplier, as the context
requires, under this Agreement, including, without limitation,
(a) all applicable federal, state and local laws and
regulations, (b) the U.S. Food, Drug and Cosmetic Act (21
U.S.C. §201, et seq.), and (c) the current Good
Manufacturing Practices promulgated by the FDA, each as amended
from time to time. |
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1.3 |
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“Contract Year” means four calendar quarters
beginning with the first calendar quarter following the Effective
Date, and each twelve (12) month period beginning with the
corresponding month in subsequent calendar years. Contract Year 1
shall also include the also include those days prior to the first
calendar quarter following the Effective Date. |
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1.4 |
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“Effective Date” means the date of approval by the
FDA of a New Drug Application for the Product. |
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1.5 |
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“FDA” means the U.S. Food and Drug
Administration. |
*
Portions have been omitted and filed separately with the Securities
and Exchange Commission pursuant to a request for confidential
treatment.
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1.6 |
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“Procedure” means a single diagnostic procedure
(specifically, a single surgical or preoperative imaging
application of Sentinel Lymph Node Biopsy) for which the Product is
dispensed by Cardinal Health for administration to a single
patient. |
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1.7 |
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“Product” shall mean Lymphoseek, as more
specifically described in Schedule 1.7 , which is
incorporated into this Agreement. |
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1.8 |
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“Provisional Transfer Cost” means (a) through
the end of the first Contract Year, [*] per Vial delivered to
Cardinal Health, and (b) beginning with the second Contract
Year and continuing thereafter during the Term, the dollar amount
per Vial that is equal to the greater of (i) [*] percent ([*]%) of
the average retail sales price of the Product per Procedure by
Cardinal Health during the prior Contract Year, or (ii) [*] Dollars
([*]) per Vial delivered to Cardinal Health. |
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1.9 |
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“Revenue” means the sales revenue received by
Cardinal Health, net of any rebates, returns, credits and
allowances, resulting directly from the sale of the Product. |
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1.10 |
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“Revenue Share Amount” means the dollar amount due
to Supplier that is equal to Revenue multiplied by the applicable
percentage set forth on Schedule 1.10 , but only to the
extent such amount exceeds the Provisional Transfer Cost paid to
Supplier by Cardinal Health. |
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1.11 |
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“Specifications” shall mean the manufacturing,
labeling and packaging specifications defined in an FDA New Drug
Application for the Product. |
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1.12 |
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“Term” means the duration of this Agreement as set
forth in Section 2 below. |
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1.13 |
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“Territory” means the fifty states of the United
States of America. |
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1.14 |
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“Vial” shall mean one vial of the Product, as
further identified in Schedule 1.7. |
2. TERM
OF AGREEMENT
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2.1 |
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Unless earlier terminated pursuant to the terms herein, this
Agreement shall commence upon the date set forth in the first
paragraph hereof and shall continue in effect for a period of sixty
(60) months from the Effective Date. |
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2.2 |
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The Term of this Agreement will automatically renew for an
additional Contract Year (and shall continue to renew annually
thereafter), unless either party gives notice of non-renewal to the
other party at least six (6) months before the expiration of
the then-current Term. |
3.
EXCLUSIVE SALE AND PURCHASE OF THE PRODUCTS
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3.1 |
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Following the Effective Date, Supplier agrees to manufacture
and sell the Product exclusively to Cardinal Health in the
Territory, and Cardinal Health agrees to purchase the Product
exclusively from Supplier in the Territory in accordance with |
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*
Portions have been omitted and filed separately with the Securities
and Exchange Commission pursuant to a request for confidential
treatment.
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the provisions of this Agreement. Cardinal Health shall be
entitled to compound and distribute unit doses (i.e., prescriptions
for a single Procedure) to customers located within the Territory
for use within the Territory, and to distribute the Product in bulk
form to end-users or subdistributors located within the Territory
for use within the Territory, including, but not limited to,
hospitals, clinics and mobile imaging services; provided however
that (i) no such subdistributor may appoint any other
subdistributor, (ii) Cardinal Health assumes full
responsibility for compliance with all applicable restrictions and
obligations by each subdistributor, and (iii) all payments and
reports due on account of subdistributor activity will be made by
and through Cardinal Health together with Cardinal Health’s
other payments and reports. |
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3.2 |
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For purposes of calculating the Revenue Share Amounts below,
sales of Product in bulk form (i.e., not compounded) shall be
presumed to be on the basis of [*] per Vial. The volume, price and
ratio per vial of sales in bulk form will be reviewed periodically
by the Steering Committee and may be adjusted as deemed appropriate
by the Steering Committee. |
4.
REVENUE SHARE AMOUNT
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4.1 |
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Within thirty (30) days following the end of each month
during the Term, Cardinal Health shall provide to Supplier data on
the sales of the Product sufficiently detailed to allow Supplier to
calculate the number of Procedures performed and the applicable
Revenue Share Amount. |
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4.2 |
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Within forty-five (45) days following the end of each
calendar quarter of the Term, Cardinal Health will pay to Supplier
the Revenue Share Amount by annualizing the number of Procedures
sold during the applicable quarter (the “Quarterly Revenue
Share Amount”) and will provide to Supplier a report setting
forth in reasonable detail the basis for the calculation of the
Quarterly Revenue Share Amount. |
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4.3 |
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For each Contract Year, Cardinal Health shall calculate the
annual Revenue Share Amount due to Supplier (the “Annual
Revenue Share Amount”). If the Annual Revenue Share Amount is
less than the sum of the Quarterly Revenue Share Amounts paid
during the applicable Contract Year, Supplier shall refund the
excess to Cardinal Health within forty-five (45) days of
notice of such excess. If the Annual Revenue Share Amount is
greater than the sum of the Quarterly Revenue Share Amounts for the
applicable Contract Year, Cardinal Health shall remit the balance
due to Supplier within forty-five (45) days following the last
day of the applicable Contract Year. |
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4.4 |
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In the event the Provisional Transfer Cost of Vials used
related to Procedures sold during a given quarter exceeds the
amount calculated pursuant to Schedule 1.10 , Cardinal
Health shall be entitled to a credit against the Revenue Share
Amount due to Supplier in the next applicable period or periods in
the amount of such excess. However, for purposes of calculating the
Revenue Share Amount for the applicable |
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*
Portions have been omitted and filed separately with the Securities
and Exchange Commission pursuant to a request for confidential
treatment.
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period, in no case can the number of Vials used for any given
calendar quarter included in the calculation exceed the number of
Procedures sold in the calculation. |
5.
PROVISIONAL TRANSFER COST; SHIPMENT TERMS; MILESTONE PAYMENTS
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5.1 |
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The price to be paid for Vials of the Products purchased by
Cardinal Health under this Agreement shall be the Provisional
Transfer Cost. |
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5.2 |
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All prices are F.O.B. Cardinal Health’s national
radiopharmaceutical distribution center. |
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5.3 |
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Prices do not include any sales, use, excise or other similar
taxes or duties. Cardinal Health shall pay all such taxes and
duties and any personal property taxes or other similar charges
assessed on the Product after delivery to the carrier. |
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5.4 |
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Unless otherwise agreed by the parties in writing, Cardinal
Health shall make payment separately for each purchase order filled
by Supplier. Cardinal Health shall pay all invoice amounts within
thirty (30) days of the date of Cardinal Health’s
shipment of the Product from Cardinal Health’s national
distribution center to another point of destination (i.e., Cardinal
Health nuclear pharmacy or independent pharmacy). |
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5.5 |
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Title to and risk of loss or damage to the Product shall pass
to Cardinal Health on placement of Product in the hands of a
carrier for shipment from Cardinal Health’s national
distribution center to another point of destination. |
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5.6 |
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In addition to the Revenue Share Amount and Provisional
Transfer Cost, Cardinal Health shall pay to Supplier the following
payments (the “Milestone Payments”): |
(a) Upon Cardinal’s sale of [*]
cumulative Procedures, [*];
(b) Upon Cardinal’s sale of [*]
cumulative Procedures, [*];
(c) Upon Cardinal’s sale of [*]
cumulative Procedures, [*]; and
(d) Upon Cardinal’s sale of [*]
cumulative Procedures, [*].
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5.7 |
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Cardinal Health shall pay the applicable Milestone Payment
within forty-five (45) days of the end of the quarter in which
Cardinal Health achieves the applicable milestone Procedures amount
as set forth in Section 5.5. |
6.
ORDERING PROCEDURES; NO MINIMUM PURCHASE REQUIREMENT; MINIMUM SALES
REQUIREMENT
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*
Portions have been omitted and filed separately with the Securities
and Exchange Commission pursuant to a request for confidential
treatment.
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6.1 |
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Cardinal Health shall submit its orders for the Product through
Supplier’s Customer Service representative. Cardinal Health
may also submit orders by facsimile to (614) 793-7522. Each
order submitted by facsimile or in other written form must specify
(a) the number of Vials of the Product to be purchased and
(b) the desired delivery dates. Except for the information
specified in the preceding clauses (a) and (b), the terms of the
Cardinal Health’s purchase orders or any other documents
submitted by Cardinal Health shall be of no force and effect, and
the terms of such purchase and sale shall be governed solely by
this Agreement. |
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6.2 |
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Cardinal Health will provide Supplier with real-time electronic
access to inventory quantity and shipment information regarding
Product distributed from its national radiopharmaceutical
distribution center referenced in 5.2. |
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6.3 |
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Supplier will use reasonable commercial efforts to manufacture
and supply the Product in the amounts and at the times specified by
Cardinal Health. |
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6.4 |
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Cardinal Health has no obligation to purchase from Supplier any
minimum dollar volume of the Product, however, commencing with the
second Contract Year and, for each Contract Year thereafter,
Cardinal Health shall be required to sell not less than the greater
of (i) [*] percent ([*]%) of the number of Procedures sold during
the prior Contract Year or (ii) [*] Procedures (the “Minimum
Sales Requirement”). In the event Cardinal Health does not
meet the Minimum Sales Requirement for any Contract Year, within
thirty (30) days following the expiration of such Contract
Year, Cardinal must either (a) pay to Supplier the additional
Revenue Share Amount (based on the average sales price and
Procedure/Vial ratio that existed for the first three quarters of
the Contract Year) that Supplier would have earned if Cardinal
Health had met the Minimum Sales Requirement or (b) terminate
Supplier’s exclusivity obligation under this Agreement. |
7.
STEERING COMMITTEE; RETAIL PRICE
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7.1 |
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Cardinal Health and Supplier agree to establish a Steering
Committee comprised of an equal number of representatives from each
party. The Steering Committee will meet periodically, but no less
frequently than semi-annually. The Steering Committee shall be
responsible for reviewing performance and economics of the
distribution of the Product including, without limitation,
consideration of reimbursement rate, actual product labeling,
average selling price, number of Procedures per Vial, market
penetration and Supplier production forecasts. |
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7.2 |
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The Steering Committee will discuss and suggest the retail
sales price for the Product; provided however, that Cardinal Health
has sole discretion to establish the retail sales price and that
the Provisional Transfer Price per vial may not be decreased below
$[*] per Vial |
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8.
AUDIT RIGHTS
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8.1 |
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Each party (each such party, an “Obligated Party”)
agrees to permit the other party (each such party, an
“Auditing Party”) to appoint an independent certified
accountant, acceptable and approved by the Obligated Party, to
examine during reasonable business hours, upon ten
(10) business days prior written notice and not more
frequently than once each rolling twelve (12) calendar months,
the books and records of the Obligated Party only to the extent
necessary to verify compliance with this Agreement. The Auditing
Party shall make such examination at its sole cost and expense;
provided however, that in the event such audit reveals a material
breach of the Obligated Party’s obligations under this
Agreement, such Obligated Party shall bear the reasonable costs and
expenses of the audit. |
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8.2 |
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Unless otherwise agreed to by the Parties, if as a result of
the audit performed pursuant to Section 8.1, the independent
certified accountant determines that Cardinal Health has
under-reported any information necessary to calculate Revenue Share
Amount for the Product and as a result Supplier has received less
than it should have under the Agreement, Cardinal Health shall, no
later than forty-five (45) business days after receiving
notice of such underpayment, remit to Neoprobe the amount of the
underpayment. If as a result of the audit performed pursuant to
Section 8.1, the independent certified accountant determines
that Cardinal Health has over-reported any information used to
calculate the Revenue Share Amount for the Product and as a result
Supplier has received more than it should have under the Agreement,
Cardinal Health shall be entitled to a credit against the Revenue
Share Amount due to Supplier in the next applicable period in the
amount of such excess. |
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8.3 |
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The Auditing Party shall treat the information provided by the
Obligated Party as confidential information except that the
Auditing Party may disclose such information to its auditors,
accountants and attorneys to the extent reasonably necessary to
conduct such audit. |
9.
DUTIES OF CARDINAL HEALTH
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9.1 |
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In addition to all other obligations set forth in this
Agreement, Cardinal Health shall: |
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(a) |
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use diligent efforts to market the Product, including creating
promotional, educational, marketing and sales materials and a
marketing plan acceptable to the Supplier; provided that Supplier
may at its expense undertake certain promotional and/or marketing
activities; and |
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(b) |
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secure any governmental or regulatory approvals, at its own
expense, necessary for its purchase, use or resale of the Product
and provide proof of regulatory notification or approval as
requested by Supplier; and |
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(c) |
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comply at all times with all Applicable Laws governing the
performance of its obligations hereunder. |
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10.
DUTIES OF SUPPLIER
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10.1 |
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In addition to all other obligations set forth in this
Agreement, Supplier shall: |
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(a) |
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manufacture, label and package the Product in accordance with
the Specifications; |
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(b) |
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notify Cardinal Health promptly in writing should Supplier
become aware of any defect or condition which may render the
Product in violation of any Applicable Laws; and |
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(c) |
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comply at all times with all Applicable Laws |
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