Exhibit 10.1

 

Confidential Treatment – Asterisked material has been omitted and filed
separately with the Securities and Exchange Commission pursuant to a request for
confidential treatment.

 

MANUFACTURING SERVICES AGREEMENT

 

This MANUFACTURING SERVICES AGREEMENT ("Agreement") is made this 9th day of
September 2013, by and between OSO BioPharmaceuticals Manufacturing, LLC
(“OsoBio”), with a place of business at 4401 Alexander Blvd., Albuquerque, NM
87107, USA and Navidea Biopharmaceuticals, Inc. (“Navidea”), having its
principal place of business at 425 Metro Place North, Suite 450, Dublin, Ohio
43017, USA.

 

A.OsoBio provides contract pharmaceutical development, manufacturing, packaging,
analytical, and sales and marketing services to the pharmaceutical industry.

 

B.Navidea has certain technology relating to the certain pharmaceutical products
and wants OsoBio to assist in the formulation, filling, packaging and testing on
such products as provided in this Agreement and the attachments hereto.

 

C.Navidea desires to engage OsoBio to provide certain services to Navidea in
connection with the processing of Navidea's Product (defined below); and OsoBio
desires to provide such services pursuant to the terms and conditions set forth
in this Agreement.

 

NOW, THEREFORE, in consideration of the mutual covenants, terms and conditions
set forth below, the parties agree as follows:

 

ARTICLE 1

DEFINITIONS

 

The following terms have the following meanings in this Agreement:

 

1.1"Affiliate(s)" means any corporation, firm, partnership or other entity which
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.

 

1.2“API” means the active pharmaceutical ingredient used in the manufacture of
the Product.

 

1.3"Applicable Laws" means all laws, ordinances, rules and regulations within
the Territory applicable to the Processing of the Product or any aspect thereof
and the obligations of OsoBio or Navidea, as the context requires under this
Agreement, including, without limitation, (i) all applicable federal, state and
local laws and regulations of each Territory; (ii) the U.S. Federal Food, Drug
and Cosmetic Act, and (iii) the Good Manufacturing Practices promulgated by the
Regulatory Authorities, as amended from time to time (“GMPs”).

 

 

 

 

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1.4"Batch" means a specific quantity of a Product comprising a number of units
of Product mutually agreed upon between the parties, and that (a) is intended to
have uniform character and quality within specified limits, and (b) is Processed
according to a single manufacturing order during the same cycle of Processing.
Unless otherwise mutually agreed by both parties, Batch size shall mean the
targeted range of units used in the validation process, [*] vials.

 

1.5"Calendar Quarter" means a period of three (3) consecutive months commencing
on January 1, April 1, July 1 or October 1 of any calendar year.

 

1.6“Calendar Year” means the period from January 1 to December 31 of each year.

 

1.7“Certificate of Analysis” or “CofA” means a certificate providing details
about the quality and conformance to applicable quality assurance requirements
relating specifically to the result of testing a representative sample drawn
from the specific batch or lot of material it is purported to represent.

 

1.8“Change Order” shall have the meaning set forth in Section 4.5(a).

 

1.9“Commencement Date” means the first date upon which a Regulatory Authority
approves OsoBio as a manufacturer of one of the Products; provided that such
date shall not be earlier than the date that a Regulatory Authority has granted
marketing clearance for the Product.

 

1.10"Confidential Information" is as defined in Section 11.2.

 

1.11“Contract Year” means each consecutive twelve (12) month period beginning on
the Commencement Date.

 

1.12“Navidea Materials” shall have the meaning set forth in Article 12.

 

1.13“Defective Product” shall have the meaning set forth in Section 5.2.

 

1.14“Delayed Approval Fee” shall have the meaning set forth in Section 7.4.

 

1.15“Dispute” shall have the meaning set forth in Section 18.9.

 

1.16"Effective Date" means the date this Agreement was fully executed.

 

1.17“Facilities” means OsoBio’s facilities located in Albuquerque, New Mexico,
as set forth below:

 

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Manufacturing and Microbial Testing:

Inspection, Testing, Packaging and Storage: 4272 Balloon Park Rd NE 4401
Alexander Blvd NE Albuquerque, NM  87109 Albuquerque, NM  87107 Analytical
Testing: Stability Testing:

4200 Balloon Park Rd NE

Albuquerque, NM 87109

Not applicable to OsoBio.

 

[*]

 

1.18“FDA” means the United States Food and Drug Administration, and any
successor agency thereto.

 

1.19“Firm Commitment” shall have the meaning set forth in Section 4.2.

 

1.20“Intellectual Property” means all intellectual property (whether or not
patented), including without limitation, patents, patent applications, know-how,
trade secrets, copyrights, trademarks, designs, concepts, technical information,
manuals, standard operating procedures, instructions or specifications.

 

1.21“Minimum Requirement” shall have the meaning set forth in Section 4.1.

 

1.22“OsoBio Materials” shall have the meaning set forth in Article 12.

 

1.23"Process" or "Processing" shall mean the compounding, filling, producing,
packaging and labeling of the Raw Materials into Product in accordance with the
Specifications and the terms and conditions set forth in the Quality Agreement.

 

1.24"Processing Date" means the day on which the Product is to be first
Processed by OsoBio.

 

1.25“Product" means the product identified by the Specifications which may
include unlabeled lyophilized vialed product and labeled kits of finished
Lymphoseek® product.

 

1.26“Purchase Order” shall have the meaning set forth in Section 4.3.

 

1.27“Raw Materials” means all raw materials, supplies, components, labeling and
packaging necessary to manufacture and ship the Product in accordance with the
Specifications, as provided in Exhibit A, but not including the API.

 

1.28“Regulatory Approval” shall have the meaning set forth in Section 7.4.

 

1.29"Regulatory Authority" means any governmental regulatory authority within
the Territory involved in regulating any aspect of the development, manufacture,
market approval, sale, distribution, labeling, and packaging or use of the
Product.

 

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1.30“Release of Product to Navidea” means the posting of all documents required
for final Product release by Navidea. Posting is done by OsoBio via a mutually
agreed mechanism (i.e. secure electronic portal). This includes, but is not
limited to, relevant CofA’s, Batch records, and samples provided by OsoBio to
Navidea. For purposes of clarity, OsoBio does not perform final product release.

 

1.31“Review Period” shall have the meaning set forth in Section 5.1.

 

1.32“Rolling Forecast” shall have the meaning set forth in Section 4.2.

 

1.33“Sample” shall have the meaning set forth in Section 5.1.

 

1.34“Specifications” means the Product specifications set forth on Exhibit A,
and any procedures, requirements, standards, quality control testing, or any
provisions of the Service Agreements that would impact Product quality.

 

1.35"Term" shall have the meaning set forth in Section 15.1.

 

1.36“Territory” shall mean the United States of America, those countries
regulated by the European Medicines Agency (EMA), and any other country that the
parties agree in writing to add to this Agreement from time to time.

 

1.37“Unit Pricing" shall have the meaning set forth in Section 7.1.

 

1.38“Validation Batches” shall mean each Batch of Product manufactured by OsoBio
which is necessary to support the validation portion of Navidea’s NDA submission
to the FDA.

  

ARTICLE 2

VALIDATION, PROCESSING & RELATED SERVICES

 

2.1           Validation Services. OsoBio shall perform the qualification,
validation and stability services described in Exhibit A, and Exhibit B of this
Agreement.

 

2.2           Supply and Purchase of Product. During the Term, OsoBio shall be
the primary supplier of manufacturing services for the Product and shall Process
the Products in accordance with the Specifications, the Applicable Laws and the
terms and conditions of this Agreement. Navidea shall purchase the Product from
OsoBio in accordance with the terms and conditions of this Agreement.

 

2.3           Other Related Services. OsoBio shall provide other services upon
terms and conditions agreed to by the parties in writing from time to time.

 

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ARTICLE 3

MATERIALS

 

3.1           API. Navidea shall supply to OsoBio for Processing, at Navidea's
sole cost, the API and applicable reference standards in quantities sufficient
to meet Navidea's requirements for each Product as further set forth in Article
4. Prior to delivery of any of the API or reference standard to OsoBio for
Processing, Navidea shall provide to OsoBio a copy of the API Material Safety
Data Sheet (“MSDS”), as amended, and any subsequent revisions thereto. Navidea
shall supply the API, reference standards, and Certificate of Analysis F.C.A.
(Incoterms 2010) the Facilities no later than sixty (60) days before the
scheduled Processing Date upon which such API will be used by OsoBio. Upon
receipt of the API, OsoBio shall conduct testing of the API according to the
specifications as agreed to by both parties. OsoBio shall use the API solely and
exclusively for Processing under this Agreement.

 

3.2           Raw Materials. OsoBio shall be responsible for procuring,
purchasing, inspecting and releasing adequate Raw Materials, at OsoBio’s cost,
as necessary to meet the Firm Commitment, unless otherwise agreed to by the
parties in writing. Raw materials may be purchased only from qualified
suppliers. Navidea will be responsible for all costs associated with
qualification of a supplier of a Raw Material designated by Navidea not
previously qualified by OsoBio. Unless a particular Raw Material can be replaced
with the same raw material from another supplier, OsoBio shall not be liable for
any delay in delivery of Product if (i) OsoBio is unable to obtain, in a timely
manner, a particular Raw Material necessary to Process the Product, and (ii)
OsoBio placed orders for such Raw Materials promptly following receipt of
Navidea’s Firm Commitment.

 

3.3           Artwork and Packaging. Navidea shall provide or approve, prior to
the procurement of applicable components, all artwork, advertising and packaging
information necessary to Process the Product. Such artwork, advertising and
packaging information is and shall remain the exclusive property of Navidea, and
Navidea shall be solely responsible for the content thereof. Such artwork,
advertising and packaging information or any reproduction thereof may not be
used by OsoBio following the termination of this Agreement, or during the Term
of this Agreement in any manner other than solely for the purpose of performing
its obligations hereunder.

 

3.4           Reimbursement for Materials. In the event of (i) a Specification
change for any reason, (ii) termination or expiration of this Agreement (other
than a termination by Navidea under Section 15.2); or (iii) obsolescence of any
Raw Material, Navidea shall bear the cost of any unused Raw Materials, provided
that OsoBio purchased such Raw Materials in quantities consistent with the first
six months of Navidea’s Rolling Forecast and any minimum purchase obligations
required by the Raw Material supplier.

 

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ARTICLE 4

MINIMUM COMMITMENT, PURCHASE ORDERS & FORECASTS

 

4.1          Minimum Requirement. During the term of the Agreement Navidea shall
purchase from OsoBio a minimum of [*] of its annual requirements for Product.

 

4.1.1 In the event that annual quantities do not exceed [*] Batches in Calendar
Year for which Navidea qualifies an additional contract manufacturer, the
minimum requirement of this Section 4.1 will be waived for said Calendar Year.

 

4.1.2 In the event (a) OsoBio fails to deliver Product for more than two
consecutive Calendar Quarters for which such Product had been ordered and firm
Purchase Order accepted by OsoBio in accordance with the requirements of Section
4.2 and such failure shall not be attributable to (i) any failure of performance
by Navidea of any of its obligations under this agreement or (ii) force majeure,
or (b) without limiting any rights under Section 15.2(a), OsoBio otherwise fails
to cure any of its other material noncompliance with the terms of this Agreement
within 180 days of formal notification of such non-complaince, Navidea shall be
released from the minimum requirement of this Section 4.1 for the remainder of
the Term.

 

4.1.3 At the end of each calendar year Navidea shall provide a statement of
compliance with this Section 4.1 as outlined in Exhibit D.

 

4.2          Forecast and Purchase Order. On or before the first (1st) day of
each Calendar Quarter, beginning at least one (1) Calendar Quarter prior to the
anticipated Commencement Date, Navidea shall furnish to OsoBio a written twelve
(12) month rolling forecast of the quantities of Product that Navidea intends to
order from OsoBio during such period ("Rolling Forecast"). The first six (6)
months of such Rolling Forecast shall constitute a firm and binding commitment
to order for the quantities of Product specified therein ("Firm Commitment") and
the following six (6) months of the Rolling Forecast shall be non-binding, good
faith estimates. Navidea shall submit with the Rolling Forecast a binding,
non-cancelable purchase order for the Firm Commitment portion of the Processing,
which specifies the actual number of Batches to be Processed, the approximate
number of vials in each Batch, and the specific requested delivery dates for
each Batch ("Purchase Order"). Navidea shall submit each Purchase Order to
OsoBio at least ninety (90) days in advance of the Processing Date requested in
the Purchase Order. OsoBio shall notify Navidea in writing of acceptance each
Purchase Order within ten (10) days of receipt; provided that OsoBio shall not
be permitted to reject any Purchase Order unless such Purchase Order is not
consistent with the terms of this Section 4.2 (i.e., not consistent with the
applicable Firm Commitment amount or the ninety (90)-day lead time). If within
the ten (10)-day period after receipt of a Purchase Order OsoBio does not
provide its notice of acceptance or rejection to Navidea, then the Purchase
Order shall be deemed to be accepted. In the event of a conflict between the
terms of any Purchase Order and this Agreement, this Agreement shall control
unless OsoBio has accepted such conflicting terms in the written notice of
acceptance referenced in the preceding sentences. Notwithstanding the foregoing,
OsoBio shall use commercially reasonable efforts to supply Navidea with
quantities of Product which are in excess of the quantities specified in the
Firm Commitment, subject to OsoBio's other supply commitments and manufacturing
and equipment capacity. Except as otherwise provided in this Section 4.2, no
modification or amendment to this Agreement shall be effected by or result from
the receipt, acceptance, signing or acknowledgement of any party’s purchase
orders, quotations, invoices, shipping documents or other business forms
containing terms or conditions in addition to or different from the terms and
conditions set forth in this Agreement.

 

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4.4           OsoBio’s Cancellation of Purchase Orders. In the event Navidea
refuses or fails to make scheduled deliveries of the API as provided in Section
3.1, OsoBio reserves the right to cancel all, or any part of, a Purchase Order
upon written notice to Navidea and OsoBio shall have no further obligations or
liability with respect to such Purchase Order.

 

4.5           Unplanned Delay or Elimination of Processing. OsoBio shall use
diligent efforts to meet the Purchase Orders; provided that the foregoing shall
not limit OsoBio’s obligation to deliver Product on the delivery date specified
in the relevant Purchase Order, nor Navidea’s remedies in the event of a breach
of such obligation under the terms and conditions of this Agreement. OsoBio
shall provide Navidea with as much advance notice as possible (and will use its
best efforts to provide at least fifteen (15) days advance notice where
possible) if OsoBio determines that any Processing will be delayed or eliminated
for any reason.

 

ARTICLE 5

TESTING; SAMPLES; RELEASE

 

5.1           Sample; Testing; Acceptance. Prior to delivering any shipment of
Product, OsoBio shall provide Navidea with a certificate of conformance and,
additionally, in cases where OsoBio has performed any analytical testing of the
Product, a Certificate of Analysis, in each case certifying that the Product
conforms in all material respects to the Specifications and Applicable Laws.
Navidea shall notify OsoBio within thirty (30) days following delivery of
Product (or, in the case of any nonconformity not reasonably susceptible to
discovery upon receipt of the Product, within 30 days after discovery thereof by
Navidea, but in no event after the expiration date of the Product) to Navidea if
Navidea has determined that such Product does not conform to Specifications or
Applicable Laws and shall provide OsoBio a sample of such non-conforming
Product. OsoBio shall have 10 days to advise Navidea in writing if it disagrees
with Navidea’s claimed nonconformity. If OsoBio agrees that the Batch is
non-conforming, OsoBio shall, at its option, promptly re-perform the services in
accordance with this Article, or credit Navidea’s account for the invoiced price
for such Product. If OsoBio does not agree with Navidea's determination that
such Product fails to meet the Specifications or Applicable Laws, then after
reasonable efforts to resolve the disagreement, either party may submit a sample
of such Product to a mutually agreed upon independent third party laboratory to
determine whether the Product meets the Specifications and Applicable Laws. The
independent party’s results shall be final and binding. In the event that such
evaluation determines that the Product does not conform to the Specifications or
Applicable Laws, OsoBio shall credit Navidea’s account for the invoiced price of
such Product. Unless otherwise agreed to by the parties in writing, the costs
associated with such testing and review shall be borne by the non-prevailing
party.

 

5.2           Replacement of Defective Product. In accordance with the terms set
forth in this Agreement, OsoBio shall, at its option, either (i) replace, at its
sole expense, all Product that does not comply with the Specifications
(“Defective Product”) or (ii) credit Navidea’s account for the invoiced price of
such Defective Product. The obligation of OsoBio to replace Defective Product in
accordance with the Specifications or credit Navidea for such defective product
shall be Navidea’s sole and exclusive remedy under this agreement for Defective
Product and is in lieu of any other warranty, express or implied.

 

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5.3           Supply of Material for Replacement Product. In the event OsoBio
replaces Defective Product pursuant to Section 5.2, above, Navidea shall supply
OsoBio with sufficient quantities of the API at its sole cost as necessary for
OsoBio complete such replacement, notwithstanding Liability in Section 16.1.

 

ARTICLE 6

DELIVERY

 

6.1           Delivery. OsoBio shall tender the Product for shipment, F.C.A.
(Incoterms 2010) the Facility promptly following the Release of Product to
Navidea. Risk of loss or damage to the Product shall remain with OsoBio until
the Product is loaded on the carrier’s vehicle at the Facility, whereupon title
and risk of loss or damage shall transfer to Navidea. Navidea shall be
responsible for all costs associated with shipment of the Product. Navidea shall
designate carriers to ship the Product and then designate the priority of such
qualified carriers to OsoBio.

 

6.2           Failure to Take Delivery. If Navidea or its designated agent fails
to take delivery by the scheduled delivery date, or within 2 weeks of OsoBio’s
release to Navidea, whichever is later, Navidea shall be invoiced on the last
day of each month for the stored Product and reasonable administration and
storage costs. For each such Batch, or portion of a Batch, of undelivered
Product, Navidea agrees that: (i) Navidea has made a fixed commitment to
purchase such Product, (ii) risk of ownership for such Product passes to
Navidea, (iii) such Product shall be on a bill and hold basis for legitimate
business purposes, (iv) if no delivery date is determined at the time of
billing, OsoBio shall have the right to ship the Product to Navidea within four
months after billing, and (v) Navidea will be responsible for any decrease in
market value of such Product that relates to factors and circumstances outside
of OsoBio’s control. Within five (5) days following a written request from
OsoBio, Navidea shall provide OsoBio with a letter confirming items (i) through
(v) of this Section for each Batch of undelivered Product.

 

ARTICLE 7

PRICING AND PAYMENT

 

7.1           Pricing. Navidea shall pay to OsoBio the unit pricing set forth on
Exhibit B (“Unit Pricing”) for all Product. In addition, Navidea shall pay
OsoBio for certain regulatory support services as set forth on Exhibit B. In the
event Navidea requests any other services, OsoBio shall provide a written quote
of the fee for such additional services and Navidea shall advise OsoBio whether
it wishes to have such additional services performed by OsoBio.

 

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confidential treatment.

 

7.2           Price Increase. OsoBio may implement an increase in the Unit
Pricing for the Product once annually in accordance with the total percentage
change in the Producer Price Index, Pharmaceutical Preparations (Series ID
PCU325412325412) as published by the U.S. Department of Labor, Bureau of Labor
Statistics (“PPI”) over the twelve (12) month period preceding the date of such
price increase, provided, however that, notwithstanding the actual change in the
PPI, if OsoBio’s cost for any Raw Material changes by more than five percent
(5%), OsoBio shall modify the Unit Pricing to account for such cost
differential. In the event of an increase tied to a change in OsoBio’s cost of
Raw Materials, OsoBio shall provide Navidea copies of invoices evidencing the
increased cost of such Raw Materials. Notwithstanding the foregoing, OsoBio
shall not increase the Unit Price more frequently than once in any twelve (12)
month period and may not increase the Unit Price for any undelivered Product
that is the subject of a Purchase Order issued within the preceding twelve (12)
months.

 

7.3           Taxes; Duty. All taxes, duties and other amounts assessed on the
Raw Materials, API or the Product prior to or upon sale to Navidea are the
responsibility of Navidea, and Navidea shall reimburse OsoBio for any such
taxes, duties or other expenses paid by OsoBio.

 

7.4           Product Approval. Notwithstanding the terms set forth above,
Navidea shall use its commercially reasonable efforts to expedite and obtain all
regulatory approvals necessary for OsoBio to commence production at the Facility
(“Regulatory Approvals”).

 

7.5           Payment Terms. OsoBio shall invoice Navidea for all Product upon
shipment of the Product pursuant to Section 6.1, and payment for such invoices
shall be due within thirty (30) days after the date of such invoice. Each such
invoice shall, to the extent applicable, identify the Purchase Order number,
quantities, Unit Price, freight charges, and the total amount to be remitted by
Navidea. Navidea shall pay all undisputed invoices within 30 days of the date of
the invoice. Any undisputed amounts not paid by Navidea when due under this
Agreement, shall accrue interest at the rate of one and one-half percent (1½%)
per month until paid in full.

 

ARTICLE 8

CHANGES TO SPECIFICATIONS

 

All Specifications and any changes thereto agreed to by the parties from time to
time shall be in writing, dated and signed by the parties. No change in the
Specifications shall be implemented by OsoBio, whether requested by Navidea or
requested or required by any Regulatory Authority, until the parties have agreed
in writing to such change, the implementation date of such change, and any
increase or decrease in fees associated with such change. OsoBio shall respond
promptly to any request made by Navidea for a change in the Specifications, and
both parties shall use commercially reasonable, good faith efforts to agree to
the terms of such change in a timely manner. As soon as possible after a request
is made for any change in Specifications, OsoBio shall notify Navidea of the
fees associated with such change. Navidea shall pay all fees associated with
such agreed upon changes.

 

ARTICLE 9

QUALITY & REGULATORY MATTERS

 

9.1           Quality Agreement. This Agreement hereby incorporates the Quality
Agreement between OsoBio and Navidea dated 11 April, 2013 as attached to this
Agreement as Exhibit C. The Quality Agreement shall in no way determine
liability or financial responsibility of the parties for the responsibilities
set forth therein. In the event of a conflict between the terms of this
Agreement and the Quality Agreement, this Agreement shall control except with
respect to matters relating to compliance with GMPs and related regulations, in
which case, the Quality Agreement will control.

 

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9.2           Regulatory Compliance. Navidea shall be solely responsible for all
permits and licenses required by any Regulatory Authority with respect to the
Product under this Agreement, including any product licenses, applications and
amendments in connection therewith. OsoBio will be responsible to maintain all
permits and licenses required by any Regulatory Authority with respect to the
Facility or the Processing of the Product. Each party intends and commits to
cooperate to satisfy all Applicable Laws relating to their activities under this
Agreement.

 

9.3           Regulatory Authority Inspection. OsoBio hereby agrees to advise
Navidea promptly, but not later than within two business days, of any proposed
or, scheduled or unannounced inspection of the Product or Processing by any
Regulatory Authority and will, to the extent not prohibited by Applicable Law,
permit Navidea to be present during any such inspection. If Navidea is not
present during such an inspection, OsoBio shall promptly provide a report of the
results of the inspection to Navidea.

 

9.4           Audit. Navidea or its designated representative shall have the
right during normal business hours, and upon reasonable notice to OsoBio, to
inspect and audit in a reasonable manner those portions of the Facilities in
which Processing is conducted in order to ensure OsoBio’s compliance with its
obligations under this Agreement.

 

9.5           Recall. In the event OsoBio believes a recall, field alert,
Product withdrawal or field correction may be necessary with respect to any
Product provided under this Agreement, OsoBio shall immediately notify Navidea
in writing. OsoBio will not act to initiate a recall, field alert, Product
withdrawal or field correction without the express prior written approval of
Navidea, unless otherwise required by Applicable Laws or upon advice of legal
counsel. In the event Navidea believes a recall, field alert, Product withdrawal
or field correction may be necessary with respect to any Product provided under
this Agreement, Navidea shall immediately notify OsoBio in writing and OsoBio
shall provide all necessary cooperation and assistance to Navidea. Navidea shall
bear the cost of, and shall reimburse OsoBio for expenses incurred in connection
with, any recall, field alert, Product withdrawal or field correction related to
the Product unless such recall, field alert, Product withdrawal or field
correction is caused primarily by OsoBio’s breach of its obligations under this
Agreement or Applicable Laws or its negligence or willful misconduct, in which
case, such cost shall be borne by OsoBio. For purposes hereof, such cost shall
be limited to reasonable, actual and documented administrative costs incurred by
Navidea for such recall, withdrawal or correction, and replacement of the
Defective Product to be recalled, in accordance with Article 5.

 

ARTICLE 10

REPRESENTATIONS, WARRANTIES AND COVENANTS

 

10.1         OsoBio. OsoBio represents, warrants and covenants to Navidea that:

 

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A. At the time of delivery of the Product as provided in Section 6.1, such
Product will conform to and will have been Processed in conformance with the
Specifications and Applicable Laws.

 

B. It has all necessary authority and all right, title and interest in and to
any Intellectual Property necessary to Process the Product or that is otherwise
required to perform its obligations under this Agreement.

 

C. It will comply with the Quality Agreement and all Applicable Laws during its
performance under this Agreement and its use of any materials or API provided by
Navidea under this Agreement.

 

D. It will obtain and maintain for each Facility all permits, licenses and
approvals required for OsoBio to Process and supply all Products in compliance
with the terms of this Agreement and all Applicable Laws.

 

E. It will not ship the Product if the batch record for a particular Batch of
Product indicates that the Product does not comply with the Specifications or
Applicable Laws, or if the Product has expired.

 

F. Prior to releasing any Batch of Product, it will review all Product specific
validation records and confirm that the Product is in compliance with Applicable
Laws.

 

G. All Products delivered to Navidea shall (1) comply with the specifications
and be produced in accordance with current Good Manufacturing Practices; (2) be
free and clear of any and all encumbrances, liens, security interests or other
third party claims; and (3) not be adulterated or misbranded within the meaning
of the U.S. Food, Drug and Cosmetic Act or any similar law or regulation of
applicable Regulatory Authorities.

 

H. It has not been debarred by the FDA or other Regulatory Authorities, and has
not been convicted of a crime that could lead to such debarment.

 

I. It will not employ, contract with or retain any person directly or indirectly
to perform services under this Agreement if such a person is debarred by the FDA
under 21 U.S.C. § 335(a) or disqualified as described in 21 C.F.R. §312.170. In
the event that OsoBio becomes aware of or receive notice of the debarment or
disqualification of any person providing services to under this Agreement, then
OsoBio agrees to notify Navidea immediately.

 

10.2        Navidea. Navidea represents and warrants to OsoBio that:

 

A.           The Navidea-supplied API will comply with all applicable
Specifications, will have been produced in compliance with the Applicable Laws;

 

B.           It has all necessary authority and all right, title and interest in
and to any Intellectual Property related to each Product or that is otherwise
required to perform its obligations under this Agreement;

 

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confidential treatment.

 

C.           All artwork and packaging provided by Navidea to OsoBio under
Section 3.3 shall comply with all Applicable Laws;

 

D.           It has provided all safe handling instructions, health and
environmental information and material safety data sheets applicable to the
Product or to the API, except as disclosed to OsoBio in writing by Navidea in
sufficient time for review and training by OsoBio prior to delivery;

 

E.           All Product delivered to Navidea by OsoBio will be held, used
and/or disposed of by Navidea in accordance with all Applicable Laws; and

 

F.           It will comply with all Applicable Laws applicable to Navidea’s
performance under this Agreement and its use of any materials or Products
provided by OsoBio under this Agreement.

 

G.           It will not release the Product if the batch record for a
particular Batch of Product indicates that the Product does not comply with the
Specifications or Applicable Laws.

 

H.           Prior to releasing any Batch of Product, it will review all Product
specific validation records and confirm that the Product is in compliance with
Applicable Laws.

 

10.3        Mutual. Each party hereby represents and warrants to the other party
that:

 

A.           Existence and Power. Such party (1) is duly organized, validly
existing and in good standing under the laws of the state in which it is
organized, (2) has the power and authority and the legal right to own and
operate its property and assets, and to carry on its business as it is now being
conducted, and (3) is in compliance with all requirements of Applicable Laws,
except to the extent that any noncompliance would not materially adversely
affect such party's ability to perform its obligations under the Agreement;

 

B.           Authorization and Enforcement of Obligations. Such party (1) has
the power and authority and the legal right to enter into this Agreement and to
perform its obligations hereunder and (2) has taken all necessary action on its
part to authorize the execution and delivery of this Agreement and the
performance of its obligations hereunder.

 

C.           Execution and Delivery. This Agreement has been duly executed and
delivered on behalf of such party, and constitutes a legal, valid, binding
obligation, enforceable against such party in accordance with its terms;

 

D.           No Consents. All necessary consents, approvals and authorizations
of all Regulatory Authorities and other persons required to be obtained by such
party in connection with the Agreement have been obtained; and

 

E.           No Conflict. The execution and delivery of this Agreement and the
performance of such party's obligations hereunder (1) do not conflict with or
violate any requirement of Applicable Laws; and (2) do not materially conflict
with, or constitute a material default or require any consent under, any
material contractual obligation of such party.

 

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confidential treatment.

 

10.4         Limitations. THE REPRESENTATIONS AND WARRANTIES SET FORTH IN THIS
ARTICLE 10 ARE THE SOLE AND EXCLUSIVE REPRESENTATIONS AND WARRANTIES MADE BY
EACH PARTY TO THE OTHER AND NEITHER PARTY MAKES ANY OTHER REPRESENTATIONS,
WARRANTIES OR GUARANTEES OF ANY KIND WHATSOEVER, INCLUDING WITHOUT LIMITATION
ANY IMPLIED WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A
PARTICULAR PURPOSE.

 

ARTICLE 11

CONFIDENTIAL INFORMATION

 

11.1         Mutual Obligation. OsoBio and Navidea agree that they will not
disclose the other party’s Confidential Information (defined below) to any third
party without the prior written consent of the other party except as required by
law, regulation or court or administrative order (including without limitation
the Securities Act of 1933, the Securities Exchange Act of 1934, and the
regulations promulgated thereunder); provided, however, that prior to making any
such legally required disclosure, the party making such disclosure shall give
the other party as much prior notice of the requirement for and contents of such
disclosure as is practicable under the circumstances. Notwithstanding the
foregoing, each party may disclose the other party’s Confidential Information to
any of its Affiliates that (A) need to know such Confidential Information for
the purpose of performing under this Agreement, (B) are advised of the contents
of this Article, and (C) agree to be bound by the terms of this Article. Each
receiving party shall use the disclosing party’s Confidential Information solely
for the purpose of carrying out the receiving party’s obligations under this
Agreement.

 

11.2         Definition. As used in this Agreement, the term “Confidential
Information” includes all such information furnished by OsoBio or Navidea, or
any of their respective representatives or Affiliates, to the other or its
representatives or Affiliates, whether furnished before, on or after the date of
this Agreement and furnished in any form, including but not limited to written,
verbal, visual, electronic or in any other media or manner. Confidential
Information includes all proprietary technologies, know-how, trade secrets,
discoveries, inventions and any other Intellectual Property (whether or not
patented), analyses, compilations, business or technical information and other
materials prepared by either party, or any of their respective representatives,
containing or based in whole or in part on any such information furnished by the
other party or its representatives. Notwithstanding the foregoing, Navidea
Confidential Information shall include the Process, all Master Batch Records,
and all Production Batch Records related to the manufacture and release of the
Product. Confidential Information also includes the existence of this Agreement
and its terms, provided that Navidea may disclose the existence of this
Agreement and its terms to a third party and/or the third party’s advisors in
connection with an investment in Navidea, acquisition of or merger with Navidea,
loan to Navidea, licensing transaction related to the Product or other
commercial agreement related to the sale, marketing or distribution of the
Product, provided that Navidea requires said third party to enter into a
confidentiality agreement on terms no less restrictive than those contained
herein and that Navidea also remains responsible for any disclosure by said
third party.

 

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confidential treatment.

 

11.3         Exclusions. Notwithstanding Section 11.2, Confidential Information
does not include information that (A) is or becomes generally available to the
public or within the industry to which such information relates other than as a
result of a breach of this Agreement, or (B) is already known by the receiving
party at the time of disclosure as evidenced by the receiving party’s written
records, or (C) becomes available to the receiving party on a non-confidential
basis from a source that is entitled to disclose it on a non-confidential basis,
or (D) was or is independently developed by or for the receiving party without
reference to the Confidential Information, as evidenced by the receiving party’s
written records.

 

11.4         No Implied License. The receiving party will obtain no right of any
kind or license under any Intellectual Property rights of a disclosing party by
reason of this Agreement. All Confidential Information will remain the sole
property of the party disclosing such information or data.

 

11.5         Return of Confidential Information. Upon termination of this
Agreement, the receiving party shall, upon request, promptly return within
thirty (30) days all such information, including any copies thereof, and cease
its use or, at the request of the disclosing party, shall promptly destroy the
same and certify such destruction to the disclosing party; except for a single
copy thereof, which may be retained for the sole purpose of determining the
scope of the obligations incurred under this Agreement.

 

11.6         Survival. The obligations of this Article 11 will terminate five
(5) years from the expiration of this Agreement.

 

ARTICLE 12

INTELLECTUAL PROPERTY

 

12.1 Rights in Materials. All OsoBio Materials, including without limitation,
all improvements, developments, derivatives or modifications to the OsoBio
Materials, shall be owned exclusively by OsoBio. All Navidea Materials,
including, without limitation, all improvements, developments, derivatives or
modifications to the Navidea Materials shall be owned exclusively by Navidea.
For purposes hereof, “OsoBio Materials” means all OsoBio proprietary
information, intellectual property, and developments (including, all patents,
patent applications, know-how, inventions, designs, concepts, improvements,
technical information, manuals, instructions or specifications), owned, licensed
or used by OsoBio in developing, formulating, manufacturing, filling, processing
or packaging of liquid solutions or pharmaceuticals and the packaging equipment,
processes or methods of packaging, or any improvements to any of the foregoing,
including any container, pouch, vial, ampoule or other form of liquid container
developed by OsoBio. For purposes hereof, “Navidea Materials” means all
proprietary information, intellectual property and developments owned,
developed, licensed or used by Navidea relating to the API and Product,
including, without limitation, patents, patent applications, know-how,
inventions, designs, concepts, improvements, technical information, trademarks
or trade names.

 

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confidential treatment.

 

12.2 Inventions. If OsoBio or its agents or employees make any invention,
improvement or modification (whether or not patentable) to the Product or the
use thereof (exclusive of methods of Processing) in the course of providing
services under this Agreement, OsoBio shall promptly disclose such invention,
improvement or modification to Navidea and assign and/or cause its agents or
employees to assign all rights, title and interest in such invention,
improvement or modification to Navidea. OsoBio shall execute such further
documents and take such further actions as are reasonable or necessary to fully
vest in Navidea such rights, title and interest.

 

ARTICLE 13

INDEMNIFICATION

 

13.1         Indemnification by OsoBio. Subject to the limitation of liability
provisions of Section 16, OsoBio shall indemnify and hold harmless Navidea, its
Affiliates, and their respective directors, officers, employees and agents
(“Navidea Indemnitees”) from and against any and all suits, claims, losses,
demands, liabilities, damages, costs and expenses (including reasonable
attorneys’ fees) in connection with any suit, demand or action by any third
party (“Losses”) arising out of or resulting from (A) any breach of its
representations, warranties or obligations set forth in this Agreement or (B)
any gross negligence or willful misconduct by OsoBio, except to the extent that
any of the foregoing arises out of or results from any Navidea Indemnitee’s
negligence, willful misconduct or breach of this Agreement.

 

13.2         Indemnification by Navidea. Navidea shall indemnify and hold
harmless OsoBio, its Affiliates, and their respective directors, officers,
employees and agents (“OsoBio Indemnitees”) from and against all Losses arising
out of or resulting from (A) any breach of its representations, warranties or
obligations set forth in this Agreement; (B) any manufacture, sale, promotion,
distribution, use of or exposure to the Product or any Navidea-supplied API, or
third-party sourced diluent, incorporated into the Product including, without
limitation, product liability or strict liability; (C) Navidea's exercise of
control over the Processing of the Product to the extent that Navidea's
instructions or directions violate Applicable Law; (D) any actual or alleged
infringement or violation by the API or Product of any third party Intellectual
Property rights provided by Navidea; or (F) any gross negligence or willful
misconduct by Navidea, except to the extent that any of the foregoing arises out
of or results from any OsoBio Indemnitee’s gross negligence, willful misconduct
or breach of this Agreement.

 

13.3         Indemnification Procedures. All indemnification obligations in this
Agreement are conditioned upon the party seeking indemnification: (A) promptly
notifying the indemnifying party of any claim or liability of which the party
seeking indemnification becomes aware (including a copy of any related
complaint, summons, notice or other instrument); provided, however, that failure
to provide such notice within a reasonable period of time shall not relieve the
indemnifying party of any of its obligations hereunder except to the extent the
indemnifying party is prejudiced by such failure; and (B) reasonably cooperating
with the indemnifying party in the defense of any such claim or liability (at
the indemnifying party's expense). The indemnifying party may, in its sole
discretion, assume and conduct the legal defense of the indemnified person in,
and the settlement of, any suit that could result in claims under this Section
13.3; provided, however , that the indemnifying party will not, in defense of
any such suit, except with the consent of the indemnified person, consent to the
entry of any judgment or enter into any settlement which does not include, as an
unconditional term thereof, the giving by the claimant or plaintiff to the
indemnified person of a release from all liability in respect thereof. If the
indemnifying party assumes the defense and settlement of a suit, the indemnified
person may elect to participate in, but not control, such defense and settlement
through counsel of its choosing and at its own expense.

 

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confidential treatment.

 

ARTICLE 14

INSURANCE

 

During the Term, each party shall, at its own cost and expense, obtain and
maintain in full force and effect the following insurance: (i) with respect to
OsoBio only, Commercial General Liability insurance with per-occurrence and
general aggregate limits of not less than [*]; (ii) Products and Completed
Operations Liability Insurance with per-occurrence and general aggregate limits
of not less than [*]; (iii) Workers’ Compensation and Employer’s Liability
Insurance with statutory limits for Workers’ Compensation and Employer’s
Liability insurance limits of not less than [*]; (iv) with respect to OsoBio
only, Professional Services Errors & Omissions Liability Insurance with per
claim and aggregate limits of not less than [*] covering sums that OsoBio
becomes legally obligated to pay as damages resulting from claims made by
Navidea for errors or omissions committed in the conduct of the services
outlined in the Agreement; and (v) with respect to Navidea only, All Risk
Property Insurance, including transit coverage, in an amount equal to full
replacement value covering Navidea’s property while it is at the Facility. In
the event that any of the required policies of insurance are written on a claims
made basis, then such policies shall be maintained during the entire Term and
for a period of not less than three (3) years following the termination or
expiration of this Agreement. Upon request of a party, the other party shall
furnish evidence of insurance for the above noted policies applicable to such
other party. Each insurance policy that is required under this Article 14 shall
be obtained from an insurance carrier with an A.M. Best rating of at least A-
VII.

 

ARTICLE 15

TERM AND TERMINATION

 

15.1        Term. This Agreement shall commence on the Effective Date and shall
continue until December 31, 2016, unless earlier terminated under Section 15.2
below (the "Term"). After December 31, 2016, this Agreement shall automatically
renew for additional two (2) year periods, unless written notice of intent to
cancel the agreement is provided by either party at least twelve (12) months
prior to the expiration of the initial term or any.

 

15.2        Termination by Either Party.

 

(a)          Material Breach. Either party may terminate this Agreement
effective upon sixty (60) days prior written notice to the other party, if the
other party commits a material breach of this Agreement and fails to cure such
breach by the end of such sixty (60) day period; provided, however, that failure
to pay all undisputed invoices under this Agreement within ninety (90) days
after such payments are due (as set forth in Section 8.5) shall constitute cause
for immediate termination of this Agreement, or at OsoBio’s discretion, OsoBio
shall be relieved of any further obligation to perform under this Agreement
until all outstanding payments are brought current.

 

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confidential treatment.

 

(b)          Bankruptcy. Either party may terminate this Agreement effective
upon written notice to the other party, if the other party becomes insolvent or
admits in writing its inability to pay its debts as they become due, files a
petition for bankruptcy, makes an assignment for the benefit of its creditors or
has a receiver, trustee or other court officer appointed for its properties or
assets.

 

15.3        Duties Upon Termination. In the event of any termination, other than
a termination by either party as a result of a material breach by the other,
OsoBio shall complete delivery of any Product in accordance with any Purchase
Order open as of the date notice of termination is given hereunder. In the event
of any termination, OsoBio shall promptly, after completion of any deliveries
required by the immediately preceding sentence, return to Navidea (i) any
remaining inventory of API or other materials received from Navidea or Navidea’s
suppliers, (ii) all packaging components paid for by Navidea, (iii) all
remaining inventories of the Product; and (iv) any Product or material being
stored for Navidea, at Navidea’s expense. OsoBio shall have no obligation to
return the foregoing until all outstanding invoices to Navidea have been paid in
full.

 

ARTICLE 16

LIMITATIONS OF LIABILITY

 

16.1        OSOBIO’S LIABILITY FOR ANY AND ALL CLAIMS FOR LOST, DAMAGED OR
DESTROYED API OR OTHER NAVIDEA-SUPPLIED MATERIALS, WHETHER OR NOT SUCH API OR
NAVIDEA-SUPPLIED MATERIALS ARE INCORPORATED INTO FINISHED PRODUCT OR DEFECTIVE
PRODUCT SHALL BE LIMITED TO [*].

 

16.2        OSOBIO’S TOTAL LIABILITY UNDER THIS AGREEMENT SHALL IN NO EVENT
EXCEED THE TOTAL FEES PAID BY NAVIDEA TO OSOBIO FOR THE SERVICES OR BATCH OF
PRODUCT GIVING RISE TO SUCH LIABILITIES, CLAIMS, OR OBLIGATIONS.

 

16.3        NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR INDIRECT,
INCIDENTAL, SPECIAL, PUNITIVE, EXEMPLARY OR CONSEQUENTIAL LOSSES, DAMAGES, COSTS
OR EXPENSES OF ANY NATURE WHATSOEVER ARISING OUT OF PERFORMANCE UNDER THIS
AGREEMENT, INCLUDING WITHOUT LIMITATION, LOSS OF REVENUES, PROFITS OR DATA, OR
PENALTIES ARISING UNDER THIRD PARTY CONTRACTS, WHETHER IN CONTRACT OR TORT, EVEN
IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 16.3 IS INTENDED TO LIMIT
OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER ARTICLE
13, OR DAMAGES AVAILABLE FOR BREACHES OF CONFIDENTIALITY OBLIGATIONS IN ARTICLE
11.

 

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separately with the Securities and Exchange Commission pursuant to a request for
confidential treatment.

 

ARTICLE 17

NOTICE

 

All notices and other communications hereunder shall be in writing and shall be
deemed given: (A) when delivered personally; (B) when delivered by facsimile
transmission (receipt verified); (C) when received or refused, if mailed by
registered or certified mail (return receipt requested), postage prepaid; or (D)
when delivered if sent by express courier service,

 

to the parties at the following addresses (or at such other address for a party
as shall be specified by like notice; provided, that notices of a change of
address shall be effective only upon receipt thereof):

 

To Navidea:   Navidea Biopharmaceuticals, Inc.     425 Metro Place North, Suite
450     Dublin, OH 43017     Attn.:  President     Facsimile:  (614) 793-7522  
    With a copy to:   Navidea Biopharmaceuticals, Inc.     425 Metro Place
North, Suite 450     Dublin, OH 43017     Attn.:  CFO     Facsimile:  (614)
793-7522       To OsoBio:   OSO BioPharmaceuticals Manufacturing, LLC     4401
Alexander Blvd. NE     Albuquerque, NM 87107     Attn: President/CEO    
Facsimile: (505) 923-1611       With a copy to:  

OSO BioPharmaceuticals Manufacturing, LLC

4401 Alexander Blvd. NE

    Albuquerque, NM 87107     Attn: Contracts Manager     Facsimile: (505)
923-1611

 

ARTICLE 18

MISCELLANEOUS

 

18.1         Entire Agreement; Amendments. This Agreement, including the
attachments, Project Plans and any amendments thereto, constitutes the entire
understanding between the parties and supersede any contracts, agreements or
understanding (oral or written) of the parties with respect to the subject
matter hereof. No term of this Agreement may be amended or modified except upon
written agreement signed by a duly authorized officer of each party, unless
otherwise expressly provided in this Agreement.

 

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separately with the Securities and Exchange Commission pursuant to a request for
confidential treatment.

 

18.2         Captions. The captions in this Agreement are for convenience only
and are not to be interpreted or construed as a substantive part of this
Agreement

 

18.3         Further Assurances. The parties agree to execute, acknowledge and
deliver such further instruments and to take all such other incidental acts as
may be reasonably necessary or appropriate to carry out the purpose and intent
of this Agreement.

 

18.4         No Waiver. Failure by either party to insist upon strict compliance
with any term of this Agreement in any one or more instances will not be deemed
to be a waiver of its rights to insist upon such strict compliance with respect
to any subsequent failure.

 

18.5         Severability. If any term of this Agreement is declared invalid or
unenforceable by a court or other body of competent jurisdiction, the remaining
terms of this Agreement will continue in full force and effect.

 

18.6         Independent Contractors. The relationship of the parties is that of
independent contractors, and neither party will incur any debts or make any
commitments for the other party except to the extent expressly provided in this
Agreement. Nothing in this Agreement is intended to create or will be construed
as creating between the parties the relationship of joint ventures, co-partners,
employer/employee or principal and agent.

 

18.7         Successors and Assigns. This Agreement will be binding upon and
inure to the benefit of the parties, their successors and permitted assigns.
Neither party may assign this Agreement, in whole or in part, without the prior
written consent of the other party, except that either party may, without the
other party's consent, assign this Agreement to an Affiliate or to a successor
to substantially all of the business or assets of the assigning company.

 

18.8         Governing Law. This Agreement shall be governed by and construed
under the laws of the State of Delaware, excluding its conflicts of law
provisions. The United Nations Convention on Contracts for the International
Sale of Goods shall not apply to this Agreement.

 

18.9         Alternative Dispute Resolution. If any dispute arises between the
parties relating to this Agreement, including the breach, termination or
validity thereof (“Dispute”), such Dispute shall be presented to the respective
presidents or senior executives of OsoBio and Navidea for their consideration
and resolution. All negotiations pursuant to the preceding sentence will be
confidential and shall be treated as compromise and settlement negotiations for
purposes of applicable rules of evidence. If such parties cannot reach a
resolution of the Dispute, then such Dispute shall be finally resolved by
binding alternative dispute resolution in accordance with the then existing
Rules for Non-Administered Arbitration of the CPR Institute for Dispute
Resolution, 366 Madison Avenue, New York, NY 10017 (“CPR Rules”) by three
independent and impartial arbitrators, of whom each party shall designate one,
with the third arbitrator appointed as provided in the CPR Rules. The
arbitration shall be governed by the Federal Arbitration Act, 9 U.S.C. §§1 et
seq. and judgment upon the award rendered by the arbitrator(s) may be entered by
any court having jurisdiction thereof, subject, however, to the right of a party
to appeal such award under the CPR Arbitration Appeal Procedure. . Arbitration
shall be conducted in the jurisdiction of the defendant party. Each party is
required to continue to perform its obligations under this Agreement pending
final resolution of any dispute arising out of or relating to this Agreement,
unless to do so would be impossible or impracticable under the circumstances,
and provided that the provisions of this Section 18.9 shall not be deemed to be
a waiver of any right of termination under Section 15.2. Notwithstanding
anything in this Section 18.9 to the contrary, the parties shall be entitled to
seek at any time during a Dispute injunctive relief or other equitable remedies
with respect to any Dispute from any court of competent jurisdiction.

 

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separately with the Securities and Exchange Commission pursuant to a request for
confidential treatment.

 

18.10         Prevailing Party. In any dispute resolution proceeding between the
parties in connection with this Agreement, tribunal shall have the authority to
award and apportion costs, including reasonable attorneys’ fees and other costs
incurred by the parties, taking into account the circumstances of the case, the
conduct of the parties during the proceeding, and the result.

 

18.11         Counterparts. This Agreement may be executed in one or more
counterparts, each of which will be deemed an original but all of which together
will constitute one and the same instrument. Any photocopy, facsimile or
electronic reproduction of the executed Agreement shall constitute an original.

 

18.12         Publicity. Neither party will make any press release or other
public disclosure regarding this Agreement or the transactions contemplated
hereby without the other party's express prior written consent, except as
required under applicable law or by any governmental agency, in which case the
party required to make the press release or public disclosure shall use
commercially reasonable efforts to obtain the approval of the other party as to
the form, nature and extent of the press release or public disclosure prior to
issuing the press release or making the public disclosure.

 

18.13         Survival. The rights and obligations of the parties under Articles
11 (Confidential Information), 12 (Intellectual Property), 13 (Indemnification),
14 (Insurance) to the extent expressly stated therein, 16 (Limitations of
Liability), 17 (Notice), 18 (Miscellaneous), and Section 15.3 (Duties Upon
Termination), shall continue notwithstanding expiration or termination of this
Agreement.

 

18.15         Force Majeure. Except as to payments required under this
Agreement, neither party shall be liable in damages for, nor shall this
Agreement be terminable or cancelable (except as provided in this Section 18.15)
by reason of, any delay or default in such party’s performance hereunder, if
such default or delay is caused by events beyond such party’s reasonable control
including, but not limited to, acts of God, regulation or law or other action or
failure to act of any government or agency thereof, war or insurrection, civil
commotion, destruction of production facilities or materials by earthquake,
fire, flood or storm, labor disturbances, epidemic, or failure of suppliers,
public utilities or common carriers; provided however, that the party seeking
relief hereunder shall promptly notify the other party of such cause(s). A party
that invokes this section shall use all commercially reasonable endeavors to
reinstate its ongoing obligations to the other; provided that if the cause(s)
shall continue unabated for one hundred eighty (180) days, then the party that
has not invoked this Section to excuse its delay or nonperformance may terminate
this Agreement, subject to the duties set forth in Section 15.3.

 

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separately with the Securities and Exchange Commission pursuant to a request for
confidential treatment.

 

18.16       No Strict Construction. The language used in this Agreement will be
deemed to be the language chosen by the parties to express their mutual intent,
and no rules of strict construction will be applied against any party.

 

IN WITNESS WHEREOF, the parties have caused their duly authorized representative
to execute this Agreement effective as of the date first written above.

 

OsoBio   Navidea       OSO BioPharmaceuticals Manufacturing, LLC   Navidea
Biopharmaceuticals, Inc.       By: /s/ Milton Boyer   By: /s/ Brent L. Larson
Name: Milton Boyer   Name: Brent L. Larson Its: President   Its: EVP & CFO

 

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confidential treatment.

 

EXHIBIT A

SPECIFICATIONS

 

SPECIFICATION FOR LYMPHOSEEK VIAL, 250mcg

 

Characteristic   Specification (Limits)   Test Method [*]   [*]   [*] [*]   [*]
  [*] [*]   [*]   [*] [*]   [*]   [*] [*]   [*]   [*] [*]   [*]   [*] [*]   [*]
  [*] [*]   [*]   [*] [*]   [*]   [*] [*]   [*]   [*] [*]   [*]   [*] [*]   [*]
  [*] [*]   [*]   [*]           [*]   [*]   [*] [*]   [*]   [*] [*]   [*]   [*]
[*]   [*]   [*] [*]   [*]   [*]

 

a [*]

b [*]

c [*]

d [*]

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Confidential Treatment – Asterisked material has been omitted and filed
separately with the Securities and Exchange Commission pursuant to a request for
confidential treatment.

 

EXHIBIT B

UNIT PRICING, FEES

 

UNIT PRICING Product   Dosage Form   Initial Unit Price Lymphoseek Vial, 250mcg
  Lyophilized, multi-dose vial   [*]1          

 

1 Unit pricing is based upon a [*] unit Batch size

 

ADDITIONAL FEES      

Annual Product Maintenance Fee

Includes:

·

·    Annual Product Reviews

·    Copies of Documents (Routine – Batch record related or Product specific)

·    Notification of Updates to Drug Master File (DMF)

·    Product Licenses

·    Navidea Complaints

Does not Include:

·    Rest of World (ROW) filings or additional countries after 1st filing

·    CMC Services after 1st filing

·    All additional countries Additional Annual, CBE or Prior Approval filings
with respect to changes to facilities and equipment initiated or required by
Navidea

• Labeling Changes requested by Navidea

[*] per year

Payable upon the Effective Date and once annually, on the anniversary date of
this Agreement and continuing following termination of this Agreement until all
Product Processed under this Agreement has expired.

 

 

Items excluded will be billed @ [*] to [*] per hour plus any actual external or
material resources and mutually agreed and approved in writing by both parties.

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Confidential Treatment – Asterisked material has been omitted and filed
separately with the Securities and Exchange Commission pursuant to a request for
confidential treatment.

 

EXHIBIT C

FORM OF QUALITY AGREEMENT

 

(To be appended upon execution of QAA for execution copies of Supply Agreement)

 

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Confidential Treatment – Asterisked material has been omitted and filed
separately with the Securities and Exchange Commission pursuant to a request for
confidential treatment.

 

EXHIBIT D

 

STATEMENT OF COMPLIANCE FOR MINIMUM QUANITIES OF LYMPLHOSEEK SOURCED BY NAVIDEA
BIOPHARMACEUTICALS, INC.

 

The quantities purchased in calendar year 20__ represent a minimum of [*] of the
annual requirements of Product purchased by Navidea from all sources.

 

Signed:

 

Name:

 

Title:

 

Date:

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