Document:

Exhibit 10.20

 

SERVICES AGREEMENT

(Specialty Pharmacy and Hub Services)

 

This
SERVICES AGREEMENT (“Agreement”), dated as of November 19, 2009 (the “Effective
Date”), is entered into by and between DYAX
CORP., a Delaware corporation with offices located at 300 Technology
Square, Cambridge, Massachusetts 02139 (“Dyax”), and US BIOSERVICES CORPORATION,
a Delaware corporation, on behalf of itself and its subsidiaries IHS
Acquisition XXX, Inc., Pharm Plus Acquisition, Inc., Ambulatory
Pharmacy Services, Inc. and Specialty Pharmacy, Inc., all of which do
business as US Bioservices, with its primary offices located at 3101 Gaylord
Parkway, Frisco, Texas 75034 (collectively, “US Bio”).

 

WHEREAS,
Dyax has developed the Product (as defined below);

 

WHEREAS,
in the United States, Dyax intends to secure the regulatory approvals required
in order to promote, market and sell the Product in the United States as a
treatment for patients suffering acute attacks associated with the disease
known as hereditary angioedema (“HAE”);

 

WHEREAS,
US Bio is in the business of providing specialty pharmacy and retail
distribution services for pharmaceutical products; and

 

WHEREAS,
Dyax wishes to engage US Bio to provide Dyax with specialty pharmacy and retail
distribution services for the Product throughout the United States, and US Bio
wishes to accept such engagement, all upon the terms and subject to the
conditions set forth in this Agreement.

 

NOW,
THEREFORE, for good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged,
the parties agree as follows:

 

1.             Definitions.

 

As used in this
Agreement, the following capitalized terms shall have the following meanings:

 

1.1                                 “Affiliate”
shall mean any individual, corporation, partnership, association, or business
that directly or indirectly through intermediaries, controls, is controlled by
or is under common control with, a party. An ownership, voting or similar
interest (including any right or option to obtain such an interest)
representing more than 50% of the total interests then outstanding of the
pertinent entity shall constitute “control” for the purposes of this
definition.

 

1.2                                 “Applicable
Laws” shall mean all applicable laws, rules, regulations in the Territory,
including guidelines and guidances promulgated by governmental entities.

 

1.3                                 “Competing
Product” shall mean any pharmaceutical product, other than the Product,
that is being developed, manufactured or commercialized for use as a
therapeutic or prophylactic treatment for Patients.

 

1.4                                 “FDA”
shall mean the United States Food and Drug Administration or any successor
agency thereto.

 

*Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

 

1.5                                 “Field”
shall mean all uses in the therapeutic treatment of HAE.

 

1.6                                 “HIPAA” shall
mean the Health Insurance Portability and Accountability Act of 1996, as
amended, 42 U.S.C. § 1320d, et seq., and the implementing regulations
promulgated thereunder.

 

1.7                                 “Hub Services”
shall have the meaning set forth in Section 8.1 below.

 

1.8                                 “Patient”
shall mean any person diagnosed with HAE.

 

1.9                                 “Product” shall mean Dyax’s proprietary plasma
kallikrein inhibitor, known as internally as DX-88 and generically as
ecallantide, as more formally described on Exhibit A.

 

1.10                           “REMS Program”
shall mean the Risk Evaluation and Mitigation Program required to be
implemented under Section 505-1 of the Federal Food, Drug and Cosmetic Act
in connection with the regulatory approval of the Product by the FDA.

 

1.11                           “SOPs”
shall have the meaning set forth in Section 8.4.

 

1.12                           “Specialty Pharmacy Customers” shall mean health-care
providers (generally physicians and physician-operated clinics) who receive
Product on behalf of specific Patients pursuant to a
physician-issued prescription in accordance with the terms and conditions set
forth in this Agreement.  For the
avoidance of doubt, Specialty Pharmacy Customer shall not include specialty
pharmacies, distributors, wholesalers or hospital, institutional or
other pharmacies.

 

1.13                           “Statement of Work” shall have the meaning set forth in Section 8.1.

 

1.14                           “Term”
shall have the meaning set forth in Section 15.1.

 

1.15                           “Territory”
shall mean the 50 states of the United States of America, the District of
Columbia and Puerto Rico.

 

2.                                      Engagement of US Bio.

 

2.1                                 Engagement.  Upon the terms and conditions set forth
herein, Dyax hereby engages US Bio, on an exclusive basis during the Term
(subject to Section 15.4), to (i) dispense and distribute Product to
Specialty Pharmacy Customers for the Field in the Territory, and (ii) provide
the Hub Services.  US Bio hereby accepts
such engagement and shall dispense and distribute Product to Specialty Pharmacy
Customers in the Territory and provide the Hub Services in a professional and responsible manner and in accordance with the terms of
this Agreement and all
Applicable Laws.

 

2.2                                 Authorized Distributor.  In connection with US Bio’s engagement under Section 2.1
above, and solely for the limited purpose of compliance with the pedigree
requirements of the Prescription Drug Marketing Act and any similar state laws,
Dyax hereby designates US Bio
as an Authorized Distributor of Record (“ADR”) of the Product during the Term.

 

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2.3                                 Exclusivity.

 

(a)                                  The parties
acknowledge and agree that as a result of the exclusive nature of the US Bio
engagement, (i) subject to Section 15.4, during the Term, Dyax shall
not engage any party other than US Bio or its Affiliates to dispense and
distribute Product to Specialty Pharmacy Customers for the Field in the
Territory or perform the Hub Services, (ii) during the Term and for [*****] thereafter, US Bio shall not,
and shall cause its Affiliates providing specialty pharmacy services not to,
provide services substantially similar to the Hub Services for any Competing
Product, and (iii) during the Term and for [*****] thereafter, US Bio shall not promote any Competing
Product.  To the extent that a
non-specialty pharmacy Affiliate of US Bio provides services for a Competing
Product, US Bio acknowledges that it will maintain the confidentiality and
security of all Dyax Confidential Information in accordance with Article 11
and that US Bio will not disclose any Confidential Information of Dyax, or any
acquired knowledge or learnings that US Bio may obtain in connection with the
performance of the Hub Services, to any such Affiliate.

 

(b)                                 The parties
acknowledge and agree that the restriction set forth in Section 2.3(a)(iii) shall
not preclude US Bio from (i) dispensing a Competing Product, (ii) providing
clinically appropriate information to healthcare providers, patients and others
in connection with dispensing a Competing Product, or (iii) providing
general information on US Bio’s specialty pharmacy services; provided that, in
each case US Bio does not violate the terms of this Agreement or otherwise
Disadvantage the Product in any way in the Territory.  For purpose of the foregoing sentence, “Disadvantage”
shall mean any activities that (X) are intended to encourage, or could
reasonably be foreseen to encourage, the utilization of a Competing Product, such as advertising the Product in a manner
that suggests that a Competitive Product is superior to the Product in terms of
acquisition price, reimbursement rates, or efficacy, or (Y) otherwise
operate to the disadvantage of the Product.

 

2.4                                 Reserved Rights.

 

(a)                                  Except as
expressly provided in this Agreement, no right, title or interest in or to
Product or any patent, trade secret, trademark or any other intellectual
property right of Dyax or its Affiliates is granted, whether express or
implied, by Dyax to US Bio.  In
furtherance of the foregoing and not in limitation thereof, nothing herein
shall in any way limit Dyax’s ability to (i) dispense or distribute
Product to Specialty Pharmacy Customers outside of the Territory, (ii) dispense
or distribute Product to Specialty Pharmacy Customers in the Territory for uses
outside the Field or (iii) dispense or distribute Product to any person or
entity other than a Specialty Pharmacy Customer, including specialty pharmacies, distributors, wholesalers or hospital
pharmacies or health-care providers that
purchase Product on a wholesale basis (e.g., buy-and-bill or consignment).

 

(b)                                 Except as
expressly provided in this Agreement, no right, title or interest in or to any
patent, trade secret, trademark or any other intellectual property right of US
Bio or its Affiliates is granted, whether express or implied, by US Bio to Dyax.  By way of clarification,
all proprietary systems, databases and web-based applications, and any 

 

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standard
operating procedures, work rules, programming, software, routines, analytic
tools, embedded logic or table structures associated therewith, that have been
developed, maintained, utilized and improved by US Bio (or its
Affiliates) in connection with this Agreement
or the Hub Services are and will remain the property of US Bio (or its
Affiliates).

 

2.5                                 Service Level
Commitments.  The parties
to this Agreement desire to define a mutually beneficial relationship between
Dyax and US Bio in order to achieve Dyax’s goals of high patient level product
availability, high levels of consumer and pharmacy confidence in the integrity
and quality of the Product, and achievement of a collaborative, transparent, and
cost-effective distribution system.  In
order to achieve the stated goals, US Bio agrees to dispense and distribute the
Product and perform the Hub Services hereunder in accordance with the key
performance indicators described in the Statement of Work attached hereto as Exhibit B and incorporated herein by this reference.

 

3.                                      Purchase and Sale of Product.

 

3.1                                 Purchase of Product.  US Bio shall (i) purchase Product only
from Dyax (or its third party logistics provider acting on Dyax’s behalf) and no other supplier, (ii) dispense and distribute Product that it has purchased from Dyax, and (iii) dispense and
distribute Product only to Specialty Pharmacy
Customers for the Field in the Territory. 
US Bio shall fill orders for Product only with Product and shall not
substitute other products.

 

3.2           Purchase Price; Payment Terms.

 

(a)                                  The price
payable by US Bio to Dyax for all Product purchased by US Bio hereunder (the “Purchase
Price”) shall be [*****].

 

(b)                                 Dyax promptly
shall invoice US Bio for the Purchase Price for all Product purchased
hereunder.  All Dyax invoices for Product
shall be due and payable by US Bio within [*****] after receipt by US Bio [*****].  On all
undisputed balances exceeding [*****]
from invoice receipt, US Bio shall pay interest equal to the lesser of (i) [*****] per month and (ii) the
maximum allowed by law.

 

4.                                      Delivery
of Product to US Bio.

 

4.1                                 Product Orders.  US Bio shall submit all Product orders
electronically in the industry standard format in accordance with such
procedures as may be mutually agreed upon by the parties.  Unless otherwise agreed between the parties,
all Product orders shall be submitted in quantities of 20 units (or multiples
of 20 units).

 

4.2                                 Delivery Times.  Dyax shall make commercially reasonable
efforts to ship all US Bio orders completely and to have Product from such
orders shipped to US Bio within a mutually agreeable schedule of up to [*****] of order placement.  US Bio acknowledges and agrees that Dyax may
not be able to fill all orders completely or within a specified time due to
shortages or other causes and such inability shall not constitute a breach of
this Agreement.

 

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4.3                                 Product Dating.  Dyax shall ship Product to US Bio with at
least [*****] shelf life
remaining, unless otherwise agreed in writing (including
via email or other electronic communication) by US Bio.  [*****]

 

4.4                                 Product Delivery; Risk of Loss.  Dyax
shall deliver all Product Free On Board to US Bio’s facility in the
Territory designated in the applicable order. 
For purposes of this Section, the term “Free On Board” means that Dyax
shall (i) bear all costs associated with shipping Product to the US Bio
designated facility, and (ii) bear all risk of loss for Product until its
delivery to the designated US Bio facility. 
Title to, and risk of loss of, all Product shall pass to US Bio on
delivery.

 

4.5                                 Inspection of Product.  US Bio shall
examine the Product upon delivery at US Bio’s designated facility and shall
notify Dyax in writing (including via
email or other electronic communication) within one (1) business
day of any problems relating to the quantity of Product delivered or any defect
in any of the Product that is reasonably discoverable upon visual inspection of
the Product without unpacking of pallets.

 

4.6                                 No Alteration. 
US Bio shall not alter the Product in any way,
including the packaging thereof, without Dyax’s written consent (except to
remove the Product from the shipping containers) and shall not alter the
Product labeling, except to add a prescription label to the Product upon
dispensing or shipment, as required by Applicable Laws.

 

4.7                                 Storage
Conditions.  US Bio will maintain Product stored at, and
shipped from, its facilities under (i) the Product storage, shipment and
handling requirements set forth in the FDA-approved labeling and  (ii) any additional requirements mutually agreed upon
between US Bio and Dyax.  US Bio shall notify Dyax within one (1) business
day of any deviation from such
requirements so that Dyax can determine whether any further action must be
taken with respect to such Product. 
Failure of US Bio to notify Dyax promptly of such deviation shall
constitute a breach of this Agreement by US Bio.

 

5.                                      Product Inventories.

 

5.1                                 Inventory Levels.  During the Term, unless otherwise agreed to
by Dyax in writing (including via
email or other electronic communication) and subject to Section 5.2,
US Bio shall maintain at all times an inventory of Product in an amount equal
to not less than [*****] nor
more than [*****] of [*****].

 

5.2                                 Supply Shortages.  US Bio shall have no obligation to maintain
the minimum inventory levels described in Section 5.1 if Product is
unavailable from Dyax.

 

6.                                      Product
Returns.

 

Dyax (or Dyax’s third party logistics provider acting
on Dyax’s behalf) shall accept and process returns of Product purchased by US
Bio hereunder in accordance with Dyax’s Product Returns Policy, as it may be
amended from time to time by Dyax.  A
copy of the Product Returns Policy in effect as of the Effective Date is
attached to this Agreement as Exhibit D.

 

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7.                                      Suspension, Recalls and Government Notices.

 

7.1                                 Suspension.  Upon written notification by Dyax to suspend
distribution of Product, US Bio immediately shall suspend its distribution of
Product.  If the suspension continues for
more than [*****], Dyax will
repurchase Product in saleable condition held in inventory by US Bio at the
price paid for such Product by US Bio. 
All repurchased Product shall be returned to Dyax (or Dyax’s third party
logistics provider) at Dyax’s expense.

 

7.2                                 Recalls.

 

(a)                                  Recalls
Procedures.  Dyax shall
promptly notify US Bio of any recalls or market withdrawals initiated by Dyax
or required by the FDA or any other governmental agency.  US Bio shall notify Dyax immediately of any
event or circumstance that US Bio reasonably believes may necessitate a recall
or market withdrawal.  Upon receipt of
notice of a recall or market withdrawal from Dyax, US Bio shall administer such
recall or market withdrawal under the direction of Dyax, including promptly
notifying the affected Specialty Pharmacy Customers of US Bio in accordance
with Dyax’s instructions.  Dyax shall
provide US Bio with a form letter to be used in connection with notice of any
recall or market withdrawal, and shall, to the extent practicable, provide US
Bio the opportunity to review and comment on such letter.  Dyax shall be responsible for the mailing,
shipping, and reasonable administrative expenses incurred by US Bio in connection
with the recall or market withdrawal, plus a reasonable service fee as mutually
agreed upon in advance by the parties as well as the cost of replacement
Product for US Bio’s Specialty Pharmacy Customers.  Notwithstanding the foregoing, to the extent
that such recall or market withdrawal arises or results from (i) the
negligence or intentional misconduct of US Bio or any of its permitted agents
or employees or (ii) the breach by US Bio of this Agreement, US Bio shall
bear and be responsible for all such costs as well as the reasonable,
documented, out-of-pocket expenses of Dyax incurred in connection with such
recall or market withdrawal.

 

(b)                                 Investigations;
Cooperation.  US Bio shall
reasonably cooperate with Dyax in investigating any Product failure that
resulted in the need for a recall or market withdrawal and any reasonable,
documented, out-of-pocket cost involved with such investigation shall be
reimbursed by Dyax, except to the extent that such recall or market withdrawal
arises or results from (i) the negligence or intentional misconduct of US
Bio or any of its permitted agents or employees or (ii) the breach by US
Bio of this Agreement, in which event US Bio shall bear and be responsible for
such costs as well as the reasonable, documented, out-of-pocket expenses of
Dyax incurred in connection with such investigation.

 

7.3                                 Government
Notices.  Each party shall provide the
other with a copy of any correspondence or notices it receives from the FDA, or
other governmental entity specifically relating to activities conducted under
this Agreement, no later than one (1) business day following such
receipt.  In addition, US Bio shall
provide Dyax with any notice it receives from the FDA or other governmental
entity relating to Product no later than one (1) business day following
such receipt.  Each party shall also
provide the other with concurrent copies of any responses to any such
correspondence or notices (e.g., a response to an FDA 483 notice, warning
letter, or untitled regulatory letter); 

 

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provided that Dyax shall review and approve all such
responses by US Bio to the extent related to the Product and to the extent
reasonably feasible.  Where reasonably
possible, US Bio shall give prior notice to Dyax of any scheduled FDA or other
governmental inspection of US Bio’s facilities specifically relating to the
Product, and, if reasonably possible, will afford Dyax the opportunity to be
present at such inspection.

 

8.                                      Hub Services and Related US Bio Obligations.

 

8.1                                 Hub Services;
Statement of Work.   US Bio
shall provide certain support services relating to (i) the sale and use of
the Product in the Field in the Territory and (ii) the REMS Program
(collectively, the “Hub Services”).  The
specific nature of such Hub Services, and any additional terms and conditions
applicable to such Hub Services, shall be set forth in writing (each such
writing, a “Statement of Work”).  The
initial Statement of Work that has been agreed upon by the parties is attached hereto
as Exhibit B.  Any changes to the initial Statement of Work
or any new Statement of Work must be in writing and approved by both parties,
and thereafter shall be considered an addendum to this Agreement.  All Services performed under any Statement of
Work shall be subject to all the terms and conditions set forth herein.

 

8.2                                 REMS Program.  US Bio shall distribute
Product, perform the Hub Services, and otherwise conduct all activities under
this Agreement in accordance with the REMS Program and any additional policies
Dyax implements and provides in writing to US Bio.  Without limiting the scope of the foregoing,
US Bio agrees that any promotional, educational or other materials delivered to
Specialty Pharmacy Customers and/or Patients
in connection with this Agreement shall be preceded or accompanied by the
medication guide, the healthcare provider letter and/or any other materials
required by the REMS Program, as applicable, and in accordance with the
provisions of the REMS Program.

 

8.3                                 Adverse Event
Reporting.  In the event that an adverse
experience, as that term is defined at 21 C.F.R. § 600.80 (as such provision
may be amended from time to time), with regard to the Product is reported to US
Bio, US Bio shall ensure that all applicable safety and other relevant
information relating to the Product that is obtained during the course of any
interaction with patients, healthcare providers, or other individual, is
communicated and maintained in accordance with Applicable Laws.  US Bio shall notify Dyax of any adverse drug
experiences with regard to the Product within three (3) business days
after its first receipt; provided however, that any information relating to a
serious adverse experience (SAE), as that term is defined at 21 C.F.R. § 600.80
(as such provision may be amended from time to time), shall be provided to Dyax
within one (1) business day after its first receipt.  US Bio shall also make all reasonable efforts
to assist Dyax with any follow-up investigation necessary to comply with
Applicable Laws with respect the reporting of adverse drug experiences relating
to the Product; provided, that US Bio will not be responsible for reporting of
any adverse events to the FDA.  Dyax and
US Bio will ensure that appropriate SOPs (as defined in Section 8.4)
regarding adverse experiences are established, maintained and regularly
reviewed to ensure compliance in accordance with the terms of this Agreement
and Applicable Laws.  Dyax and US Bio will ensure that all staff
involved in these activities are appropriately trained and records of such
training are maintained.

 

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8.4                                 Standard
Operating Procedures; Other Work Instructions.  US Bio shall conduct all Hub Services under
this Agreement in accordance with Standard Operating Procedures (“SOPs”) and
other Dyax-specific work instructions (“Dyax Instructions”) applicable to such
activities, as established and approved in writing by the parties from time to
time.  The preliminary SOPs and Dyax
Instructions that have been approved by the parties are attached hereto as Exhibit C.  [*****]  The parties acknowledge and agree that the
Hub Services SOPs and Dyax Instructions are the property of Dyax and to the
extent that such Hub Services SOPs and Dyax Instructions are maintained by US
Bio, then, upon termination or expiration of this Agreement or otherwise upon
Dyax’s request, US Bio will deliver such SOPs and Dyax Instructions to
Dyax.  Notwithstanding anything to the
contrary contained in this Agreement or elsewhere, during the Term of this
Agreement, the SOPs shall not include any of US Bio’s internal standard
operating procedures or work instructions that are non-specific to Dyax and the
Product, which are the confidential and proprietary property of US Bio and
shall not be disclosed by Dyax to any third party without the consent of US
Bio.  Dyax shall be permitted, upon its
reasonable request, to review any of US Bio’s internal standard operating
procedures or work instructions at US Bio’s facility.  Upon termination of this Agreement, any of US
Bio’s internal standard operating procedures or work instructions in Dyax’s
possession will be returned to US Bio or (at US Bio’s election) destroyed by
Dyax, with Dyax providing US Bio with a written certification of destruction.

 

8.5                                 No
Subcontracting or Subdistribution.  All obligations and services to be performed
by US Bio under this Agreement shall be solely performed by US Bio and US Bio
shall not outsource or subcontract any of its obligations hereunder without
Dyax’s prior written consent.

 

8.6                                 Applicable Laws and Regulations.  US Bio shall conduct all
activities under this Agreement in compliance with
all Applicable Laws, including federal and state pharmacy or pedigree
laws, laws relating to the promotion of prescription medicines including the
prohibition of off-label promotion, federal and state laws protecting the
privacy of patient or prescriber identifiable information (including HIPAA),
federal and state anti-kickback laws and regulations, laws relating to the disposal
of pharmaceutical products and hazardous wastes, and all applicable
professional and industry standards and good business practices.  If Dyax reasonably
determines that US Bio has conducted activities under this
Agreement in a manner that could potentially
compromise public health or safety, then Dyax may terminate this Agreement
immediately, and whether or not Dyax terminates this Agreement, may pursue all
other legal remedies available to it.

 

8.7                                 Product Promotion.  US Bio will not
provide any information regarding the safety, effectiveness, or use of Product
to Specialty Pharmacy Customers or other persons or entities except as approved
in advance in writing by Dyax or required by Applicable Laws.  US Bio may provide information on its own
specialty pharmacy and distribution services to its Specialty Pharmacy
Customers in accordance with US Bio standard business practices, including
informing its Specialty Pharmacy Customers of pricing available for the Product
and other products distributed by US Bio. 
US Bio warrants that any information it provides to its Specialty
Pharmacy Customers regarding Product or its services will be truthful and
non-misleading and will comply with all Applicable Laws.

 

8.8                                 Discounts.  To the extent required by Applicable Laws, including 42 U.S.C. §§ 1320a-7b(b) and
in conformance with the standards set forth in 42 C.F.R. § 1001.952(h) for
safe harbor protection, US Bio shall advise and inform each of its Specialty
Pharmacy Customers to fully report, as required by 

 

8

 

law or contract, any
discounts, rebates, or reductions in prices on Product and provide the discount
information supplied by US Bio to the Department of Health and Human Services
or a state agency upon request, consistent with the requirements of 42 U.S.C. §
1320a-7b(b) and 42 C.F.R. § 1001.952(h).

 

8.9                                 Diversion.  US Bio shall notify Dyax in writing
(including via email or other electronic communication) promptly within one (1) business
day of learning of information to
suggest that any person or entity is diverting or attempting to divert
Product.  For the purposes of this Section 8.9,
“diverting” means the unauthorized sale, distribution, purchase, receipt,
or handling of Product.  Dyax may immediately terminate this Agreement upon written notice
if it is determined by Dyax that US Bio has purchased Product from sources
other than Dyax or its designated third party logistics provider.

 

9.                                      Compensation
for Hub Services.

 

Dyax
will compensate US Bio for the Hub Services in accordance with the Statement of
Work.  For clarity, the fees on Statement
of Work shall be and remain in effect for the duration of the Term, provided
that if Dyax terminates its agreement with either of US Bio’s Affiliates,
Integrated Commercialization Solutions, Inc. or ASD Specialty Healthcare, Inc.,
such fees may be subject to adjustment. 
Within [*****] following the
end of each calendar month during the term of this Agreement, US Bio shall
provide a detailed invoice that specifically identifies the Hub Services
conducted by US Bio during that calendar month. 
Dyax shall notify US Bio of any disputed charges in writing within [*****] following receipt of the invoice covering such
charges.  In the absence of any such
notice of dispute, all invoices shall be deemed to be correct and due in full
within [*****] following receipt of the
invoice.  On all undisputed invoice
balances exceeding [*****], Dyax shall pay
interest equal to the lesser of (i) [*****] per month and (ii) the
maximum allowed by law.

 

10.                               Reports and Records.

 

10.1                           Product Reports.  US Bio shall generate and
furnish to Dyax (or its designee) the Product reports specified in the
Statement of Work attached as Exhibit B (collectively,
the “Product Reports”).

 

10.2                           Activity Reports.  In addition to any specific reports that US
Bio may be required to deliver to Dyax under this Agreement, US Bio shall
provide to Dyax (or its designee) all
information and reports related to its activities with respect to the Product
that are reasonably requested by Dyax and can be prepared by US Bio without
undue burden; provided, that US Bio shall be compensated and fully reimbursed
by Dyax for any additional time and expense incurred in connection with the
preparation and delivery of such information and/or reports.

 

10.3                           Compliance.  The parties intend that all reports provided
to Dyax under Sections 10.1, 10.2 and 13.3 shall comply with Applicable Laws,
including HIPAA and any laws relating to the identity of the Patient or
prescriber.  Accordingly, the parties
agree that US Bio shall only provide Dyax with patient information that is
de-identified in accordance with HIPAA’s de-identification provision, 45 C.F.R.
§ 164.514(b), unless: (i) Dyax or US Bio has on file a valid,
HIPAA-compliant written authorization for each patient whose protected health
information (“PHI”) is sought to be disclosed; or (ii) written
authorization is not required under Applicable Laws in order to disclose the
PHI sought.  To the extent they may be
required by HIPAA, US Bio shall obtain any Business 

 

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Associate Agreements (as described in 45 C.F.R. §
164.504) that are necessary to fulfill its obligations under this
Agreement.  In the event of any
inconsistency between the data file layouts described for the Product Reports
in the Statement of Work attached as Exhibit B
and this Section 10.3, the terms of this Section 10.3 shall
control.  In the event of any amendment
to any Applicable Laws, US Bio shall be entitled to unilaterally modify the
data reports, without consent from Dyax, as required to comply with such
amendments; provided that US Bio shall provide Dyax with notice of such
modification and a description of the amendment requiring such modification
prior to submitting a modified data report. 
In addition to the foregoing, the parties acknowledge that existing
contractual relationships with third party payors may restrict US Bio’s ability
to collect, use, and/or disclose certain Patient-, payor-, or
physician-specific data.

 

10.4                           Ownership and
Use of Data.  Subject to
Applicable Laws, Dyax shall have the following rights with respect to
information and data relating to Product, the sale of Product to Specialty
Pharmacy Customers and the use by Product of Patients obtained, maintained,
generated or furnished by US Bio to Dyax in connection with performing US Bio’s
obligations hereunder, including such data and information contained in the
reports delivered pursuant to Sections 10.1 and 10.2:

 

(a)                                  With respect to
the activity and other data generated in connection with the Hub Services
(which shall be captured in the Hub Services database and may be reported to
Dyax pursuant to this Agreement), Dyax shall own and have the exclusive right
to use all such information and data (provided, that US Bio may use any and all
information and data to the extent required in its performance of the Hub
Services or as otherwise necessary in connection with its dispensing of Product
and related services to Patients) and all such information shall be deemed to
be Dyax Confidential Information; and

 

(b)                                 The parties
acknowledge and agree that US Bio shall own product dispensing data and any
other clinical data related to such dispensing activities.  With respect to all information and data not
covered by Section 10.4(a) but which is provided by US Bio to Dyax in
accordance with this Agreement, Dyax shall have a right to use any and all
information and data, for any purpose
as permitted by law or, to the extent such data contain PHI, as permitted by the
applicable patient’s written authorization or as otherwise allowed under the
law.

 

10.5                           Records.  US Bio shall keep complete and accurate books
and records pertaining to US Bio’s activities under this Agreement.  Such books and records shall be retained for
at least [*****] after the expiration or termination of this Agreement or for
such longer period as may be required by Applicable Laws.

 

10.6                           Audits.  Dyax, at its expense, from time to time may
perform, or have an independent third party auditor (subject to execution of a
mutually agreeable nondisclosure agreement) perform, audits of the records
maintained pursuant to Section 10.5 and may observe, or have an
independent third party auditor observe, the performance by US Bio of its
activities hereunder to verify the status of Product and ensure compliance with
the terms of this Agreement.  Dyax shall
provide US Bio with at least ten (10) business days advance written notice
of such audits or observations, and shall conduct any audit or observation
during normal business hours in a manner that does not interfere with US Bio’s
normal business operations.  US Bio shall
make available relevant records that do not 

 

10

 

contain
information pertaining to US Bio’s other clients or products and permit such
observations.  Dyax and US Bio shall
discuss the results of any such audits or observations and US Bio shall
implement all corrective measures reasonably requested by Dyax.  All audits shall be reasonable in time and
scope.

 

11.                               Confidentiality.

 

11.1                           Confidential
Information.  All
confidential, non-public documents and other information disclosed to a party
by or on behalf of the other party pursuant to this Agreement, which includes
but is not limited to information concerns prices and quantities purchased by
any customer, Product information, pricing, fees and proposals, operating and
sales data, information about processes, systems, strategic plans, business
plans, financial information, processes (including SOPs), customer information,
information concerning patients or physicians, methods, databases, technology
(including software and all source code), and any analysis, compilation, or
study, and any other information or materials prepared or derived from such information
(collectively, “Confidential Information”), shall, subject to Sections 11.2 and
11.3, be held by the receiving party in strict confidence and not
disclosed either directly or indirectly to any third party (other than
Affiliates, advisors and consultants who have a need to know such information
and who are subject to obligations of confidentiality at least as onerous as
those set forth herein) and shall only be used for purposes of fulfilling the
receiving party’s obligations, or exercising its rights, under this
Agreement.   Notwithstanding the
foregoing, all data and information owned by Dyax pursuant to Section 10.4
shall be the Confidential Information of Dyax and not US Bio, and regardless of
the party that discloses such Confidential Information hereunder, Dyax shall be
deemed the disclosing party, and US Bio shall be deemed the receiving party,
with respect to such Confidential Information. 
The terms and conditions of this Agreement and any amendments or addenda
thereto shall be deemed the Confidential Information of each party.

 

11.2                           Exclusions from
Confidentiality. 
Notwithstanding anything to the contrary in this Agreement, the
receiving party shall have no liability to the disclosing party for the use or
disclosure of any Confidential Information that the receiving party can
establish by written documentation to:

 

(a)                                  have been
publicly known prior to disclosure by the disclosing party of such information
to the receiving party;

 

(b)                                 have become
publicly known without fault on the part of the receiving party, subsequent to
disclosure to the receiving party;

 

(c)                                  have been
received by the receiving party at any time from a source, other than the
disclosing party, lawfully having possession of and the right to disclose such
information;

 

(d)                                 have been
otherwise known by the receiving party prior to disclosure by the disclosing
party to the receiving party of such information; or

 

(e)                                  have been
independently developed by the receiving party without use of information
disclosed by the Disclosing Party.

 

11

 

11.3                           Required
Disclosure.  A party
receiving Confidential Information may disclose such Confidential Information
if required to do so by a court (or other governmental agency or stock exchange
of competent jurisdiction), any governmental body or as required under any
Applicable Laws; provided that (i) the party required to disclose such
Confidential Information provides prompt notice of such pending disclosure to
the disclosing party so that the disclosing party can seek a protective order
or to prevent such disclosure, and (ii) the party required to disclose
such Confidential Information shall exercise reasonable efforts to ensure that
the information is accorded confidential treatment by the court or other
governmental agency or stock exchange.

 

11.4                           Survival of
Confidentiality Obligations.  The provisions of this Section 11 shall
survive for a period of [*****] following the
expiration or termination of this Agreement.

 

11.5                           Injunctive Relief.  Each party acknowledges that
the failure by the Receiving Party to comply with any of the provisions of this
Section 11 will result in irreparable injury and continuing damage to the
disclosing party for which there will be no adequate remedy at law and that, in
the event of a failure of the receiving party so to comply, the disclosing
party shall be entitled to seek such preliminary and permanent injunctive
relief as may be necessary to ensure compliance with all the provisions of this
Section without having to prove actual damages or to post a bond.

 

12.                               Use of Marks.

 

For the purposes of this Agreement, Dyax hereby grants to US Bio a non-exclusive,
non-transferable, revocable license to use Dyax’s trademarks,
trade names and service marks used and/or owned by Dyax with respect to
the Product (collectively, the “Marks”). 
The Marks shall be used by US Bio solely in connection with its sale,
distribution and/or delivery of Product, and other activities conducted under
this Agreement, in each case solely in accordance with the terms hereof.  The ownership of and goodwill in all Marks
shall remain the sole and exclusive property of Dyax and inure
exclusively to Dyax’s sole benefit,
both during the Term and thereafter.  US
Bio agrees that nothing in this Agreement shall give US Bio any right, title or
interest in or to the Marks other than the right to use the same in the manner
contemplated by this Agreement and only for so long as this Agreement is in
force.

 

13.                               Additional
Representations, Warranties and Covenants.

 

13.1                           Authorization.  Each party represents and warrants to the
other party that it has the legal right and power to enter into this Agreement,
to extend the rights and licenses granted to the other in this Agreement, and
to fully perform its obligations hereunder, and that the performance of such
obligations will not conflict with its charter documents or any agreements,
contracts, or other arrangements to which it is a party.  Furthermore, no approvals, consents, orders
or authorizations of or designation, registration, declaration or filing with
any governmental authority (within the Field in the Territory) is required for
either party’s performance of its obligations under this Agreement, other than
any approvals that have been obtained already or will be obtained in the
ordinary course of the performance of such obligations.

 

13.2                           No Other Agreements.  Each
party represents and warrants to the other that this Agreement is not
dependent on, and does not operate in conjunction with (either explicitly or
implicitly), any other arrangement between Dyax and US Bio.

 

12

 

13.3                           Product Pricing.  US Bio represents, warrants
and covenants that:

 

(a)                                  it will refrain
from doing anything that would impede Dyax from meeting any reporting
obligations with respect to Product pricing that Dyax may have under Applicable
Laws;

 

(b)                                 it will report
the Product sales price offered to Specialty Pharmacy Customers on the invoices
or statements submitted by US Bio to Dyax; and

 

(c)                                  no discount
provided or other payment made pursuant to this Agreement is intended in any
way as a discount related to a drug formulary and has not been negotiated or
discussed between the parties in connection with any drug formulary.

 

To the extent required under Applicable Laws, US Bio
will report the discounts to appropriate Federal health care programs, and in
any event, will promptly disclose such discounts if requested by a government
agency.

 

13.4                           Hub Services;
Service Fees.  The parties mutually represent
and warrant to each other that:

 

(a)                                  the service fees
paid to US Bio in connection with the Hub Services (i) are not intended in
any way as remuneration for US Bio to use, purchase, or recommend any Dyax
product or service, except as provided for in this Agreement,  (ii) represent the fair market value for
the Hub Services based upon arms length negotiations, (iii) are bona fide service fees that do not constitute a discount or
other form of compensation that must be included in Dyax’s reporting of pricing
information for Product to the Centers for Medicare and Medicaid Services;

 

(b)                                 the service fees
paid to US Bio in connection with the Hub Services are not intended in any way
as payment related to a drug formulary or drug formulary activities and have
not been negotiated or discussed between the parties in connection with any
such drug formulary or formulary activities; and

 

(c)                                  the Hub Services
do not involve the counseling or promotion of a business arrangement or other
activity that violates any state or federal law.

 

13.5                           Federal Programs.  US Bio
represents, warrants and covenants to Dyax that (a) neither
US Bio nor any of its Affiliates that perform activities under this Agreement
has been debarred or is subject to debarment pursuant to Section 306 of
the Act or listed on either Excluded List (as defined herein), and (b) neither
US Bio nor any of its Affiliates that perform activities under this Agreement
will  knowingly (after reasonable
investigation) use in any capacity, in connection with the services to be
performed under this Agreement, any person who has been debarred pursuant to Section 306
of the Act, or who is the subject of a conviction described in such section, or
listed on either Excluded List.  US Bio
shall inform Dyax in writing immediately if it or any person who is performing
services hereunder is debarred or is the subject of a conviction described in Section 306
of the Act or listed on either Excluded List, or if any action, suit, claim,
investigation or legal or administrative proceeding is pending or, to the best
of US Bio’s knowledge, is threatened, relating 

 

13

 

to the debarment or
conviction Section 306 of the Act, or listing on either Excluded List, of
US Bio or any person performing services hereunder.  “Excluded Lists” means the Department of
Health and Human Service’s List of Excluded Individuals/Entities and the
General Services Administration’s Lists of Parties Excluded from Federal
Procurement and Non-Procurement Programs.

 

13.6                           Licensure.  US Bio represents and warrants that it now
has and shall maintain in full force during the Term all applicable federal and
state pharmacy and other licenses or approvals required under Applicable Laws
and regulations to fulfill its obligations under this Agreement in each state
in the Territory, the District of Columbia and Puerto Rico.  US Bio promptly shall notify Dyax of any
denials, revocations or suspension of license or registrations by any state or
federal agency or any other regulatory authority in the Territory, or any
written notice from a governmental body proposing such a denial, revocation or
suspension of a license or registration. 
US Bio shall promptly provide Dyax with notice of any material
communications with pharmacy licensing boards which relate to potential
problems with facilities, operations, contractors or procedures used by US Bio
in distribution of the Product, including notices of inquiries, investigations
or inspections and resulting findings, except that  in no event shall US Bio be required to
disclose information concerning its other clients or the products of such
clients.

 

13.7                           Dyax
Representations and Warranties.  Dyax hereby represents and warrants to US Bio
that, at the time of delivery of Product by Dyax to US Bio hereunder: (a) such
Product shall not in any material respect be adulterated, misbranded or
otherwise prohibited within the meaning of the Federal Food, Drug and Cosmetic
Act, 21 U.S.C. §§ 301 et. seq., as amended and in effect at the time of
delivery (the “Act”), or within the meaning of any applicable state or local
law; (b) such Product will be merchandise that may be introduced and
delivered into interstate commerce under the provisions of Section 301 of
the Act or Section 351 of the Public Health Service Act; (c) Dyax (or
as applicable its designated third-party logistics provider) has and will
maintain, in full force and effect, all licenses and permits required under
Applicable Laws for Dyax to sell and distribute such Product under this
Agreement; (d) such Product will be the subject of a duly approved Biologics License Application and may
be legally transported or sold under Applicable Laws; (e) such Product
will have been approved by each applicable governmental authority for
commercial sale and shipment of such Product within the Territory; and (f) Dyax
either (i) owns or holds the duly
approved Biologics License Application, as such term is used in the Public
Health Service Act, Title 21, United States Code, as amended for such Product,
or (ii) is otherwise considered the “manufacturer” of such Product within
the meaning of any applicable federal, state or local law relating to pedigrees.

 

13.8                           No Other
Warranties.  Except as
expressly provided herein, neither party hereto makes any representations or
warranties to the other party, express or implied, either in fact or by
operation of law, by statute or otherwise, and each party specifically
disclaims any express or implied representations and warranties of
merchantability or fitness for a particular purpose.

 

14

 

14.                               Liability,
Indemnification and Insurance.

 

14.1                           Remedies.

 

(a)                                  Generally.  Rights and remedies under this Agreement are
cumulative and in addition to any other available rights or remedies under any
other agreement, at law or in equity.

 

(b)                                 Equitable Relief.  If either party violates or threatens to
violate any provision of this Agreement, the other party may suffer irreparable
harm and its remedies at law may be inadequate. 
Accordingly, the other party may seek equitable relief.

 

14.2                           Indemnification.

 

(a)                                  Indemnification
by US Bio.  US Bio shall
indemnify, defend, and hold harmless Dyax and its Affiliates and its and their
respective directors, officers, employees, representatives and agents and their
respective successors, heirs and assigns (the “Dyax Indemnitees”) against any
liability, damage, loss, penalty, fine or expense (including reasonable
attorneys fees and expenses of litigation) (collectively, “Losses”) incurred by
or imposed upon the Dyax Indemnitees or any of them in connection with any
claims, suits, demands, investigations, enforcement actions, or judgments, in
each case initiated by a third party (including any governmental or regulatory
agency) (collectively, “Third Party Claims”) which arise out of: (a) the gross
negligence or willful misconduct of US Bio in connection with this Agreement;
or (b) the breach of this Agreement by US Bio, in each case except for
those Losses for which Dyax has an obligation to indemnify US Bio pursuant to Section 14.2(b),
as to which Losses each party shall indemnify the other to the extent of its
respective liability for such Losses.

 

(b)                                 Indemnification
by Dyax.  Dyax shall indemnify, defend,
and hold harmless US Bio and its Affiliates and its and their respective
directors, officers, employees, representatives and agents and their respective
successors, heirs and assigns (the “US Bio Indemnitees”) against any Losses
incurred by or imposed upon US Bio Indemnitees or any of them in connection
with any Third Party Claims which arise out of: (a) the negligence or
willful misconduct of Dyax in connection with this Agreement; (b) the
breach of this Agreement by Dyax, in each case except for those Losses for
which US Bio has an obligation to indemnify Dyax pursuant to Section 14.2(a);
(c) any claims of patent, trademark, copyright or other infringement
related to Products; or (d) the storage, handling, use, non-use,
demonstration, consumption, ingestion, digestion, manufacture, production and
assembly of Products and their transportation to US Bio (except to the extent
that such activities are conducted on Dyax’s behalf by an Affiliate of US Bio),
as to which Losses each party shall indemnify the other to the extent of its
respective liability for such Losses.

 

(c)                                  Indemnification
Procedure.  A party that
intends to claim indemnification under this Section 14.2 (the “Indemnitee”)
shall:  (i) promptly notify the
indemnifying party (the “Indemnitor”) in writing of any Third Party Claim in
respect of which the Indemnitee or any of its Affiliates or any of their
respective directors, officers, employees, representatives, agents or their
respective successors, heirs or assigns intend to claim such indemnification
hereunder; (ii) provide the Indemnitor sole control of the defense and/or
settlement thereof with counsel reasonably satisfactory to the Indemnitee; provided, however, that the Indemnitee reserves the right to retain its
own counsel to defend itself in, but not control the defense of, such suit, at
its own expense, unless (a) 

 

15

 

the
interests of the Indemnitee and the Indemnitor in the suit conflict in such a
manner and to such extent as to require, consistent with applicable standards
of professional responsibility, the retention of separate counsel for the
Indemnitee, in which case, the Indemnitor shall pay for one separate counsel
chosen by the Indemnitee or (b) the Indemnitor shall not have employed
attorneys reasonably satisfactory to the Indemnitee to defend any action within
a reasonable time after notice of commencement of such action and (iii) provide
the Indemnitor, at the Indemnitor’s request and expense, with reasonable
assistance and full information with respect thereto.  Neither
the Indemnitor nor the Indemnitee shall be responsible to or bound by any
settlement made by the other without its prior written consent, which shall not
be unreasonably withheld or delayed.  Without limiting the foregoing provisions of
this Section 14.2(c), the Indemnitor shall keep the Indemnitee reasonably
informed of the progress of any claim, suit or action under this Section 14.2
and the Indemnitee shall have the right to participate in any such claim, suit
or proceeding with counsel of its choosing at its own expense, but the
Indemnitor shall have the sole right to control the defense or settlement
thereof in accordance with the terms of this Section 14.2(c).

 

14.3                           Limitation of
Liability.

 

(a)                                  Neither party
shall be liable to the other for special, exemplary, consequential, incidental
(including lost or anticipated revenues or profits), indirect or punitive
damages arising from the performance or nonperformance of such party under this
Agreement whether such claim is based on contract, tort (including negligence)
or otherwise, even if an authorized representative of such party is advised of
the possibility or likelihood of same.

 

(b)                                 Notwithstanding
the exclusions and limitations of liability set forth in Section 14.3(a) above,
such exclusions and limitations shall not apply to: (i) either party’s indemnification
obligations pursuant to Section 14.2; or (ii) either party’s breach
of the party’s confidentiality obligations pursuant to Article 11.

 

14.4                           US Bio Insurance
Obligations.  During the
Term, US Bio shall maintain the following minimum levels of insurance:

 

(a)                                  Employer’s
liability insurance with a limit of [*****]  for bodily
injury by accident per person, [*****] for bodily
injury by accident, all persons and [*****] bodily injury
by disease policy limit;

 

(b)                                 Commercial
general liability insurance, including personal injury blanket contractual
liability and broad form property damage, with a [*****] combined single
limit;

 

(c)                                  Umbrella
liability insurance in the amount of [*****] per occurrence
and aggregate; and

 

(d)                                 Property
insurance covering the business property of US Bio and others while at any
unnamed location in the amount of [*****].

 

16

 

The insurance required by this Section 14.4 may
be made up through a combination of self-insured retention and traditional
insurance.  Throughout the Term, US Bio
shall (a) provide prompt written notice to Dyax in the event US Bio
becomes aware or is notified that the insurance described in this Section 14.4
will be materially adversely modified or cancelled in such a manner that US Bio
is no longer in compliance with the requirements of this Section 14.4 and (b) provide
Dyax with proof of such insurance on or before the date such insurance is
renewed for each year.

 

14.5                           Dyax Insurance
Obligations.  During the
Term, Dyax will maintain products liability and commercial general liability
insurance having a limit of not less than [*****] per occurrence,
Combined Single Limit (Bodily Injury and Property Damage), pursuant to one or
more insurance policies with reputable insurance carriers having a Best’s
Rating of A VII or otherwise as reasonably approved by US Bio.  Dyax will designate US Bio as an “additional
insured” under such insurance policy and will obtain a broad form vendor’s
endorsement for products liability for US Bio. 
Within thirty (30) days after the Effective Date, Dyax will provide to
US Bio a certificate of insurance indicating that such obligations have been
satisfied.  As a condition precedent to
the effectiveness of this Agreement, Dyax will execute the form of Continuing
Guaranty and Indemnification Agreement (the “Continuing Guaranty”) with
AmerisourceBergen Corporation attached hereto as Exhibit E.

 

15.                               Term and Termination.

 

15.1                           Term. Unless earlier
terminated in accordance with the terms hereof, the term of this Agreement
(the “Term”) shall (i) commence as of the Effective Date and will continue
in effect for an initial period of three (3) years (the “Initial Term”),
and (ii) automatically renew for subsequent periods of [*****] (each, a “Renewal Term”), unless either party provides written notice to the other at least [*****] prior to the end
of the Initial Term or then-current Renewal Term that it  does not wish to renew.  The parties will work together in good faith
to discuss and agree upon any appropriate fee adjustments at least [*****] prior to
expiration of the Initial Term (or any subsequent Renewal Terms).

 

15.2                           Termination.  In addition to any other provision of this
Agreement providing for termination hereof, this Agreement may be terminated as
follows:

 

(a)                                  Termination by Dyax For Convenience.  Dyax may terminate this Agreement for
convenience, without cause, upon [*****] prior written notice of termination to US Bio; provided, that,
upon any such termination that occurs prior to the second anniversary of the
Effective Date, Dyax shall pay US Bio the following amount within [*****] following the
effective date of termination: (i) [*****] if prior to the first anniversary of the Effective Date; (ii) [*****] if after the
first anniversary of the Effective Date but prior to the second anniversary of
the Effective Date; and (iii) [*****] if after the second anniversary of the Effective Date but prior
to the third anniversary of the Effective Date.

 

(b)                                 Termination For Cause.

 

(i)                                     This Agreement
may be terminated by either party on written termination notice to the other
party in the event of any material breach of this Agreement by the other party
(other than a breach by US Bio of Section 8.2, which is governed by 

 

17

 

clause (ii) below),
which breach is not cured within [*****] days after
delivery of written notice by the non-breaching party specifying such breach
and requiring cure.  Notwithstanding the
right to cure provided by the foregoing sentence, US Bio shall have the right
to cure only two (2) material breaches of any particular obligation
hereunder, and this Agreement may be terminated by Dyax immediately on written
notice to US Bio in the event of any additional material breach of such
obligation by US Bio.

 

(ii)                                  This Agreement
may be terminated by Dyax immediately on written notice to US Bio in the event
of any material breach by US Bio of Section 8.2.

 

(c)                                  Insolvency.  This Agreement may be terminated by either
party immediately upon written notice to the other party in the event of any of
the following events:

 

(i)                                     the institution by the other party of insolvency, receivership or
bankruptcy proceedings or any other material proceedings for the settlement of
the other party’s debts, or the institution against the other party of any such
proceedings that remain undismissed for [*****];

 

(ii)                                  the other party’s making an assignment for the benefit of its
creditors; or

 

(iii)                               the other party’s dissolution.

 

(d)                                 Other Agreements.  In
the event that any of (a) the Distribution Services Agreement of even date
herewith between Dyax and ASD Specialty Healthcare, Inc. or (b) the Distribution Services Agreement of even date herewith
between Dyax and Integrated
Commercialization Solutions, Inc. is terminated for any reason,
then (i) this Agreement may be
terminated by Dyax immediately upon ninety (90) days written notice to US Bio;
and (ii) if not terminated by Dyax, US Bio will notify Dyax of any
applicable adjustment to the fees based on such termination.

 

(e)           Supervening Illegality.

 

(i)                                     This Agreement shall terminate if both:  (A) as a result of the enactment of any
new applicable federal or state law or regulation, or any change in any
existing applicable federal or state law or regulation or any new
interpretation of any applicable federal or state law or regulation by any
legislative body, court or regulatory agency, the performance by a party of any
material obligation under the Agreement would be rendered illegal or any
material provision of the Agreement would be rendered invalid or unenforceable,
and (B) the parties are unable to negotiate a mutually acceptable
amendment to the Agreement pursuant to Section 15.2(e)(iii) below.  If any immaterial provision of this Agreement
is held to be illegal, invalid or unenforceable for any reason, the Agreement
shall be deemed amended to delete such provision, such amendment to apply only
with respect to the operation of the Agreement in the particular jurisdiction
in which such provision is held to be illegal, invalid or unenforceable, 

 

18

 

and
the remainder of the Agreement shall remain in full force and effect and
enforceable in accordance with its terms.

 

(ii)                                  The parties agree that the party affected by the new law or
regulation or the change in law or regulation or the interpretation of a law or
regulation shall use reasonable efforts to give the other party at least [*****] prior written
notice of the effective date of such new law, change, or interpretation.

 

(iii)                               The parties agree that, notwithstanding the foregoing provisions
of this Section, either party may, within ten (10) business days of giving
or receiving notice of the new law, change or interpretation, notify the other
party of its wish to renegotiate the applicable terms of the Agreement (“Renegotiation
Notice”), in which event the parties shall negotiate in good faith, for a
period of sixty (60) days from delivery of the Renegotiation Notice, an
amendment to the Agreement that addresses the portion of the Agreement rendered
illegal, invalid or unenforceable by the new law, change or interpretation
while preserving to the greatest extent possible the original intent of the
Agreement.  If the parties successfully
conclude such negotiations prior to the effective date of the new law, change
or interpretation, the Agreement shall not terminate and shall be amended to
reflect the negotiated terms.  If the
parties are unable to successfully conclude such negotiations prior to the
effective date of the new law, change or interpretation and such effective date
is within the sixty (60) day negotiation period, the Agreement shall be deemed
amended to delete such portion rendered illegal, invalid, or unenforceable,
such amendment to apply only with respect to the operation of the Agreement in
the particular jurisdiction in which such portion is held to be illegal,
invalid or unenforceable, and the remainder shall remain in full force and
effect and enforceable in accordance with its terms.  In the event the parties are unable to
successfully conclude such negotiations within the sixty (60) day negotiation
period, the Agreement shall terminate at the end of the sixty (60) day
negotiation period.

 

15.3         Effect of Termination.  Upon the expiration or earlier
termination of this Agreement:

 

(a)                                  all Confidential
Information received hereunder shall be returned to the disclosing party, or
destroyed, at the disclosing party’s election (provided that the receiving
party may retain one copy to the extent necessary to comply with any
contractual or other legal obligations applicable thereto);

 

(b)                                 all rights
granted to US Bio with respect to the Product shall terminate and US Bio shall
cease in a timely and orderly manner all activities with respect to the selling
and distribution of Product; and

 

(c)                                  unless
terminated by US Bio pursuant to Section 15.2(b), for a period of [*****] following such expiration or early termination, US
Bio and its Affiliates shall provide commercially reasonable assistance in
connection with Dyax’s transition of Product distribution and Hub Services to
Dyax, its Affiliates or any third party selected by Dyax.  

 

19

 

Dyax shall reimburse US Bio
for its reasonable, documented out-of-pocket costs and expenses incurred with
in connection with providing such transition services; provided that, in the
event of a termination due to US Bio’s breach, neither the existence of this
provision nor the fact of Dyax’s agreement to pay for such transition services
shall in any way effect or limit Dyax’s rights or remedies with respect to such
breach.

 

Termination of
this Agreement shall not relieve either party of obligations incurred prior to
termination.  The provisions of Sections
2.3(a)(ii), 2.3(a)(iii), 10.4, 10.5, 10.6, 15.3, 17.10 and 17.11 and Articles
11, 14 and 16, together with and any other provisions which by
their express terms extend beyond the expiration or termination of this
Agreement, shall survive any termination of
this Agreement.

 

15.4                           Termination of
Exclusivity.  In the event
that Dyax has the right to terminate this Agreement for any reason (except
pursuant to Section 15.2(a) (Termination for Convenience), Dyax, on
immediate written notice to US Bio, may terminate Section 2.3(a)(i), which
shall have no further force or effect from and after the delivery of such
notice by Dyax.  In the event that Dyax
terminates this Agreement for convenience pursuant to Section 15.2(a),
then US Bio’s obligations under Sections 2.3(a)(ii) and 2.3(a)(iii) shall
expire one (1) year after the effective date of termination and thereafter
have no further force or effect.

 

16.                               Dispute
Resolution.

 

16.1                           Resolution by
Executives.  Any dispute,
controversy or claim initiated by either party arising out of, or resulting
from the breach or alleged breach by either party of its obligations under this
Agreement (other than bona fide third party actions or proceedings
filed or instituted in an action or proceeding by a third party against a party to this Agreement), whether before
or after termination of this Agreement, shall be in the first instance referred
to the respective chief executive officers of the parties unless such dispute
or claim must be filed to preserve a legal interest or injunctive relief is
required.

 

16.2                           Arbitration.  If chief executive officers (or their
representatives, it being agreed that the chief executive officer of either
party may designate a representative, provided such representative is empowered
with decision making in the dispute)  of the
parties fail to resolve any dispute as provided in Section 16.1 within [*****], then such dispute shall be finally resolved by
binding arbitration as follows:

 

(a)                                  Any dispute that
might arise between the parties relating to or arising from this Agreement
shall be settled by binding arbitration in accordance with the then-prevailing
Commercial Arbitration Rules of the American Arbitration Association (“AAA”),
except where those rules conflict with this provision, in which case this
provision controls. Arbitration shall be conducted before a single arbitrator
selected from the AAA’s National Roster of Arbitrators, each of whom shall be a
lawyer with at least 15 years experience with a law firm or corporate law
department of over 25 lawyers or who was a judge of a court of general
jurisdiction.  Each party shall have the
right to meet and interview the potential arbitrator for no more than one hour
each prior to the selection of an arbitrator. 
The arbitration shall be held, and Dyax and US Bio irrevocably consent
to arbitrate, in a

 

20

 

mutually agreeable
location.  The arbitration shall be
conducted in English.  In rendering the
award the arbitrator must apply the substantive law of the State of Delaware
(except where that law conflicts with this clause); however, the interpretation
and enforcement of this arbitration provision shall be governed by the Federal
Arbitration Act.  The arbitrator shall
render a written opinion setting forth findings of fact and conclusions of law
with the reasons therefor stated.  Under
no circumstances shall the arbitrator award damages in excess of or
inconsistent with any limitations of liability contained in this
Agreement.  Any court with jurisdiction
shall enforce this clause and enter judgment on any award.  US Bio and Dyax will agree upon, within [*****] after the arbitrator is selected or, if they fail to
agree, the AAA will design, procedures that they will follow to assure that the
arbitration will be concluded and the award rendered within no more than eight
months from selection of the arbitrator.

 

(b)                                 The arbitration
proceedings shall be confidential, and neither party shall publicize the nature
of any dispute or the outcome of any arbitration proceedings except to the
extent required by law, provided in such case the party required to make any disclosure
informs the other party of such requirement to allow the other party to seek a
protective order.  The arbitrator shall
issue appropriate protective orders to safeguard each party’s Confidential
Information.

 

(c)                                  Each party has
the right before or during the arbitration to seek and obtain from the
appropriate court provisional remedies such as attachment, an injunction,
replevin, etc., to avoid irreparable harm, maintain the status quo or preserve
the subject matter of the arbitration.

 

17.                               Miscellaneous.

 

17.1                           Relationship of
Parties.  US Bio’s relationship with Dyax
hereunder shall be that of independent contractor, and neither party shall be
considered the agent of, partner of, employee or other member of the workforce
of, or participant in a joint venture with, the other party.  Neither party shall
have authority to bind the other party unless otherwise agreed to in writing by
such parties.

 

17.2                           Notices.  All notices, requests, demands and other
communications required or permitted to be given pursuant to this Agreement
shall be in writing and shall be deemed to have been duly given upon the date
of receipt if delivered by hand, recognized international overnight courier,
confirmed facsimile transmission, or registered or certified mail, return receipt
requested, postage prepaid to the following addresses or facsimile numbers:

 

	
  If
  to Dyax:

  	
   

  	
  Dyax
  Corp.

  
	
   

  	
   

  	
  300
  Technology Square

  
	
   

  	
   

  	
  Cambridge,
  MA 02139

  
	
   

  	
   

  	
  [*****]

  
	
   

  	
   

  	
   

  
	
  If
  to US Bio:

  	
   

  	
  US
  Bioservices Corporation

  
	
   

  	
   

  	
  3101
  Gaylord Parkway

  
	
   

  	
   

  	
  Frisco,
  TX 75034

  

 

21

 

	
   

  	
   

  	
  [*****]

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  with
  a copy to:

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  AmerisourceBergen
  Specialty Group

  
	
   

  	
   

  	
  3101
  Gaylord Parkway

  
	
   

  	
   

  	
  Frisco,
  TX 75034

  
	
   

  	
   

  	
  [*****]

  

 

Either
party may change its designated address, contact person and facsimile number by
notice to the other party in the manner provided in this Section.

 

17.3                           Assignment.  Neither party may assign its rights or
delegate its obligations under this Agreement without the prior written consent
of the other party, except that either party may assign this Agreement to any
of its Affiliates or to a successor in connection with the merger,
consolidation, or sale of all or substantially all of its assets or that
portion of its business pertaining to the subject matter of this Agreement,
with prompt written notice to the other party of any such assignment; provided
that: (i) if such assignee is an Affiliate, the assignor shall responsible
for and liable with respect to all assigned obligations and (ii) if such
assignee is not an Affiliate, (A) the assignee assumes the assignor’s
obligations under the Continuing Guaranty and Indemnification Agreement, and (B) the
assignee has net assets as of the end of its most recently completed fiscal
year equal to or in excess of the net assets of the assignor as of the end of
its most recently completed fiscal year, in each case as set forth in the
audited balance sheet of the assignor and assignee, and (iii) in the case
of an assignment by Dyax, the assignee is not a Competitor to US Bio.  For the purposes of this Section 17.3, a
“Competitor” means any organization, entity or person that competes with US Bio
including but not limited to the following companies and their affiliated
entities: [*****]  Notwithstanding the foregoing, US Bio
acknowledges and agrees that Dyax may perform its obligations and exercise its
rights hereunder through a third party logistics provider.

 

17.4                           Force Majeure. Each party’s
obligation under this Agreement will be excused to the extent any delay or
nonperformance is caused by strikes or other labor disturbance, acts of God,
war, or other conditions beyond the reasonable control of that party, but only
during the duration of such condition.

 

17.5                           Amendment and
Waiver.  This Agreement may be amended,
supplemented, or otherwise modified only by means of a written instrument
signed by both parties.  Any waiver of
any rights or failure to act in a specific instance shall relate only to such
instance and shall not be construed as an agreement to waive any rights or fail
to act in any other instance, whether or not similar.  To be valid, any waiver must be in writing.

 

17.6                           Severability.  In the event any provision of this Agreement
should be held invalid, illegal or unenforceable, the remaining provisions
shall not be affected or impaired and the parties shall use all reasonable
efforts to replace the applicable provision with a valid, legal and enforceable
provision which insofar as practical implements the original intent of such
invalid, illegal or unenforceable provision, provided, however, that if the
parties fail to reach such agreement within 

 

22

 

sixty (60) days, a party whose rights or obligations are materially
adversely affected as a result of a provision being held invalid, illegal or
unenforceable may terminate this Agreement.

 

17.7                           Headings.  All headings used in this Agreement are
inserted for convenience only and are not intended to affect the meaning or
interpretation of this Agreement or any Article or Section hereof.

 

17.8                           Successors and
Assigns.  This Agreement shall be binding
on and shall benefit any and all successors, trustees, permitted assigns and
other successors in interest of the parties.

 

17.9                           Applicable Law;
Disclaimer of Puerto Rico Law 75.

 

(a)                                  This Agreement
shall be construed and enforced in accordance with the laws of the State of
Delaware (excluding the choice of law provisions thereof).

 

(b)                                 The parties
expressly disclaim, to the fullest extent allowed by Applicable Laws, any
application of the Puerto Rico Dealers Act, Law No. 75 of June 1964
(the “Dealers Act”) as amended, and the parties acknowledge that the Dealers
Act shall not apply in the interpretation or enforcement of any of the rights
and obligations of the parties hereto.

 

17.10                     Contract
Interpretation.  The parties
have jointly negotiated this Agreement and, thus, neither this Agreement nor
any provision will be interpreted for or against any party on the basis that it
or its attorney drafted the Agreement or the provision at issue.   When
this Agreement requires approval of one or more parties, such approval may not
be unreasonably withheld or delayed.  Words, regardless of the number and
gender specifically used, will be construed to include any other number,
singular or plural, and any gender, masculine, feminine, or neuter, as the
context requires.  “And” includes “or.”  “Or” is disjunctive but not
necessarily exclusive.  “Including” means “including but not limited to.” Unless
other specifically stated, the term “days” means calendar days.

 

17.11                     Entire
Agreement; No Reliance.  Each
of the parties agrees and acknowledges that this Agreement, including the
Continuing Guaranty and the attachments referred to herein, (i) constitutes
the entire agreement and supersedes all prior and contemporaneous agreements,
understandings, negotiations and discussions, whether oral or written, between
the parties with respect to the subject matter of this Agreement, and (ii) is
not intended to confer any rights or remedies, or impose any obligations, on
any person other than the parties hereto. 
Each of the parties expressly agrees and acknowledges that, other than
those statements expressly set forth in this Agreement, it is not relying on
any statement, whether oral or written, of any person or entity with respect to
its entry into this Agreement or to the consummation of the transactions
contemplated by this Agreement.

 

17.12                     Counterparts.  This Agreement may be executed in multiple
counterparts, each of which shall be deemed an original but all of which
together shall constitute one and the same instrument.  Facsimile execution and delivery of this
Agreement are legal, valid and binding execution and delivery for all purposes.

 

[signature page to follow]

 

23

 

IN WITNESS WHEREOF, the parties hereto have caused
this Agreement to be executed by their duly authorized respective officers as
of the Effective Date.

 

 

	
  US Bioservices Corporation

  	
  Dyax Corp.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Mark O. Johnson

  	
   

  	
  By:

  	
  /s/ Ivana Magovcevic-Liebisch

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Name:

  	
  Mark O. Johnson

  	
  Name:

  	
  Ivana Magovcevic-Liebisch

  
	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
  President

  	
  Title:

  	
  Executive Vice President Corporate Development and General Counsel

  

 

 

AmerisourceBergen
Specialty Group, Inc., a Delaware corporation, agrees that it shall be
financially responsible for any unsatisfied liabilities of US Bioservices
Corporation under this Agreement; provided that any defense or privilege that
may be asserted by US Bioservices Corporation may also be asserted by
AmerisourceBergen Specialty Group, Inc.

 

	
   

  	
  AmerisourceBergen Specialty Group, Inc.

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
  /s/ Mike Mullen

  
	
   

  	
   

  	
   

  
	
   

  	
  Name:

  	
  Mike Mullen

  
	
   

  	
   

  	
   

  
	
   

  	
  Title:

  	
  President

  

 

24

 

LIST
OF EXHIBITS

 

EXHIBIT
A — Product Description

EXHIBIT
B — Initial Statement of Work for Hub Services

EXHIBIT
C — Standard Operating Procedures for Hub Services

EXHIBIT
D — Product Returns Policy

EXHIBIT
E — Continuing Guaranty

 

25

 

EXHIBIT A

Product Description

 

	
  Product Trade Name:

  	
   

  	
  Kalbitor®

  
	
  Generic Name:

  	
   

  	
  ecallantide

  
	
  NDC Number:

  	
   

  	
  47783-101-01

  

 

Kalbitor
is a recombinant protein with high affinity and high specificity for human
plasma kallikrein and is used in the treatment of Hereditary Angioedema (HAE).

 

Kalbitor
is temperature sensitive and must be stored and shipped at 2-8°C (36-42°F).

 

Kalbitor
is packaged in a single carton containing three 1 mL vials and is administered
through three subcutaneous injections.

 

26

 

EXHIBIT B

Initial Statement of Work for Hub
Services

 

[*****]

 

27

 

EXHIBIT C

Standard Operating Procedures for
Hub Services

 

[*****]

 

28

 

EXHIBIT D

Product Returns Policy

 

[*****]

 

29

 

EXHIBIT E

Continuing Guaranty

 

[attached hereto]

 

30Exhibit 10.21

 

DISTRIBUTION SERVICES AGREEMENT

(Wholesale Distribution)

 

This
DISTRIBUTION SERVICES AGREEMENT (“Agreement”), dated as of November 19, 2009
(the “Effective Date”), is entered into by and between DYAX CORP., a Delaware corporation with offices located at 300
Technology Square, Cambridge, Massachusetts 02139 (“Dyax”), and ASD SPECIALTY HEALTHCARE INC., a California
corporation with its primary offices located at 3101 Gaylord Parkway, Frisco,
Texas 75034 (“ASD”).

 

WHEREAS,
Dyax has developed the Product (as defined below);

 

WHEREAS,
in the United States, Dyax intends to secure the regulatory approvals required
in order to promote, market and sell the Product in the United States as a
treatment for patients suffering acute attacks associated with the disease
known as hereditary angioedema (“HAE”);

 

WHEREAS,
ASD is a distributor of therapeutic products and vaccines to health system
pharmacies and alternate-site practitioners throughout the United States; and

 

WHEREAS,
Dyax wishes to engage ASD to distribute the Product to Wholesale Customers (as
defined below) throughout the United States, and ASD wishes to accept such
engagement, all upon the terms and subject to the conditions set forth in this
Agreement.

 

NOW,
THEREFORE, for good and valuable consideration,
the receipt and sufficiency of which are hereby acknowledged, the parties
agree as follows:

 

1.                                      Definitions.

 

As used in this
Agreement, the following capitalized terms shall have the following meanings:

 

1.1                                 “Affiliate”
shall mean any individual, corporation, partnership, association, or business
that directly or indirectly through intermediaries, controls, is controlled by
or is under common control with, a party. An ownership, voting or similar
interest (including any right or option to obtain such an interest)
representing more than 50% of the total interests then outstanding of the
pertinent entity shall constitute “control” for the purposes of this
definition.

 

1.2                                 “Applicable
Laws” shall mean all applicable laws, rules, regulations in the Territory,
including guidelines and guidances promulgated by governmental entities.

 

1.3                                 “Consenting
Facility” shall mean each health care facility designated by Dyax that [*****].

 

1.4                                 “FDA”
shall mean the United States Food and Drug Administration or any successor
agency thereto.

 

1.5                                 “Field”
shall mean all uses in the therapeutic treatment of HAE.

 

1.6                                 “Patient”
shall mean any person diagnosed with HAE.

 

* Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

 

CONFIDENTIAL DOCUMENT

EXECUTION COPY

 

1.7                                 “Product” shall mean Dyax’s proprietary plasma
kallikrein inhibitor, known as internally as DX-88 and generically as
ecallantide, as more formally described on Exhibit A.

 

1.8                                 “REMS Program”
shall mean the Risk Evaluation and Mitigation Program  required
to be implemented under Section 505-1 of the Federal Food, Drug and Cosmetic
Act in connection with the regulatory approval of the Product by the FDA.

 

1.9                                 “SOPs”
shall have the meaning set forth in Section 8.3.

 

1.10                           “Term”
shall have the meaning set forth in Section 13.1.

 

1.11                           “Territory”
shall mean the 50 states of the United States of America, the District of
Columbia and Puerto Rico.

 

1.12                           “Wholesale Customers” shall mean hospital,
institutional and other pharmacies that purchase Product for their own account
for later resale to Patients.  For the
purpose of this Agreement, “Wholesale Customer” shall also include physicians
who purchase Product on a “buy and bill” basis. 
For the avoidance of doubt, (a) all Wholesale Customers must be enrolled
in the REMS Program at the time of sale or distribution of Product thereto by
ASD and (b) Wholesale Customer shall not include specialty pharmacies,
distributors, or other wholesalers.

 

2.                                      Engagement of ASD.

 

2.1                                 Engagement.  Upon the terms and conditions set forth
herein, Dyax hereby engages ASD, on an exclusive basis during the Term (subject
to Section 13.4), to offer for sale, sell and distribute Product to Wholesale
Customers in the Field in the Territory. 
ASD hereby accepts such engagement and shall offer for sale, sell and
distribute Product to Wholesale Customers in the Territory in a professional and responsible manner and in accordance with the terms of
this Agreement and all
Applicable Laws.

 

2.2                                 Authorized Distributor.  In connection with ASD’s engagement under Section
2.1 above, and solely for the limited purpose of compliance with the pedigree
requirements of the Prescription Drug Marketing Act and any similar state laws,
Dyax hereby designates ASD as
an Authorized Distributor of Record (“ADR”) of the Product during the Term.

 

2.3                                 Exclusivity;
Agreement Not to Disadvantage Products.  The parties acknowledge and agree that as a
result of the exclusive nature of the ASD engagement, subject to Section 13.4,
during the Term:

 

(a)                                  Dyax shall not
engage any party other than ASD or its Affiliates to distribute Product to
Wholesale Customers for the Field in the Territory; and

 

(b)                                 ASD shall not
promote any Competing Product in a way that Disadvantages the Product. For the
purpose of the foregoing sentence, “Disadvantage” shall mean any activities
that (X) are intended to encourage, or could reasonably be foreseen to
encourage, the utilization of a Competing Product, such as advertising the Product in a manner that suggests that a Competitive
Product is superior to the Product in terms of acquisition 

 

2

 

price, reimbursement rates,
or efficacy, or (Y) otherwise operate to the disadvantage of the
Product.  For purposes of clarification,
announcing a Competing Product on ASD’s web site, listing product changes for a
Competing Product (such as indication additions or packaging changes) on ASD’s
web site, and providing answers for ASD customers who contact ASD regarding a
Competing Product (including responding to questions including (i) what products ASD stocks for a particular
disease state, (ii) what are the prices of such products, (iii)  what are the indications for such products,
and (iv) what are the differences among storage requirements, physical state
and administration of the products) are normal promotional activities of a
distributor that shall not be considered to Disadvantage the Product.

 

2.4                                 Reserved Rights. Except as
expressly provided in this Agreement, no right, title or interest in or to
Product or any patent, trade secret, trademark or any other intellectual
property right of Dyax or its Affiliates is granted, whether express or
implied, by Dyax to ASD.  In furtherance
of the foregoing and not in limitation thereof, nothing herein shall in any way
limit Dyax’s ability to (i) offer for sale, sell or distribute Product to
Wholesale Customers outside of the Territory, (ii) offer for sale, sell or
distribute Product to Wholesale Customers in the Territory for uses outside of
the Field or (iii) offer for sale, sell or distribute Product to any person or
entity other than a Wholesale Customer, including specialty
pharmacies, either directly or through a third party, anywhere in the world. Except as
expressly provided in this Agreement, no right, title or interest in or to any
patent, trade secret, trademark or any other intellectual property right of ASD
or its Affiliates is granted, whether express or implied, by ASD to Dyax.  By
way of clarification, all proprietary systems, databases and web-based
applications, and any standard operating procedures, work rules, programming,
software, routines, analytic tools, embedded logic or table structures
associated therewith, that have been developed, maintained, utilized and
improved by ASD (or its Affiliates)
in connection with this Agreement are and will remain the property of ASD (or its
Affiliates).

 

2.5                                 Service Level
Commitments.  The parties
to this Agreement desire to define a mutually beneficial relationship between
Dyax and ASD in order to achieve Dyax’s goals of high patient level product
availability, high levels of consumer and pharmacy confidence in the integrity
and quality of the Product, and achievement of a collaborative, transparent,
and cost-effective distribution system. 
In order to achieve the stated goals, ASD agrees to offer for sale, sell
and distribute the Product hereunder in accordance with the key performance
indicators / service level commitments attached hereto as Exhibit B
and incorporated herein by this reference.

 

3.                                      Purchase and Sale of Product.

 

3.1                                 Purchase of Product.  ASD shall (i) purchase Product only from Dyax
and no other supplier, (ii) distribute Product
that it has purchased from Dyax, and (iii) offer for sale, sell and
distribute Product only to Wholesale Customers
for the Field in the Territory.   ASD
shall fill orders for Product only with Product and shall not substitute other
products.

 

3

 

3.2                                 Purchase Price;
Payment Terms.

 

(a)                                  The price
payable by ASD to Dyax for all Product purchased by ASD hereunder (the “Purchase
Price”) shall be [*****].

 

(b)                                 Dyax promptly
shall invoice ASD for the Purchase Price for all Product purchased
hereunder.  All Dyax invoices for Product
shall be due and payable by ASD within [*****] after receipt by ASD provided,
however, [*****].  On all undisputed
balances exceeding [*****] from invoice receipt, ASD shall pay interest equal
to the lesser of (i) [*****] per month and (ii) the maximum allowed by law.

 

3.3                                 Product Pricing.

 

(a)                                  With the exception of sales to certain government Wholesale
Customers, ASD shall have sole discretion to establish the prices
and terms on which ASD sells Product to Wholesale Customers, provided however, that ASD shall not charge Wholesale Customers
more than [*****], excluding
reasonable upcharges associated with the consignment of Product with such
Wholesale Customer and charges for payment by credit card, shipping, sales tax
and other transaction based taxes.

 

(b)                                 Sales to Government Wholesale Customers.  ASD shall make Product
available for purchase by 340B covered entities and government entities
entitled to purchase off the Federal Supply Schedule (“FSS”) at prices below
WAC.  Dyax shall communicate these
discounted prices to ASD quarterly, and shall accept chargeback requests from
ASD in accordance with the procedures set forth in Exhibit C.  ASD shall use commercially reasonable efforts
to ensure that Wholesale Customers claiming the right to purchase at 340B or
FSS prices are eligible to do so prior to making the discounted sale.  If periods of shortage occur, ASD shall not
disproportionately disadvantage either 340B covered entities nor government
organizations entitled to purchase off the FSS in order management.

 

3.4                                 Chargeback and Deduction Policies.  ASD shall abide by Dyax’s policies regarding
chargebacks (“Chargeback and Deduction Policies”) attached hereto as Exhibit C and incorporated by reference herein.  Such policies may be altered from time to
time by Dyax upon written notice to ASD, provided that if any such change is
not acceptable, ASD may terminate this Agreement on [*****] written notice to Dyax.

 

3.5                                 Compliance with Safe Harbor.  To the extent the safe harbors under 42
C.F.R. § 1001.952 are applicable to payments made under this Agreement, the
parties agree to comply with the safe harbors with regard to such payments.

 

4.                                      Delivery
of Product to ASD.

 

4.1                                 Product Orders.  ASD shall submit all Product orders
electronically in the industry standard format in accordance with such procedures
as may be mutually agreed upon by the parties. 
Unless 

 

4

 

otherwise
agreed between the parties, all Product orders shall be submitted in quantities
of 20 units (or multiples of 20 units).

 

4.2                                 Delivery Times.  Dyax shall make commercially reasonable
efforts to ship all ASD orders completely and to have Product from such orders
shipped to ASD within a mutually agreeable schedule of up to five (5) business
days of order placement.  ASD
acknowledges and agrees that Dyax may not be able to fill all orders completely
or within a specified time due to shortages or other causes and such inability
shall not constitute a breach of this Agreement.

 

4.3                                 Product Dating.  Dyax shall ship Product to ASD with at least
[*****] shelf life remaining, unless otherwise agreed in writing by ASD.  [*****]

 

4.4                                 Product Delivery; Risk of Loss.  Dyax
shall deliver all Product Free On Board to ASD’s facility in the
Territory designated in the applicable order. 
For purposes of this Section, the term “Free On Board” means that Dyax
shall bear (i) all costs associated with shipping Product to the ASD designated
facility, and (ii) all risk of loss for Product until its delivery to the
designated ASD facility.  Title to, and
risk of loss of, all Product shall pass to ASD on delivery.

 

4.5                                 Inspection of Product.  ASD shall
examine the Product upon delivery at ASD’s designated facility and shall notify
Dyax in writing within one (1) business day of any problems relating to the
quantity of Product delivered or any defect in any of the Product that is
reasonably discoverable upon visual inspection of the Product without unpacking
of pallets.

 

4.6                                 No Alteration. 
ASD shall not alter the Product in any way, including
the packaging thereof, without Dyax’s written consent (except to remove the
Product from the shipping containers) and shall not alter the Product labeling.

 

4.7                                 Storage
Conditions.  ASD will
maintain Product stored at, and shipped from, its facilities under (i) the
Product storage, shipment and handling requirements set forth in the FDA
approved labeling and  (ii) any
additional requirements mutually agreed upon between ASD and Dyax.  ASD shall notify Dyax
within one (1) business day of any known deviation from such requirements so
that Dyax can determine whether any further action must be taken with respect
to such Product.  Failure of ASD to
notify Dyax promptly of such known deviation shall constitute a breach of this
Agreement by ASD.

 

5.                                      Product Inventories.

 

5.1                                 Inventory Levels.   During
the Term, unless otherwise agreed to by Dyax in writing and subject to Section 5.2,
ASD shall maintain at all times a Warehouse Inventory of Product in an amount
equal to not less than [*****] nor more than [*****] of ASD’s Expected Sales (as
defined herein) to Wholesale Customers.  [*****]

 

5.2                                 Supply Shortages.  ASD shall have no obligation to maintain the
minimum inventory levels described in Section 5.1 if Product is unavailable
from Dyax.

 

5

 

5.3                                 Consignment
Arrangements.  Subject to
the additional terms set forth in Exhibit D, ASD
shall install Product in each Consenting Facility designated by Dyax that has
an existing Cubixx® refrigerated cabinet. 
Furthermore, upon payment by Dyax of the applicable fee specified in Exhibit D, ASD shall install in each Consenting Facility
designated by Dyax a Cubixx refrigerated cabinet (a “Dyax Consignment Unit”).  As between Dyax and ASD, ASD shall be solely
responsible for the maintenance of all Cubixx refrigerated cabinets and Dyax
Consignment Units.  ASD shall use
commercially reasonable efforts to ensure that no product other than Product is
kept or stored in any Dyax Consignment Unit. 
Furthermore, ASD shall use commercially reasonable efforts to ensure
that each Consignment Unit and Cubixx refrigerated cabinet is stocked at all
times with reasonably sufficient amounts of Product to satisfy demand for
product in the applicable Consenting Facility. 
ASD shall reasonably assist Dyax to obtain the consent of each health
care facility designated by Dyax to the installation of a Dyax Consignment Unit
or Cubixx refrigerated cabinet.

 

6.                                      Product
Returns.

 

Dyax
(or its third party logistics provider acting on behalf of Dyax) shall accept
and process returns of Product purchased by ASD hereunder in accordance with
Dyax’s Product Returns Policy, as it may be amended from time to time by
Dyax.  A copy of the Product Returns
Policy in effect as of the Effective Date is attached to this Agreement as Exhibit E.

 

7.                                      Suspension, Recalls and Government Notices.

 

7.1                                 Suspension.  Upon written notification by Dyax to suspend
distribution of Product, ASD immediately shall suspend its distribution of
Product.  If the suspension continues for
more than [*****], Dyax will repurchase the Product in saleable condition held
in inventory by ASD at the price paid for such Product by ASD.  All repurchased Product shall be returned to
Dyax at Dyax’s expense.

 

7.2                                 Recalls.

 

(a)                                  Recalls
Procedures.  Dyax shall
promptly notify ASD of any recalls or market withdrawals initiated by Dyax or
required by the FDA or any other governmental agency.  ASD shall notify Dyax immediately of any
event or circumstance that ASD reasonably believes may necessitate a recall or
market withdrawal.  Upon receipt of
notice of a recall or market withdrawal from Dyax, ASD shall administer such
recall or market withdrawal under the direction of Dyax, including promptly
notifying the affected Wholesale Customers of ASD in accordance with Dyax’s
instructions.  Dyax shall provide ASD
with a form letter to be used in connection with notice of any recall or market
withdrawal, and shall, to the extent practicable, provide ASD the opportunity
to review and comment on such letter.  Dyax
shall be responsible for the mailing, shipping, and reasonable administrative
expenses incurred by ASD in connection with the recall or market withdrawal,
plus a reasonable service fee as mutually agreed upon in advance by the parties
as well as the cost of replacement Product for ASD’s Wholesale Customers,
except to the extent that such recall or market withdrawal arises or results
from (i) the negligence or intentional misconduct of ASD or any of its
permitted agents or employees or (ii) the breach by ASD of this Agreement, in
which event ASD shall bear and be responsible for such costs as well as the 

 

6

 

reasonable, documented,
out-of-pocket expenses of Dyax incurred in connection with such recall or
market withdrawal.

 

(b)                                 Investigations;
Cooperation.  ASD shall
fully cooperate with Dyax in investigating any Product failure that resulted in
the need for a recall or market withdrawal and any reasonable, documented,
out-of-pocket cost involved with such investigation shall be reimbursed by Dyax,
except to the extent that such recall or market withdrawal arises or results
from (i) the negligence or intentional misconduct of ASD or any of its
permitted agents or employees or (ii) the breach by ASD of this Agreement, in
which event ASD shall bear and be responsible for such costs as well as the
reasonable, documented, out-of-pocket expenses of Dyax incurred in connection
with such investigation.

 

7.3                                 Government
Notices.  Each party shall provide the
other with a copy of any correspondence or notices it receives from the FDA, or
other governmental entity specifically relating to the Product or activities
conducted under this Agreement, no later than one (1) business day following
such receipt.  Each party shall also
provide the other with concurrent copies of any responses to any such
correspondence or notices (e.g., a response to an FDA 483 notice, warning
letter, or untitled regulatory letter); provided that Dyax shall review and
approve all such responses by ASD to the extent related to the Product and to
the extent reasonably feasible.  Where
reasonably possible, ASD shall give prior notice to Dyax of any scheduled FDA
or other governmental inspection of ASD’s facilities specifically relating to
the Product, and, if reasonably possible, will afford Dyax the opportunity to
be present at such inspection.

 

8.                                      Additional ASD Obligations and Services.

 

8.1                                 REMS Program.  ASD shall distribute Product
and otherwise conduct all activities under this Agreement in accordance with
the REMS Program and any additional policies Dyax implements and provides in
writing to ASD.

 

8.2                                 Adverse Event
Reporting.  In the event that an adverse
experience, as that term is defined at 21 C.F.R. § 600.80 (as such provision
may be amended from time to time), with regard to the Product is reported to
ASD, ASD shall ensure that all applicable safety and other relevant information
relating to the Product that is obtained during the course of any interaction
with patients, healthcare providers, or other individual, is communicated and
maintained in accordance with Applicable Laws. 
ASD shall notify Dyax of any adverse drug experiences with regard to the
Product within three (3) business days after its first receipt; provided
however, that any information relating to a serious adverse experience (SAE),
as that term is defined at 21 C.F.R. § 600.80 (as such provision may be amended
from time to time), shall be provided to Dyax within one (1) business day after
its first receipt.  ASD shall also make
all reasonable efforts to assist Dyax with any follow-up investigation
necessary to comply with Applicable Laws with respect the reporting of adverse
drug experiences relating to the Product; provided, that ASD will not be
responsible for reporting of any adverse events to the FDA.  Dyax and ASD will ensure that appropriate
SOPs (as defined in Section 8.3) regarding adverse experiences are established
and/or maintained and regularly reviewed to ensure compliance in accordance
with the terms of this Agreement and Applicable Laws.  Dyax and ASD will ensure that all staff
involved in these activities is appropriately trained and records of such
training are maintained.

 

7

 

8.3                                 Standard
Operating Procedures.  ASD shall
conduct all activities under this Agreement in accordance with all Standard
Operating Procedures (“SOPs”) applicable to such activities, as established and
approved in writing by the parties from time to time.    Any material changes to such SOPs or any
new SOPs, to the extent that they specifically relate exclusively to Dyax or
the Product (and not the general processes of ASD or products of other ASD
clients), shall be subject to the prior written consent of Dyax.  Notwithstanding anything to the contrary
contained in this Agreement or elsewhere, during the Term of this Agreement,
Dyax shall be permitted, upon its reasonable request, to review all SOPs at ASD’s
facility.  Except for SOPs that are
specific and exclusive to Dyax Product (“Dyax SOPs”), the SOPs are confidential
and proprietary to ASD and shall not be disclosed by Dyax to any third
party.  The parties acknowledge and agree
that the Dyax SOPs are the property of Dyax and, upon termination or expiration
of this Agreement, ASD will deliver such SOPs to Dyax.  Upon termination of this Agreement, any of
ASD’s internal standard operating procedures (excluding Dyax SOPs) in Dyax’s
possession will be returned to ASD or (at ASD’s election) destroyed by Dyax,
with Dyax providing ASD with a written certification of destruction.

 

8.4                                 No Subcontracting
or Subdistribution. All obligations and services to be performed by ASD
under this Agreement shall be solely performed by ASD and ASD shall not
outsource or subcontract any of its obligations hereunder without Dyax’s prior
written consent, except to an affiliate of ASD.

 

8.5                                 Applicable Laws and Regulations.  ASD shall conduct all
activities under this Agreement in compliance with
all Applicable Laws, including federal and state wholesale and pedigree
laws, laws relating to the promotion of prescription medicines including the
prohibition of off-label promotion, federal and state laws protecting the
privacy of patient medical information (including HIPAA if applicable), federal
and state anti-kickback laws and regulations, laws relating to the disposal of
pharmaceutical products and hazardous wastes, and all applicable professional
and industry standards and good business practices.  If Dyax reasonably determines that ASD has
conducted activities under this Agreement in
a manner that could potentially compromise public health or safety, then Dyax
may terminate this Agreement immediately, and whether or not Dyax terminates
this Agreement, may pursue all other legal remedies available to it.

 

ASD shall provide
Dyax a copy of its state and local registrations and provide copies of new
registrations to Dyax prior to expirations. ASD promptly shall report to Dyax
any written notice it receives in connection with an administrative, civil,
criminal or other actions by local, state or federal authorities against ASD
and its employees regarding alleged violations of Applicable Laws that relate
to the services under this Agreement or to the Product.  ASD shall comply with the guidelines for
distributing to Disproportionate Share Hospitals, as defined in the Veteran’s
Health Care Act of 1992 (also known as Public Law 102-585), Section 602.

 

8.6                                 Product Promotion.  ASD will not
provide any information regarding the safety, effectiveness, or use of Product
to Wholesale Customers or other persons or entities except as approved in
advance in writing by Dyax.  ASD may
provide information on its own distribution services to its Wholesale Customers
in accordance with ASD standard business practices, including informing its
Wholesale Customers of pricing available for the Product and other products
distributed by ASD.  ASD 

 

8

 

warrants that any information
it provides to its Wholesale Customers regarding Product or its services will
be truthful and non-misleading and will comply with all Applicable Laws.

 

8.7                                 Discounts.  To the extent required by Applicable Laws, including 42 U.S.C. §§ 1320a-7b(b) and in
conformance with the standards set forth in 42 C.F.R. § 1001.952(h) for safe
harbor protection, ASD shall advise and inform each of its Wholesale Customers
to fully report, as required by law or contract, any discounts, rebates, or
reductions in prices on Product and provide the discount information supplied
by ASD to the Department of Health and Human Services or a state agency upon
request, consistent with the requirements of 42 U.S.C. § 1320a-7b(b) and 42
C.F.R. § 1001.952(h).

 

8.8                                 Diversion.  ASD shall notify Dyax in writing promptly
within one (1) business day of learning of information to suggest that any
person or entity is diverting or attempting to divert Product.  For the purposes of this Section 8.8, “diverting” means
the unauthorized sale, distribution, purchase, receipt, or handling of
Product.  Dyax
may immediately terminate this Agreement upon written notice if ASD has
purchased Product from sources other than Dyax.

 

9.                                      Reports and Records.

 

9.1                                 EDI Reports.  ASD shall prepare and deliver to Dyax the
following reports utilizing (i) the reporting and parameters recognized by the
American National Standards Institute (“ANSI”), (ii) the Electronic Data
Interchange (“EDI”) guidelines established by the Healthcare Distribution
Management Association (“HDMA”), and (iii) any required specifications from
Dyax, which may change from time to time with reasonable notice to ASD:

 

(a)                                  EDI 844.  The HDMA Product Transfer Account Adjustment
(“EDI 844”) shall be submitted to Dyax in accordance with Chargeback and
Deduction Policies listed in Exhibit C;

 

(b)                                 EDI 850.  The HDMA Product Purchase Order (“EDI 850”)
shall be submitted to Dyax in accordance with such procedures as may be
mutually agreed upon by the parties;

 

(c)                                  EDI 852.  Inventory Level and Status Report (“EDI 852”)
shall be submitted to Dyax on a daily basis. 
ASD shall provide Dyax the EDI 852 information in a readable format such
as MS Excel;

 

(d)                                 EDI 867.  The HDMA Product Transfer and Resale Report (“EDI
867”) shall be submitted to Dyax on a weekly basis, by no later than 11:59 p.m.
on Monday for the previous business week.  ASD shall provide Dyax the EDI 867 information
in a readable format such as MS Excel; and

 

(e)                                  Other Data Reports.
Additional HDMA reports submitted and/or received, as applicable, shall include
but are not limited to the following: 
Invoices (“EDI 810”), Electronic Funds Transfer (“EDI 820”), Electronic Chargeback (“EDI 844”), Price Authorizations (“EDI 845”) Chargeback
Reconciliations (“EDI 849”), Purchase Order Acknowledgements (“EDI 855”), 

 

9

 

Advance
Shipment Notices (“EDI 856”), Return Merchandise Authorizations (“EDI 180”) and
the Debit/Adjustment Memo (“EDI 812”).  The foregoing
Data Reports shall be provided to Dyax on a weekly basis.

 

In the event that critical internal support systems
and electronic communication links, including EDI, are not available for three (3)
consecutive business days, the parties will cooperate to promptly implement
substitute procedures to document the information customarily sent by EDI and
prevent interruptions to each other’s business. 
ASD shall include sufficient data in the inventory and sales reports so
that Dyax can determine and evaluate the on-hand and on-order inventory,
purchases, returns and chargebacks made by government customers.

 

9.2                                 Activity Reports.  In addition to any specific reports that ASD
may be required to deliver to Dyax under this Agreement, ASD shall provide to
Dyax all information and reports related to its activities with respect to the
Product that are reasonably requested by Dyax; provided that ASD shall be fully
reimbursed by Dyax for any additional expense incurred in connection with the
preparation and delivery of such information and/or reports.

 

9.3                                 Ownership and
Use of Data.  Subject to
Applicable Laws, Dyax shall have the following rights with respect to
information and data relating to Product, the sale of Product to Wholesale
Customers and the use by Product of Patients obtained, maintained, generated or
furnished by ASD to Dyax in connection with performing ASD’s obligations
hereunder, including such data and information contained in the reports
delivered pursuant to Sections 9.1 and 9.2:

 

(a)                                  With respect to
all reports provided by ASD to Dyax under this Agreement (including this Section
9), Dyax shall own and have the right to use all such reports and all such
information shall be deemed to be Dyax Confidential Information; and

 

(b)                                 ASD shall own all sales and distribution data generated through
its performance of this Agreement and grants Dyax a non-exclusive, perpetual
right to use such data for its internal purposes.

 

(c)                                  With respect to
all information and data not covered by Section 9.3(a) and (b), Dyax shall have
a right to use any and all information and data,
for any purpose as permitted by law or, to the extent such data contain PHI, as
permitted by the applicable patient’s written authorization.

 

9.4                                 Records.  ASD shall keep complete and accurate books
and records pertaining to ASD’s activities under this Agreement.  Such books and records shall be retained for
at least [*****] after the
expiration or termination of this Agreement or for such longer period as may be
required by Applicable Law.

 

9.5                                 Audits.  Dyax, at its expense, from time to time may
perform, or have an independent third party auditor (subject to execution of a
mutually agreeable nondisclosure agreement) perform, audits of the records
maintained pursuant to Section 9.4 and may observe, or have an independent
third party auditor observe, the performance by ASD of its activities hereunder
to verify the status of Product and ensure compliance with the terms of this
Agreement.  Dyax shall provide ASD with
at

 

10

 

least
ten (10) business days advance notice of such audits or observations, and shall
conduct any audit or observation during normal business hours in a manner that
does not interfere with ICS’s normal business operations. ASD shall make
available relevant records that do not contain information pertaining to ASD’s
other suppliers, customers or products and permit such observations.  Dyax and ASD shall discuss the results of any
such audits or observations and ASD shall implement all corrective measures reasonably
requested by Dyax.  All audits shall be
reasonable in time and scope.

 

10.                               Confidentiality.

 

10.1                           Confidential
Information.  All
confidential, non-public documents and other information disclosed to a party
by or on behalf of the other party pursuant to this Agreement, which includes
but is not limited to information concerning prices, fees and proposals,
operating and sales data, quantities purchased by any customer, information
about processes (including SOPs), systems, strategic plans, business plans,
financial information, customer information, information concerning patients or
physicians, methods, databases, technology (including software and all source
code), and any other information or materials prepared or derived from such
information (collectively, “Confidential Information”), shall, subject to
Sections 10.2 and 10.3, be held by the receiving party in strict confidence and
not disclosed either directly or indirectly to any third party (other than
affiliates, advisors and consultants who have a need to know such information
and who are subject to obligations of confidentiality at least as onerous as
those set forth herein) and shall only be used for purposes of fulfilling the
receiving party’s obligations, or exercising its rights, under this Agreement.   Notwithstanding the foregoing, all data and
information owned by Dyax pursuant to Section 9.3 shall be the Confidential
Information of Dyax and not ASD, and regardless of the party that discloses
such Confidential Information hereunder, Dyax shall be deemed the disclosing
party, and ASD shall be deemed the receiving party, with respect to such
Confidential Information.  The terms and
conditions of this Agreement and any amendments or addenda thereto shall be
deemed the Confidential Information of each party.

 

10.2                           Exclusions from
Confidentiality. 
Notwithstanding anything to the contrary in this Agreement, the
receiving party shall have no liability to the disclosing party for the use or
disclosure of any Confidential Information that the receiving party can
establish by written documentation to:

 

(a)                                  have been
publicly known prior to disclosure by the disclosing party of such information
to the receiving party;

 

(b)                                 have become
publicly known without fault on the part of the receiving party, subsequent to
disclosure to the receiving party;

 

(c)                                  have been
received by the receiving party at any time from a source, other than the
disclosing party, lawfully having possession of and the right to disclose such
information;

 

(d)                                 have been
otherwise known by the receiving party prior to disclosure by the disclosing
party to the receiving party of such information; or

 

11

 

(e)                                  have been
independently developed by the receiving party without use of information
disclosed by the Disclosing Party.

 

10.3                           Required
Disclosure.  A party
receiving Confidential Information may disclose such Confidential Information
if required to do so by a court (or other governmental agency or stock exchange
of competent jurisdiction), any governmental body or as required under any
Applicable Laws; provided that (i) the party required to disclose such
Confidential Information provides prompt notice of such pending disclosure to
the disclosing party so that the disclosing party can seek a protective order
or to prevent such disclosure, and (ii) the party required to disclose such
Confidential Information shall exercise reasonable efforts to ensure that the
information is accorded confidential treatment by the court or other governmental
agency or stock exchange.

 

10.4                           Survival of
Confidentiality Obligations.  The provisions of this Section 10 shall
survive for a period of [*****] following the expiration or termination of this
Agreement.

 

10.5                           Injunctive Relief.  Each party acknowledges that
the failure by the Receiving Party to comply with any of the provisions of this
Section 10 will result in irreparable injury and continuing damage to the
disclosing party for which there will be no adequate remedy at law and that, in
the event of a failure of the receiving party so to comply, the disclosing
party shall be entitled to such preliminary and permanent injunctive relief as
may be necessary to ensure compliance with all the provisions of this Section 10
without having to prove actual damages or to post a bond.

 

11.                               Additional
Representations, Warranties and Covenants.

 

11.1                           Authorization.  Each party represents and warrants to the
other party that it has the legal right and power to enter into this Agreement,
to extend the rights and licenses granted to the other in this Agreement, and
to fully perform its obligations hereunder, and that the performance of such
obligations will not conflict with its charter documents or any agreements,
contracts, or other arrangements to which it is a party. Furthermore, no
approvals, consents, orders or authorizations of or designation, registration,
declaration or filing with any governmental authority (within the Field in the
Territory) is required for either party’s performance of its obligations under
this Agreement, other than any approvals that have been obtained already or
will be obtained in the ordinary course of the performance of such obligations.

 

11.2                           No Other Agreements.  Each
party represents and warrants to the other that this Agreement is not
dependent on, and does not operate in conjunction with (either explicitly or
implicitly), any other arrangement between Dyax and ASD.

 

11.3                           Dyax Representations and Warranties.  Dyax hereby
represents and warrants to ASD that, at the time of delivery of Product by Dyax
to ASD hereunder: (a) such Product shall not in any material respect be
adulterated, misbranded or otherwise prohibited within the meaning of the
Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§ 301 et. seq., as amended and
in effect at the time of delivery (the “Act”), or within the meaning of any
applicable state or local law; (b) such Product will be merchandise that may be
introduced and delivered into interstate commerce under the provisions of Section
301 of the Act or Section 351 of the Public Health Service Act; (c) Dyax (or as
applicable its designated third-party logistics provider) has and will
maintain, in full force and 

 

12

 

effect, all licenses and
permits required under Applicable Laws for Dyax to sell and distribute such
Product under this Agreement; (d) such Product will be the subject of a duly
approved Biologics License Application
and may be legally transported or sold under Applicable Laws; (e) such Product
will have been approved by each applicable governmental authority for
commercial sale and shipment of such Product within the Territory; and (f) Dyax
either (i) owns or holds the duly
approved Biologics License Application, as such term is used in the Public
Health Service Act, Title 21, United States Code, as amended for such Product,
or (ii) is otherwise considered the “manufacturer” of such Product within the
meaning of any applicable federal, state or local law relating to pedigrees.

 

11.4                           Product Pricing.  ASD represents and warrants
that:

 

(a)                                  it will refrain
from doing anything that would impede Dyax from meeting any reporting
obligations with respect to Product pricing that Dyax may have under Applicable
Laws;

 

(b)                                 ASD will
properly report the Product sales price to the customer on the invoices or
statements submitted by ASD to Dyax; and

 

(c)                                  no discount
provided or other payment made pursuant to this Agreement is intended in any
way as a discount related to a drug formulary and has not been negotiated or
discussed between the parties in connection with any drug formulary.

 

To the extent required under Applicable Laws, ASD
will report the discounts to appropriate Federal health care programs, and in
any event, will promptly disclose such discounts if requested by a government
agency.

 

11.5                           Federal Programs.  ASD represents,
warrants and covenants to Dyax that (a) neither ASD nor
any of its Affiliates that perform activities under this Agreement has been
debarred or is subject to debarment pursuant to Section 306 of the Act or
listed on either Excluded List (as defined herein), and (b) neither ASD nor any
of its Affiliates that perform activities under this Agreement will knowingly
(after reasonable investigation) use in any capacity, in connection with the
services to be performed under this Agreement, any person who has been debarred
pursuant to Section 306 of the Act, or who is the subject of a conviction
described in such section, or listed on either Excluded List.  ASD shall inform Dyax in writing immediately if
it or any person who is performing services hereunder is debarred or is the
subject of a conviction described in Section 306 of the Act or listed on either
Excluded List, or if any action, suit, claim, investigation or legal or
administrative proceeding is pending or, to the best of ASD’s knowledge, is
threatened, relating to the debarment or conviction Section 306 of the Act, or
listing on either Excluded List, of ASD or any person performing services
hereunder.  “Excluded Lists” means the
Department of Health and Human Service’s List of Excluded Individuals/Entities
and the General Services Administration’s Lists of Parties Excluded from
Federal Procurement and Non-Procurement Programs.

 

11.6                           Prescriber Identifiable Laws.  Dyax warrants that it will
not use or disclose any information provided by ASD in a manner inconsistent
with any Applicable Laws, including any laws relating to the identity of any
prescriber.  ASD warrants that it will
not disclose any information to Dyax in contravention of any Applicable Laws,
including any laws relating to the identity of any prescriber.

 

13

 

11.7                           ASD/Licensure.  ASD represents and warrants that it now has
and shall maintain in full force during the Term all applicable federal and
state wholesaler and other licenses or approvals required under Applicable Laws
and regulations to fulfill its obligations under this Agreement in each state
in the Territory, the District of Columbia and Puerto Rico.  ASD promptly shall notify Dyax of any
denials, revocations or suspension of license or registrations by any state or
federal agency or any other regulatory authority in the Territory, or any
written notice from a governmental body proposing such a denial, revocation or
suspension of a license or registration. 
ASD shall promptly provide Dyax with notice of any material
communications with pharmacy and/or wholesaler licensing boards which relate to
potential problems with facilities, operations, contractors or procedures used
by ASD in distribution of the Product, including notices of inquiries,
investigations or inspections and resulting findings, except that in no event
shall ASD be required to disclose information concerning its other suppliers or
customers or the products of such other suppliers.

 

11.8                           No Other
Warranties.  Except as
expressly provided herein and in the Continuing Guaranty, neither party hereto
makes any representations or warranties to the other party, express or implied,
either in fact or by operation of law, by statute or otherwise, and each party
specifically disclaims any express or implied representations and warranties of
merchantability or fitness for a particular purpose.

 

12.                               Liability, Indemnification and Insurance.

 

12.1                           Remedies.

 

(a)                                  Generally.  Rights and remedies under this Agreement are
cumulative and in addition to any other available rights or remedies under any
other agreement, at law or in equity.

 

(b)                                 Equitable Relief.  If either party violates or threatens to
violate any provision of this Agreement, the other party may suffer irreparable
harm and its remedies at law may be inadequate. 
Accordingly, the other party may seek equitable relief.

 

14

 

12.2                           Indemnification.

 

(a)                                  Indemnification
by ASD.  ASD shall indemnify, defend,
and hold harmless Dyax and its Affiliates and its and their respective
directors, officers, employees, representatives and agents and their respective
successors, heirs and assigns (the “Dyax Indemnitees”) against any liability,
damage, loss, penalty, fine or expense (including reasonable attorneys fees and
expenses of litigation) (collectively, “Losses”) incurred by or imposed upon
the Dyax Indemnitees or any of them in connection with any claims, suits,
demands, investigations, enforcement actions, or judgments, in each case
initiated by a third party (including any governmental or regulatory agency)
(collectively, “Third Party Claims”) which arise out of: (a) the gross
negligence or willful misconduct of ASD in connection with this Agreement; or (b)
the breach of this Agreement by ASD, in each case except for those Losses for
which Dyax has an obligation to indemnify ASD pursuant to Section 12.2(b), as
to which Losses each party shall indemnify the other to the extent of its respective
liability for such Losses.

 

(b)                                 Indemnification
by Dyax.  Dyax shall indemnify, defend,
and hold harmless ASD and its Affiliates and its and their respective
directors, officers, employees, representatives and agents and their respective
successors, heirs and assigns (the “ASD Indemnitees”) against any Losses
incurred by or imposed upon ASD Indemnitees or any of them in connection with
any Third Party Claims which arise out of: (a) the negligence or willful
misconduct of Dyax in connection with this Agreement; (b) the breach of this
Agreement by Dyax, (c) any claims of patent, trademark, copyright or other
infringement related to Products, or (d) the storage, handling, use, non-use,
demonstration, consumption, ingestion, digestion, manufacture, production and
assembly of Products and their transportation to ASD (except to the extent that
such activities are conducted on Dyax’s behalf by an Affiliate of ASD), in each
case except for those Losses for which ASD has an obligation to indemnify Dyax
pursuant to Section 12.2(a), as to which Losses each party shall indemnify the
other to the extent of its respective liability for such Losses.

 

(c)                                  Indemnification
Procedure.  A party that
intends to claim indemnification under this Section 12.2 (the “Indemnitee”)
shall:  (i) promptly notify the
indemnifying party (the “Indemnitor”) in writing of any Third Party Claim in
respect of which the Indemnitee or any of its Affiliates or any of their
respective directors, officers, employees, representatives, agents or their
respective successors, heirs or assigns intend to claim such indemnification
hereunder; (ii) provide the Indemnitor sole control of the defense and/or
settlement thereof with counsel reasonably satisfactory to the Indemnitee; provided, however, that the Indemnitee reserves the right to retain its
own counsel to defend itself in, but not control the defense of, such suit, at
its own expense, unless (a) the interests of the Indemnitee and the Indemnitor
in the suit conflict in such a manner and to such extent as to require,
consistent with applicable standards of professional responsibility, the
retention of separate counsel for the Indemnitee, in which case, the Indemnitor
shall pay for one separate counsel chosen by the Indemnitee or (b) the
Indemnitor shall not have employed attorneys reasonably satisfactory to the
Indemnitee to defend any action within a reasonable time after notice of
commencement of such action and (iii) provide the Indemnitor, at the
Indemnitor’s request and expense, with 

 

15

 

reasonable assistance and
full information with respect thereto.  Neither the Indemnitor nor the Indemnitee shall be responsible to or
bound by any settlement made by the other without its prior written consent,
which shall not be unreasonably withheld or delayed.  Without limiting the foregoing provisions of
this Section 12.2(c), the Indemnitor shall keep the Indemnitee reasonably
informed of the progress of any claim, suit or action under this Section 12.2
and the Indemnitee shall have the right to participate in any such claim, suit
or proceeding with counsel of its choosing at its own expense, but the
Indemnitor shall have the sole right to control the defense or settlement
thereof in accordance with the terms of this Section 12.2(c).

 

12.3                           Limitation of Liability.

 

(a)                                  Neither party shall be liable to the other for special, exemplary,
consequential, incidental (including lost or anticipated revenues or profits),
indirect or punitive damages arising from the performance or nonperformance of
such party under this Agreement whether such claim is based on contract, tort
(including negligence) or otherwise, even if an authorized representative of
such party is advised of the possibility or likelihood of same.

 

(b)                                 Notwithstanding the exclusions and limitations of liability set forth in Section
12.3(a) above, such exclusions and limitations shall not apply to: (i) either
party’s indemnification obligations pursuant to Section 12.2; or (ii) either
party’s breach of the party’s confidentiality obligations pursuant to Article 10.

 

12.4                           ASD Insurance
Obligations.  During the
Term, ASD shall maintain the following minimum levels of insurance:

 

(a)                                  Employer’s
liability insurance with a limit of $[*****] for bodily injury by accident per
person, $[*****] for bodily injury by accident, all persons and $[*****] bodily
injury by disease policy limit;

 

(b)                                 Commercial
general liability insurance, including personal injury blanket contractual
liability and broad form property damage, with a $[*****] combined single
limit;

 

(c)                                  Umbrella
liability insurance in the amount of $[*****] per occurrence and aggregate; and

 

(d)                                 Property
insurance covering the business property of ASD and others while at any unnamed
location in the amount of $[*****].

 

The insurance required by this Section 12.4 may be
made up through a combination of self-insured retention and traditional
insurance.  Throughout the Term, ASD
shall (a) provide prompt written notice to Dyax in the event ASD becomes aware
or is notified that the insurance described in this Section 12.4 will be
materially adversely modified or cancelled in such a manner that ICS is no
longer in compliance with the requirements of Section 12.4, and (b) provide
Dyax with proof of such insurance on or before the date such insurance is
renewed for each year.

 

16

 

12.5                           Dyax Insurance
Obligation; Continuing Guaranty.  During the Term, Dyax will maintain products
liability and commercial general liability insurance having a limit of not less
than [*****] per occurrence, Combined Single Limit (Bodily Injury and Property
Damage), pursuant to one or more insurance policies with reputable insurance
carriers having a Best’s Rating of A VII or otherwise as reasonably approved by
ASD.  Dyax will designate ASD and its
Affiliates as an “additional insured” under such insurance policy and will
obtain a broad form vendor’s endorsement for products liability for ASD.  Within thirty (30) days after the Effective
Date, Dyax will provide to ASD a certificate of insurance indicating that such
obligations have been satisfied.  As a
condition precedent to the effectiveness of this Agreement, Dyax will execute
the form of Continuing Guaranty and Indemnification Agreement (the “Continuing
Guaranty”) with AmerisourceBergen Corporation attached hereto as Exhibit F.

 

13.                               Term and Termination.

 

13.1                           Term. Unless earlier
terminated in accordance with the terms hereof, the term of this Agreement
(the “Term”) shall (i) commence as of the Effective Date and will continue in effect
for an initial period of three (3) years (the “Initial Term”), and (ii) automatically
renew for subsequent periods of [*****] (each, a “Renewal Term”), unless either party provides written notice to the other at least [*****] prior to the end of the Initial Term or then-current Renewal Term
that it does not wish to renew.  The
parties will work together in good faith to discuss and agree upon any
appropriate fee adjustments at least three months prior to expiration of the
Initial Term.

 

13.2                           Termination.  In addition to any other provision of this
Agreement providing for termination hereof, this Agreement may be terminated as
follows:

 

(a)                                  Termination by Dyax For Convenience.  Dyax may terminate this Agreement for convenience,
without cause, upon [*****]
prior written notice of termination to ASD.

 

(b)                                 Termination For Cause.

 

(i)                                     This Agreement
may be terminated by either party on written termination notice to the other
party in the event of any material breach of this Agreement by the other party
(other than a breach by ASD Section 8.1, which is governed by clause (ii) below),
which breach is not cured within [*****] after delivery of written notice by
the non-breaching party specifying such breach and requiring cure.  Notwithstanding the right to cure provided by
the foregoing sentence, ASD shall have the right to cure only two (2) material
breaches of any particular obligation hereunder, and this Agreement may be
terminated by Dyax immediately on written notice to ASD in the event of any
additional material breach of such obligation by ASD.

 

(ii)                                  This Agreement
may be terminated by Dyax immediately on written notice to ASD in the event of
any material breach by ASD of Section 8.1.

 

(c)                                  Insolvency.  This Agreement may be terminated by either
party immediately upon written notice to the other party in the event of any of
the following events:

 

17

 

(i)                                     the institution by the other party of insolvency, receivership or
bankruptcy proceedings or any other material proceedings for the settlement of
the other party’s debts, or the institution against the other party of any such
proceedings that remain undismissed for [*****];

 

(ii)                                  the other party’s making an assignment for the benefit of its
creditors; or

 

(iii)                               the other party’s dissolution.

 

(d)                                 Other Agreements.  In the event that any of (a) the Distribution Services
Agreement of even date herewith between Dyax and US BIOSERVICES CORPORATION, or (b) the Distribution Services Agreement of even date
herewith between Dyax and Integrated
Commercialization Solutions, Inc. is terminated for any reason, then (i)
this Agreement may be
terminated by Dyax immediately upon written notice to ASD; and (ii) if not
terminated, ICS will notify Dyax of any applicable adjustment to Fees based
upon such termination.

 

(e)                                  Supervening Illegality.

 

(i)                                     This Agreement shall terminate if both:  (A) as a result of the enactment of any new
applicable federal or state law or regulation, or any change in any existing
applicable federal or state law or regulation or any new interpretation of any
applicable federal or state law or regulation by any legislative body, court or
regulatory agency, the performance by a party of any material obligation under
the Agreement would be rendered illegal or any material provision of the
Agreement would be rendered invalid or unenforceable, and (B) the parties are
unable to negotiate a mutually acceptable amendment to the Agreement pursuant
to Section 13.2(e)(iii) below.  If any
immaterial provision of this Agreement is held to be illegal, invalid or
unenforceable for any reason, the Agreement shall be deemed amended to delete
such provision, such amendment to apply only with respect to the operation of
the Agreement in the particular jurisdiction in which such provision is held to
be illegal, invalid or unenforceable, and the remainder of the Agreement shall
remain in full force and effect and enforceable in accordance with its terms.

 

(ii)                                  The parties agree that the party affected by the new law or
regulation or the change in law or regulation or the interpretation of a law or
regulation shall use reasonable efforts to give the other party at least [*****] prior written notice of the effective date of such new law,
change, or interpretation.

 

(iii)                               The parties agree that, notwithstanding the foregoing provisions
of this Section, either party may, within ten (10) business days of giving or
receiving notice of the new law, change or interpretation, notify the other
party of its wish to renegotiate the applicable terms of the Agreement (“Renegotiation
Notice”), in which event the parties shall negotiate in good faith, for a
period of sixty (60) 

 

18

 

days from
delivery of the Renegotiation Notice, an amendment to the Agreement that
addresses the portion of the Agreement rendered illegal, invalid or
unenforceable by the new law, change or interpretation while preserving to the
greatest extent possible the original intent of the Agreement.  If the parties successfully conclude such
negotiations prior to the effective date of the new law, change or
interpretation, the Agreement shall not terminate and shall be amended to
reflect the negotiated terms.  If the
parties are unable to successfully conclude such negotiations prior to the
effective date of the new law, change or interpretation and such effective date
is within the sixty (60) day negotiation period, the Agreement shall be deemed
amended to delete such portion rendered illegal, invalid, or unenforceable,
such amendment to apply only with respect to the operation of the Agreement in
the particular jurisdiction in which such portion is held to be illegal,
invalid or unenforceable, and the remainder shall remain in full force and effect
and enforceable in accordance with its terms. 
In the event the parties are unable to successfully conclude such
negotiations within the sixty (60) day negotiation period, the Agreement shall
terminate at the end of the sixty (60) day negotiation period.

 

13.3                           Effect of Termination.  Upon the expiration or
earlier termination of this Agreement:

 

(a)                                  all Confidential
Information received hereunder shall be returned to the disclosing party, or
destroyed, at the disclosing party’s election (provided that the receiving
party may retain one copy to the extent necessary to comply with any
contractual or other legal obligations applicable thereto);

 

(b)                                 all rights
granted to ASD with respect to the Product shall terminate and ASD shall cease
in a timely and orderly manner all activities with respect to the selling and
distribution of Product; and

 

(c)                                  unless
terminated by ASD pursuant to Section 13.2(b) above (Material Breach), for a
period of [*****] following such expiration or early termination, ASD and its
Affiliates shall provide commercially reasonable assistance in connection with
Dyax’s transition of Product distribution to Dyax, its Affiliates or any third
party selected by Dyax.  Dyax shall
reimburse ASD for its reasonable, documented out-of-pocket costs and expenses
incurred with in connection with providing such transition services; provided
that, in the event of a termination due to ASD’s breach, neither the existence
of this provision nor the fact of Dyax’s agreement to pay for such transition
services shall in any way effect or limit Dyax’s rights or remedies with
respect to such breach.

 

Termination of
this Agreement shall not relieve either party of obligations incurred prior to
termination.  The provisions of Sections
9.3, 9.4, 9.5, 13.3, 15.10 and 15.11 and Articles 10, 12 and 14, together with
and any other provisions which by their express terms extend beyond the
expiration or termination of this Agreement,
shall survive any termination of this Agreement.

 

13.4                           Termination of
Exclusivity.  In the event
that (i) Dyax has the right to terminate this Agreement for any reason (except
pursuant to Section 13.2(a) (Termination for Convenience), Dyax, on

 

19

 

immediate written notice to
ASD, may terminate Section 2.3(a), which shall have no further force or effect
from and after the delivery of such notice by Dyax.

 

14.                               Dispute
Resolution.

 

14.1                           Resolution by
Executives.  Any dispute,
controversy or claim initiated by either party arising out of, or resulting
from the breach or alleged breach by either party of its obligations under this
Agreement (other than bona fide third party actions or proceedings
filed or instituted in an action or proceeding by a third party against a party to this Agreement), whether before
or after termination of this Agreement, shall be in the first instance referred
to the respective chief executive officers of the parties unless such dispute
or claim must be filed to preserve a legal interest or injunctive relief is
required.

 

14.2                           Arbitration.  If chief executive officers (or their
representatives, it being agreed that the chief executive officer of either
party may designate a representative, provided such representative is empowered
with decision making in the dispute)  of
the parties fail to resolve any dispute as provided in Section 14.1 within
[*****], then such dispute shall be finally resolved by binding arbitration as
follows:

 

(a)                                  Any dispute that
might arise between the parties relating to or arising from this Agreement
shall be settled by binding arbitration in accordance with the then-prevailing
Commercial Arbitration Rules of the American Arbitration Association (“AAA”),
except where those rules conflict with this provision, in which case this
provision controls. Arbitration shall be conducted before a single arbitrator
selected from the AAA’s National Roster of Arbitrators, each of whom shall be a
lawyer with at least 15 years experience with a law firm or corporate law department
of over 25 lawyers or who was a judge of a court of general jurisdiction.  Each party shall have the right to meet and
interview the potential arbitrator for no more than one hour each prior to the
selection of an arbitrator.  The
arbitration shall be held, and Dyax and ASD irrevocably consent to arbitrate,
in New York, NY, unless they mutually agree upon an alternative location. The
arbitration shall be conducted in English. In rendering the award the
arbitrator must apply the substantive law of the State of Delaware (except
where that law conflicts with this clause); however, the interpretation and
enforcement of this arbitration provision shall be governed by the Federal
Arbitration Act.  The arbitrator shall
render a written opinion setting forth findings of fact and conclusions of law
with the reasons therefor stated.  Under
no circumstances shall the arbitrator award damages in excess of or
inconsistent with any limitations of liability contained in this
Agreement.  Any court with jurisdiction
shall enforce this clause and enter judgment on any award.  ASD and Dyax will agree upon, within [*****]
after the arbitrator is selected or, if they fail to agree, the AAA will
design, procedures that they will follow to assure that the arbitration will be
concluded and the award rendered within no more than eight months from
selection of the arbitrator.

 

(b)                                 The arbitration
proceedings shall be confidential, and neither party shall publicize the nature
of any dispute or the outcome of any mediation or arbitration proceedings
except to the extent required by law, provided in such case the party required
to make any disclosure informs the other party of such requirement to allow the
other party to seek a 

 

20

 

protective order.  The mediator or arbitrator, as the case may
be, shall issue appropriate protective orders to safeguard each party’s
confidential information.

 

(c)                                  Each party has
the right before or during the mediation or arbitration to seek and obtain from
the appropriate court provisional remedies such as attachment, an injunction,
replevin, etc., to avoid irreparable harm, maintain the status quo or preserve
the subject matter of the arbitration.

 

15.                               Miscellaneous.

 

15.1                           Relationship of
Parties.  ASD’s relationship with Dyax
hereunder shall be that of independent contractor, and neither party shall be
considered the agent of, partner of, employee or other member of the workforce
of, or participant in a joint venture with, the other party.  Neither party shall
have authority to bind the other party unless otherwise agreed to in writing by
such parties.

 

15.2                           Notices.  All notices, requests, demands and other
communications required or permitted to be given pursuant to this Agreement
shall be in writing and shall be deemed to have been duly given upon the date
of receipt if delivered by hand, recognized international overnight courier,
confirmed facsimile transmission, or registered or certified mail, return
receipt requested, postage prepaid to the following addresses or facsimile
numbers:

 

	
  If
  to Dyax:

  	
  Dyax
  Corp.

  
	
   

  	
  300
  Technology Square

  
	
   

  	
  Cambridge,
  MA 02139

  
	
   

  	
  [*****]

  
	
   

  	
   

  
	
  If
  to ASD:

  	
  AmerisourceBergen
  Specialty Group

  
	
   

  	
  3101
  Gaylord Parkway

  
	
   

  	
  Frisco,
  TX 75034

  
	
   

  	
  [*****]

  

 

Either
party may change its designated address, contact person and facsimile number by
notice to the other party in the manner provided in this Section.

 

15.3                           Assignment.  Neither party may assign its rights or
delegate its obligations under this Agreement without the prior written consent
of the other party, except that either party may assign this Agreement to any
of its Affiliates or to a successor in connection with the merger,
consolidation, or sale of all or substantially all of its assets or that
portion of its business pertaining to the subject matter of this Agreement,
with prompt written notice to the other party of any such assignment; provided
that: (i) if such assignee is an Affiliate, the assignor shall responsible for
and liable with respect to all assigned obligations and (ii) if such assignee
is not an Affiliate, (A) the assignee assumes the assignor’s obligations under
the Continuing Guaranty and Indemnification Agreement, and (B) the assignee has
net assets as of the end of its most recently completed fiscal year equal to or
in excess of the net assets of the assignor as of the end of its most recently
completed fiscal year, in each case as set forth in the audited balance sheet
of the assignor and assignee, and (iii) in the case of an assignment by Dyax,
the assignee is not a Competitor to ASD. 
For the purposes 

 

21

 

of this Section 15.3, a “Competitor” means any organization, entity or
person that competes with ASD including but not limited to the following
companies and their affiliated entities: [*****].  Notwithstanding the foregoing, ASD
acknowledges and agrees that Dyax may perform its obligations and exercise its
rights hereunder through a third party logistics provider.

 

15.4                           Force Majeure. Each party’s
obligation under this Agreement will be excused to the extent any delay or
nonperformance is caused by strikes or other labor disturbance, acts of God,
war, or other conditions beyond the reasonable control of that party, but only
during the duration of such condition.

 

15.5                           Amendment and
Waiver.  This Agreement may be amended,
supplemented, or otherwise modified only by means of a written instrument
signed by both parties.  Any waiver of
any rights or failure to act in a specific instance shall relate only to such
instance and shall not be construed as an agreement to waive any rights or fail
to act in any other instance, whether or not similar.  To be valid, any waiver must be in writing.

 

15.6                           Severability.  In the event any provision of this Agreement
should be held invalid, illegal or unenforceable, the remaining provisions
shall not be affected or impaired and the parties shall use all reasonable
efforts to replace the applicable provision with a valid, legal and enforceable
provision which insofar as practical implements the original intent of such
invalid, illegal or unenforceable provision, provided, however, that if the
parties fail to reach such agreement within sixty (60) days, a party whose
rights or obligations are materially adversely affected as a result of a
provision being held invalid, illegal or unenforceable may terminate this
Agreement.

 

15.7                           Headings.  All headings used in this Agreement are
inserted for convenience only and are not intended to affect the meaning or
interpretation of this Agreement or any Article or Section hereof.

 

15.8                           Successors and
Assigns.  This Agreement shall be binding
on and shall benefit any and all successors, trustees, permitted assigns and
other successors in interest of the parties.

 

15.9                           Applicable Law;
Disclaimer of Puerto Rico Law 75.

 

(a)                                  This Agreement
shall be construed and enforced in accordance with the laws of the State of
Delaware (excluding the choice of law provisions thereof).

 

(b)                                 The parties
expressly disclaim, to the fullest extent allowed by Applicable Law, any
application of the Puerto Rico Dealers Act, Law No. 75 of June 1964 (the “Dealers
Act”) as amended, and the parties acknowledge that the Dealers Act shall not
apply in the interpretation or enforcement of any of the rights and obligations
of the parties hereto.

 

15.10                     Contract
Interpretation.  The parties
have jointly negotiated this Agreement and, thus, neither this Agreement nor
any provision will be interpreted for or against any party on the basis that it
or its attorney drafted the Agreement or the provision at issue.   When
this Agreement requires approval of one or more parties, such approval may not
be unreasonably withheld or delayed.  Words, regardless of the number and gender
specifically used, will be construed to include any other number, singular or
plural, and any gender, masculine, feminine, or neuter, as the context 

 

22

 

requires.  “And” includes “or.”  “Or” is disjunctive but not necessarily
exclusive.  “Including” means “including
but not limited to.” Unless other specifically stated, the term “days” means
calendar days.

 

15.11                     Entire
Agreement; No Reliance.  Each
of the parties agrees and acknowledges that this Agreement, including the
Continuing Guaranty and the attachments referred to herein, (i) constitutes the
entire agreement and supersedes all prior and contemporaneous agreements,
understandings, negotiations and discussions, whether oral or written, between
the parties with respect to the subject matter of this Agreement, and (ii) is
not intended to confer any rights or remedies, or impose any obligations, on
any person other than the parties hereto. 
Each of the parties expressly agrees and acknowledges that, other than
those statements expressly set forth in this Agreement, it is not relying on
any statement, whether oral or written, of any person or entity with respect to
its entry into this Agreement or to the consummation of the transactions
contemplated by this Agreement.

 

15.12                     Counterparts.  This Agreement may be executed in multiple
counterparts, each of which shall be deemed an original but all of which
together shall constitute one and the same instrument.  Facsimile execution and delivery of this
Agreement are legal, valid and binding execution and delivery for all purposes.

 

[signature page to follow]

 

23

 

IN WITNESS WHEREOF, the parties hereto have caused
this Agreement to be executed by their duly authorized respective officers as
of the Effective Date.

 

 

	
  ASD Specialty
  Healthcare, Inc.

  	
   

  	
  Dyax Corp.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Chris B. Myers

  	
   

  	
  By:

  	
  /s/ Ivana Magovcevic-Liesbisch

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Name:

  	
  Chris B. Myers

  	
   

  	
  Name:

  	
  Ivana Magovcevic-Liesbisch

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
  COO

  	
   

  	
  Title:

  	
  Executive Vice President Corporate

  Development and General Counsel

  

 

 

AmerisourceBergen
Specialty Group, Inc., a Delaware corporation, agrees that is shall be
financially responsible for any unsatisfied liabilities of ASD Specialty
Healthcare, Inc. under this Agreement, provided that any defense or privilege
that may be asserted by ASD Specialty Healthcare, Inc. may also be asserted by
AmerisourceBergen Specialty Group, Inc.

 

 

	
   

  	
  AmerisourceBergen Specialty Group, Inc.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  By:

  	
  /s/ Mike Mullen

  
	
   

  	
   

  	
   

  
	
   

  	
  Name:

  	
  Mike Mullen

  
	
   

  	
   

  	
   

  
	
   

  	
  Title:

  	
  President

  

 

24

 

LIST
OF EXHIBITS

 

EXHIBIT
A — Product Description

EXHIBIT
B — Service Level Commitments

EXHIBIT
C — Chargeback Policies

EXHIBIT
D — Consignment

EXHIBIT
E — Product Returns Policy

EXHIBIT
F — Continuing Guaranty

 

25

 

EXHIBIT A

Product Description

 

	
  Product Trade Name:

  	
   

  	
  Kalbitor®

  
	
  Generic Name:

  	
   

  	
  ecallantide

  
	
  NDC Number:

  	
   

  	
  47783-101-01

  

 

Kalbitor
is a recombinant protein with high affinity and high specificity for human
plasma kallikrein and is used in the treatment of Hereditary Angioedema (HAE).

 

Kalbitor
is temperature sensitive and must be stored and shipped at 2-8°C (36-42°F).

 

Kalbitor
is packaged in a single carton containing three 1 mL vials and is administered
through three subcutaneous injections.

 

26

 

EXHIBIT B

Service Level Commitments

 

[*****]

 

27

 

EXHIBIT C

Chargeback Policies

 

[*****]

 

28

 

EXHIBIT D

Consignment

 

[*****]

 

29

 

EXHIBIT E

Product Returns Policy

 

[*****]

 

30

 

EXHIBIT F

Continuing Guaranty

 

[attached hereto]

 

31

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