SECOND AMENDMENT TO DISTRIBUTION AGREEMENT (Tyvaso)

whether the information is received during a weekend or public holiday.

(iii.)       “Product Complaint” or “PC” shall mean any written, electronic, or oral communication that alleges deficiencies of the identity, quality, durability, reliability, safety, effectiveness, or performance of UT Product.

(iv.) Additional terms used but not defined in this Section 9.3 and Attachment G shall have the meanings as described to them in the Code of Federal Regulations, Section 314.80, Postmarketing reporting of adverse drug experiences.

(b)               UT has responsibility for all post-market pharmacovigilance and safety regulatory reporting for UT Product in the Territory, including all reporting obligations to the applicable regulatory authorities, and shall comply with all Applicable Laws in carrying out those activities.

(c)                DISTRIBUTOR agrees to have and maintain suitable pharmacovigilance policies, procedures, systems, and resources (including staff training on the definitions and timelines provided in Attachment G) to ensure compliance with all Applicable Law in the Territory, including maintaining adequate written procedures to address the receipt, evaluation, and reporting of Postmarketing Adverse Drug Experience (PADE) activities that are being performed under this Agreement.

(d)               DISTRIBUTOR shall identify and notify UT of any potential ADR and/or PC in accordance with Attachment G.  Either Party may update its contact information for purposes of Attachment G from time to time by providing written notice to the other Party.

e.                                       Section 9.5 is hereby deleted in its entirety and replaced with the following:

9.5                               Visits by Parties.  DISTRIBUTOR shall permit UT to visit its place of business and inspect its facilities, systems, records, inventories and other relevant materials and records relating solely to its performance under this Agreement, at DISTRIBUTOR’s expense. Such inspections may be made no more than once each calendar year, at reasonable times during normal business hours and on not less than upon thirty (30) business days’ notice, accompanied by a detailed scope.  UT shall have the right to conduct additional “for cause” audits as needed to address specific quality problems and/or if issues arise that need inspection to ensure DISTRIBUTOR’s compliance with and ability to comply with the terms of this Agreement. “For cause” audits may be performed with less than thirty (30) days’ notice, but with as much notice is as reasonably practicable taking into account the level of urgency associated with a “for cause” audit.  If a designated agent of UT conducts the audit, the designated agent shall enter into a confidentiality agreement with Accredo. Audits during the months of December and January are limited to regulatory needs.

UT may choose to share a confidential audit report summarizing all audit observations with DISTRIBUTOR.  DISTRIBUTOR will issue responses to all observations in writing to UT’s Quality Assurance unit within 30 calendar days of receipt.

UT will evaluate the acceptability of the audit observation responses (as acceptable, incomplete response, inadequate response and/or other).  Both

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parties shall bring to resolution any audit response deemed unacceptable by UT.  DISTRIBUTOR will incorporate in its commitment tracking system any corrective actions and related timelines committed to by DISTRIBUTOR.

f.                                        Attachment G to this Amendment is hereby added to the Agreement as Attachment G.

g.                                      Section 12.1 is hereby deleted in its entirety and replaced with the following:

12.1        Insurance Requirements.

(a)                                 Distributor Insurance.  DISTRIBUTOR shall maintain in effect during the term of this Agreement a comprehensive general liability policy (which may be in the form of primary or excess coverage) in an amount not less than Two Million Dollars ($2,000,000) per occurrence and Three Million Dollars ($3,000,000) in the aggregate. DISTRIBUTOR shall provide thirty (30) days’ written notice to UT in the event of any modifications, cancellations or terminations thereof. If such policies are written on a claims made policy form, DISTRIBUTOR shall maintain coverage for claims arising out of this agreement for a period of at least Five (5) years following termination of this agreement or any renewal thereof or any renewal thereof.  DISTRIBUTOR agrees to provide UT with a certificate of insurance evidencing compliance with this section within ten (10) days of execution of this Agreement and prior to the policy’s renewal date each year thereafter.

(b)                                 UT Insurance. UT shall maintain in effect during the term of this Agreement a comprehensive general liability policy (which may be in the form of primary or excess coverage) in an amount not less than Two Million Dollars ($2,000,000) per occurrence and Three Million Dollars ($3,000,000) in the aggregate and a product liability policy (which may be in the form of primary or excess coverage) in an amount not less than Ten Million Dollars ($10,000,000) per occurrence and in the aggregate.  These policies shall provide for thirty (30) days’ written notice to UT in the event of any modifications, cancellations or terminations thereof.  If such policies are written on a claims made policy form, UT shall maintain coverage for claims arising out of this agreement for a period of at least Five (5) years following termination of this agreement or any renewal thereof. DISTRIBUTOR agrees to provide UT with a certificate of insurance evidencing compliance with this section within ten (10) days of execution of this Agreement and prior to the policy’s renewal date each year thereafter.

h.                                      Section 18.6 is hereby deleted in its entirety and replaced with the following:

18.6                        Notices; Language.  Except as may be otherwise provided in this Agreement, any notice, demand or request given, made or required to be made shall be in writing and shall be effective, unless otherwise provided herein, either (a) when delivered in person to the other Party, or (b) on the same business day that it is transmitted by facsimile to the facsimile number (s) set forth below, with electronic confirmation of receipt, if transmitted prior to 5:00 p.m. Eastern time on such business day, or on the first business day following such transmission if transmitted after 5:00 p.m. Eastern Time or if transmitted on a day other than a business day; provided a hard copy is deposited within one (1) day after such transmissions in the U.S. mail, postage prepaid, and addressed as set forth below for notices by U.S. mail; or (c) on the third business day following its deposit in the U.S. mail, postage and addressed as follows:

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i.                                         Attachment E, Designated Shipment Locations and Designated Storage Locations, is hereby deleted in its entirety and replaced with the revised Attachment E, Designated Shipment Locations and Designated Storage Locations, attached hereto.

4.              Except as specifically set forth herein, all other provisions of the Accredo Agreement shall continue unchanged.

(Signature Page to Follow)

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IN WITNESS WHEREOF, the parties hereto have caused this Second Amendment to be executed as of the Second Amendment Effective Date set forth above by their duly authorized representatives.

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ATTACHMENT E

DESIGNATED SHIPMENT LOCATIONS AND DESIGNATED STORAGE LOCATIONS

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Attachment G

1.                   Timelines for delivery of reports from DISTRIBUTOR to UT (Post Marketing)

*After DISTRIBUTOR acknowledgement of delays in ADR/PC reporting, DISTRIBUTOR will notify UT within 1 business day. .

2.                   Contact information for the parties to this Agreement

3.                   Reference:

·                            Food and Drug Administration - Code of Federal Regulations, TITLE 21 CHAPTER I - SUBCHAPTER D -PART 314 -Subpart B Sec. 314.80 Postmarketing reporting of adverse drug experiences

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