A.

WHEREAS, UT has developed triprostenol, a pharmaceutical product for the treatment of pulmonary hypertension to be marketed worldwide under the brand name UNIPROST ^TM (the “UT Product”);

B.

WHEREAS, UT has entered into an agreement with MiniMed, Inc., a Delaware corporation, pursuant to which UT will purchase from MiniMed, Inc. infusion pumps and consumable products, supplies or other goods which are used in connection with infusion pumps for the delivery of UNIPROST ^TM , which supplies include, without limitation infusion sets with catheters and medication reservoirs (the “MiniMed Product”);

C.

WHEREAS, DISTRIBUTOR has represented that it possesses the necessary expertise, financial resources and marketing organization to promote and sell the UT Product and the MiniMed Product (together, the UT Product and the MiniMed Product shall be referred to herein as the “Products”) and desires to acquire from UT the right to sell, market, distribute and maintain the Products in the Territory (as hereinafter defined);

D.

WHEREAS, UT is willing to appoint DISTRIBUTOR and DISTRIBUTOR is willing to accept appointment, as a distributor of the Products in the Territory; and

E.

WHEREAS, the parties hereto believe that the business relationship regarding the Products and related support will be of mutual advantage.

1.1

Defined Terms .  The following terms, when used in capitalized form in this Agreement, shall have the meanings set forth below:

(a)

“Agreement” shall mean this Distribution Agreement entered into by and between UT and DISTRIBUTOR as of the Effective Date.

(b)

“Affiliate” when used with reference to either Party shall mean any corporation controlling, controlled by or under common control with the said Party and any officer, director or employee of such corporation, as the case may be.  For purposes hereof, “control” shall mean ownership, directly or indirectly, of more than fifty percent (50%) of the securities having the right to vote for the election of directors, in the case of a corporation, and more than fifty percent (50%) of the beneficial interest in the capital, in the case of a business entity other than a corporation.

(c)

“Best Efforts” shall mean those efforts that would be made by a reasonably prudent business person acting in good faith and in the exercise of reasonable commercial judgment.

(d)

“Clinical Trial Patients” shall mean Included Patients who are enrolled in clinical trials relating to UT Product prior to Commercial Launch.

(e)

“Commercial Launch” shall mean the date on which UT first makes all Products available for commercial sale, after the receipt of all applicable government and regulatory approvals required to be obtained by UT or its suppliers prior to commercial sale of the Products.

(f)

“Confidential Information” shall mean all information disclosed by either party (“disclosing party”) to the other party (“receiving party”), regardless of the form in which it is disclosed, including information relating to the disclosing party’s markets, product specific payer policies, databases, customers, products, patents, inventions, procedures, methods, designs, strategies, plans, assets, liabilities, prices, costs, revenues, profits, organization, employees, agents, resellers or business in general, and with respect to UT as disclosing party, information embodied in the Products.  The following shall not be considered Confidential Information:

(i)

Information which is or becomes in the public domain through no fault or act of the receiving party;

(ii)

Information which was independently developed by the receiving party without the use of or reliance on Confidential Information;

(iii)

Information which was provided to the receiving party by a third party under no duty of confidentiality to the disclosing party; or

(iv)

Information which is required to be disclosed by law, rule, regulation or governmental agency, provided, however, prompt prior notice thereof shall be given to the disclosing party.

(g)

“Effective Date” shall mean the date first above written.

(h)

“Force Majeure” shall mean any event, not existing as of the Effective Date and not reasonably within the control of the Parties as of such date, which, in whole or in material part, prevents or makes commercially unreasonable one Party’s performance of its obligations under this Agreement.  Force Majeure shall include, without limitation: fire, storm, earthquake, flood, acts of State or other governmental action, war or civil unrest, labor dispute, inability to obtain labor or materials, and prolonged shortage of energy or any other supplies.

(i)

“Included Patients” shall mean those individuals diagnosed with pulmonary hypertension (or any other condition which shall have been approved by the United States Food and Drug Administration as an approved indication for UT Product), and whom DISTRIBUTOR shall have accepted (at its sole discretion) on to its service as its patient.

(j)

“NCIP Patient” (Non-collecting Included Patient) shall mean any Included Patient who has no source of third party payment or reimbursement either for UT Product or for MiniMed Product and who is not a Patient Assistance Program Patient, and who fails to pay for Products at DISTRIBUTOR’s usual and customary charge for Products after DISTRIBUTOR uses its customary Best Efforts to collect such payment from such patient for at least a 90 day period.

(k)

“PAP Patient” (Patient Assistance Program Patient) shall mean any Included Patient who is enrolled in the Patient Assistance Program as established by UT from time to time.  The currently anticipated criteria for this program are described on Attachment C.

(1)

“Price” shall mean the respective price for the respective Product as set forth on Attachment A hereto, subject to the terms and conditions reflected on Attachment A.

(m)

“MiniMed Product” shall mean infusion pumps and consumable products, supplies or other goods developed by MiniMed, Inc. which are medically necessary and used in connection with infusion pumps for the delivery of UNIPROST ^TM , which supplies include, without limitation infusion sets with catheters and medication reservoirs.

(n)

“UT Trademark” shall mean any of the UT trademarks, logotypes and trade names listed on Attachment B hereto, as such Attachment may be modified from time to time by UT and communicated in writing by UT to DISTRIBUTOR during the term of this Agreement.

(o)

“Party” shall mean either of the two parties to this Agreement.

(p)

“Products” shall mean both the UT Product and the MiniMed Product.

(q)

“Territory” shall mean the fifty states, territories and possessions of the United States only, unless otherwise expressly agreed in writing by the Parties.

(r)

“UT Product” shall mean triprostenol, a pharmaceutical product for the treatment of pulmonary hypertension to be marketed in the Territory under the brand name UNIPROST ^TM .

1.2

Other Rules of Interpretation .  Unless the context clearly indicates otherwise, the following rules shall govern the interpretation of this Agreement:

(a)

The definitions of all terms defined herein shall apply equally to the singular, plural, and possessive forms of such terms;

(b)

All references herein to “days” shall mean calendar days; and

(c)

All references to “Sections” shall mean the corresponding Sections of this Agreement.

2.1

Authority .  Each Party represents and warrants that it possesses all corporate power and authority necessary to enter into this Agreement and to perform its obligations under this Agreement.  All corporate acts and other proceedings required to be taken by or on the part of each Party to authorize it to perform its obligations under this Agreement have been duly and properly taken.  This Agreement has been duly executed and delivered by each Party and constitutes legal, valid and binding obligations of each Party enforceable in accordance with its terms, subject to the application of general principles of equity.

2.2

No Conflicts .  Each Party represents and warrants that the execution and performance of this Agreement by each Party will not conflict with or violate any other agreement or obligation binding on it.

2.3

Approvals .  Except as expressly provided herein, each Party represents and warrants that no approval, authorization, consent or other order or action of or filing with any court, administrative agency or other governmental authority is required for the execution and delivery by such Party of this Agreement or its consummation of the transactions contemplated by this Agreement.

2.4

Debarment Certification Requirements .  Each Party certifies that it has not been debarred under the provisions of the Generic Drug Enforcement Act of 1992, 21 U.S.C. § 335(a) and (b).  In the event that during the term of this Agreement, either Party (i) becomes debarred or (ii) receives notice of an action or threat of an

action with respect to its debarment, such Party shall notify the other Party immediately.  Each Party hereby certifies that it has not and will not use in any capacity the services of any individual, corporation, partnership or association which has been debarred under 21 U.S.C. § 335(a) and (b).  In the event that either Party becomes aware of the debarment or threatened debarment of any individual, corporation, partnership or association providing services to the other Party which directly or indirectly relate to activities under this Agreement, the other Party shall be immediately notified.

3.1

Scope; Non-exclusive .  UT hereby appoints DISTRIBUTOR, and DISTRIBUTOR hereby accepts such appointment, as a distributor of the Products during the term of this Agreement, subject to the terms and conditions of this Agreement.  This appointment is non-exclusive, and UT reserves the right to appoint additional distributors in the Territory and to distribute the Products in the Territory itself.

3.2

Subdistributors .  DISTRIBUTOR shall not, without the prior written approval of UT, appoint any distributors or agents to act on behalf of DISTRIBUTOR (collectively, “Subdistributors”) to promote and/or distribute the Products within the Territory, other than any of its Affiliates.  DISTRIBUTOR shall at all times remain fully liable for the performance of any approved subdistributors and DISTRIBUTOR shall provide UT with a written acknowledgement executed by each Subdistributor that it has read this Agreement and agrees to be bound by its terms and conditions, including those contained in the attachments hereto.

3.3

Sales Outside the Territory .  DISTRIBUTOR shall not distribute, sell or otherwise provide the Products outside of the Territory and shall not advertise, promote or solicit customers for the Products outside the Territory.

4.1

Distribution Promotion .  DISTRIBUTOR shall use its Best Efforts to fund and support ongoing promotion of its distribution of the Products, consistent with DISTRIBUTOR’s normal funding and support for its overall distribution activities; provided, however, UT shall approve in advance any marketing material used by DISTRIBUTOR other than the UT marketing material provided by UT to DISTRIBUTOR pursuant to Section 5.3.  Such Best Efforts shall include, but not be limited to:

(a)

Maintaining throughout the Territory adequate marketing, sales and order-fulfillment staffs who are adequately trained. The Parties acknowledge that this obligation requires DISTRIBUTOR to have the capability to provide the foregoing services throughout the Territory, but does not require DISTRIBUTOR to have a physical office within each jurisdiction within the Territory;

(b)

Promptly responding to all inquiries from customers, including responding to complaints, processing all orders and effecting all shipments of the Products for Included Patients;

(c)

Providing the Products to Included Patients following discharge from hospitals upon receipt of written notice from the hospital and pursuant to physician orders;

(d)

Attending and exhibiting at appropriate trade shows involving patients and/or physicians specialties that have a high propensity or likelihood to diagnose and treat patients suffering from pulmonary hypertension. DISTRIBUTOR will develop in conjunction with UT, sales sheets which detail the available therapy and support services from DISTRIBUTOR for patients on Product. At a minimum, DISTRIBUTOR will attend the following trade shows or national conferences of the following organizations:

(i)

Pulmonary Hypertension Association;

(ii)

American Heart Association;

(iii)

American Lung Association;

(iv)

American Thoracic Association;

(v)

American College of Cardiology;

(vi)

American Rheumatology Association;

(vii)

Scleroderma Foundation; and

(e)

Diligently investigating and pursuing all leads and inquiries of potential customers referred to DISTRIBUTOR by UT and to report promptly on the status of such leads and inquiries. Notwithstanding the foregoing, nothing in this Agreement shall be construed as requiring DISTRIBUTOR to admit to its service, or provide Products to, any particular individual(s) or types of individual(s). The determination of which individuals shall become Included Patients is in DISTRIBUTOR’s sole discretion.

4.2

Appropriate Products . Notwithstanding anything in this Agreement or attachments hereto to the contrary, DISTRIBUTOR’s obligations to provide MiniMed Product with UT Product shall be subject to (i) patient choice and physician and payor preference provided, however, that any pumps and supplies other than the MiniMed Products are considered therapeutically equivalent substitutes in accordance with prevailing medical judgment, and (ii) UT’s ability to supply MiniMed Product. DISTRIBUTOR will not promote the use or sale of any pump and supplies other than the MiniMed Product. In addition, DISTRIBUTOR shall not be obligated to provide MiniMed Product with UT Product to the extent that DISTRIBUTOR determines in its sole commercially reasonable discretion that it has received a significant number of significant patient, physician or payor complaints regarding the MiniMed Product and DISTRIBUTOR shall provide prompt notice to UT upon such determination.

4.3

Policies and Procedures . DISTRIBUTOR shall comply with UT’s DISTRIBUTOR Policies and Procedures, including, but not limited to, third party payer policies and procedures and policies and procedures relating to the MiniMed Product, a copy of which is attached hereto as Attachment E. UT reserves the right to change such Policies and Procedures upon notice to DISTRIBUTOR, provided however, that to the extent that any such change shall impose any greater restrictions or costs on DISTRIBUTOR, DISTRIBUTOR’s prior consent to such changes shall be required, such consent not to be unreasonably withheld or delayed.

4.4

Written Assurance . DISTRIBUTOR hereby assures UT that DISTRIBUTOR shall not export the Products from the Territory to any destination to which re-export requires a license under the United States Export Administration Regulations unless and until DISTRIBUTOR shall have applied for and obtained, at the request and expense of DISTRIBUTOR, a license from the Office of Export Administration, United States Department of Commerce for such report.

4.5

Alteration of Products . DISTRIBUTOR shall not alter the Products except with prior written consent of UT.

4.6

Product Claims . DISTRIBUTOR shall make no claims concerning the Products except as authorized by UT in writing or as are contained in UT’s marketing materials provided to DISTRIBUTOR for use in the Territory.

4.7

Complaints . DISTRIBUTOR shall promptly submit to UT’s Vice President of Operations or MiniMed, Inc.’s Technical Service Department detailed information regarding complaints from customers in the Territory, including complaints of defective or substandard UT Products or MiniMed Products, respectively.

4.8

Inventory . DISTRIBUTOR will maintain an inventory adequate to fill two (2) months of anticipated orders of the UT Products, with the intention of maintaining sufficient inventory to ensure availability;

4.9

Temperature Protection . DISTRIBUTOR shall ensure that during the entire time the Products are under DISTRIBUTOR’s control, that the Products are stored at the temperature specified by UT and/or MiniMed, Inc. for such Product.

4.10

Distributor Expenses . DISTRIBUTOR shall bear all of its own costs and expenses incurred in carrying out its obligations under this Agreement, including, but not limited to, all rents, salaries, commissions, demonstration, travel and accommodation.

5.1

Training . UT will provide training to DISTRIBUTOR for Products at a time to be mutually agreed upon by the parties, but no less frequently than semi-annually. The duration, content and location of such training shall be as agreed upon by the

parties. DISTRIBUTOR shall bear all costs of travel and living expenses for its personnel to attend such training. If training is provided at DISTRIBUTOR’s location, DISTRIBUTOR shall provide appropriate facilities, without expense to UT. UT shall bear all costs relating to its personnel and their travel and living expenses, materials and facilities utilized for training, together with any other related costs it incurs.

5.2

Samples . UT will provide a reasonable quantity of sample Products to DISTRIBUTOR for the sole purpose of marketing the Products to prospective customers in the Territory, subject to applicable legal requirements. All sample Products remain the property of UT and DISTRIBUTOR shall promptly return all samples to UT upon request. Samples shall be labeled clearly by UT as “SAMPLES-NOT FOR RESALE/NOT FOR PATIENT CONSUMPTION”.

5.3

Sales Material . UT will provide to DISTRIBUTOR reasonable quantities of such sales materials, reprints, brochures, package inserts, peer review articles and other scientific and medical information regarding the Products, informational material and other marketing literature for use by DISTRIBUTOR and its sales force when marketing the Products.

5.4

Marketing Support . UT will provide DISTRIBUTOR with such marketing support as the parties may mutually agree.

5.5

UT Expenses . UT shall bear all of its own costs and expenses incurred in carrying out its obligations under this Agreement, including but not limited to, all rents, salaries, commissions, advertising, demonstration, travel and accommodation.

6.1

Purchase Orders . DISTRIBUTOR shall submit written purchase orders for Products to UT by mail, courier delivery or facsimile. Each such order shall set forth (a) the Products ordered, including item numbers; (b) quantities of each; (c) requested delivery dates; and (d) any specific shipping instructions. Except as otherwise agreed by UT, DISTRIBUTOR shall submit such purchase orders at least sixty (60) days prior to the requested delivery dates.

6.2

Acceptance of Orders . All DISTRIBUTOR purchase orders are subject to acceptance in writing by UT, which acceptance shall be delivered by mail, courier or facsimile, or deemed to have occurred if DISTRIBUTOR shall not have received an acceptance or rejection of the order within five business days of UT’s receipt of the order. Each purchase order shall be deemed to be an offer by DISTRIBUTOR to purchase the Products pursuant to the terms of this Agreement and, if and when accepted by UT as hereinabove provided, shall give rise to a contract between DISTRIBUTOR and UT on the terms and conditions set forth herein to the exclusion of any additional or contrary terms set forth in the DISTRIBUTOR purchase order or which otherwise conflicts with this

Agreement. UT shall use its Best Efforts, consistent with the other requirements of its business as determined by UT, to accept all purchase orders placed by DISTRIBUTOR in accordance with the terms and conditions of this Agreement.

6.3

Delivery Terms . Unless otherwise agreed to in writing by UT and DISTRIBUTOR, all deliveries of the Products shall be F.O.B. DISTRIBUTOR’s facility. UT shall insure each shipment of such Products with a reputable insurer for the full invoice price of each shipment. Risk of loss and title to the Products shall pass upon delivery to DISTRIBUTOR at its facility.

6.4

Modification of Orders . No accepted purchase order shall be modified or canceled except upon the written agreement of both parties.

6.5

Change Order Charges . If DISTRIBUTOR requests modifications in an accepted order prior to the scheduled delivery date provided in such order, in consideration for accepting such change order, UT may require DISTRIBUTOR to extend the scheduled delivery date and/or to pay a change order charge equal to the sum of the actual documented non-recoverable costs incurred by UT by reason of such change order.

6.6

Product Changes . Subject to applicable regulatory approval, UT reserves the right, in its sole discretion and without incurring any liability to DISTRIBUTOR except as otherwise provided in this Agreement, to (a) alter any Product; (b) discontinue the manufacture of any Product; or (c) commence the manufacture and sale of new products having features which make any Product wholly or partially obsolete, provided however, that if such new Product may be used as a substitute for Product, UT shall negotiate in good faith with DISTRIBUTOR to reach an agreement on terms whereby DISTRIBUTOR may purchase such new products. Notwithstanding the foregoing, UT shall use its Best Efforts to provide DISTRIBUTOR with at least sixty (60) days prior written notice of any such change. UT also reserves the right, in its sole discretion and without incurring any liability to DISTRIBUTOR except as otherwise provided in this Agreement, immediately to alter the specifications or the manufacturing process for any Product for reasons of health or safety. UT shall fill all accepted purchase orders from DISTRIBUTOR for any altered or discontinued Products for which manufacturing and commercial deliveries have commenced prior to the effective date of such a change but otherwise shall have no obligation to do so unless the delivery date requested in the relevant purchase order was prior to the effective date of such a change.

6.7

Rolling Forecasts . DISTRIBUTOR and UT shall mutually develop and agree upon a non-binding twelve (12) month forecast indicating DISTRIBUTOR’ s intended purchases of Products, as well as such other information as UT may reasonably request. Such forecasts shall be updated by DISTRIBUTOR on a rolling basis each calendar quarter, and each updated forecast must be received by UT no later than thirty (30) days after the end of each calendar quarter.

7.1

Prices . DISTRIBUTOR shall pay the Prices for the Products purchased under this Agreement which are in effect at the time of acceptance of the relevant purchase order submitted by DISTRIBUTOR, except as provided in Section 7.2. All costs relating to shipping, insuring, packing, handling and delivering the Products to DISTRIBUTOR’S facility shall be at the sole expense of UT.

7.2

Price Changes . At any time during the term of this Agreement, UT may increase its Prices for the Products upon at least sixty (60) days prior written notice to DISTRIBUTOR, but only as long as the respective Price for Product is at all times at least [***] percent ([***]%) less than the then current published “Average Wholesale Price” (AWP) for the respective Product. Increased prices shall not apply to purchase orders accepted prior to the effective date of the price increase unless such orders provide for delivery, and delivery is in fact made, more than ninety (90) days after the date of acceptance of the order. Price decreases with respect to all Products shall be effective immediately upon written notice to DISTRIBUTOR on all such Products not yet delivered. UT agrees that it will not sell the Products during the term of this Agreement to another distributor in the Territory at a price (including payment terms) lower than what it is charging DISTRIBUTOR.

7.3

Payment Terms; Invoices . DISTRIBUTOR shall make payments for the Products within 60 days of its receipt of the respective invoice. Terms of purchase shall be two percent (2%) prompt pay discount if paid within thirty (30) days of invoice receipt. UT shall ensure that all invoices for Products accurately reflect the actual charge to DISTRIBUTOR for the Products, including to the extent applicable any and all discounts, free goods or other reductions in price of the Products to DISTRIBUTOR. All payments shall be made in United States Dollars.

7.4

Overdue Payments . If and for so long as any payment from DISTRIBUTOR to UT under this Agreement shall be overdue:

(a)

Interest in the applicable currency of payment shall be due and payable at the rate of interest of twelve percent (12%) per annum, or such lower rate as may be the maximum legally permissible rate of interest, on all balances outstanding from the first date such payment is due until fully paid; and

(b)

UT shall have the right to recover its collection costs and expenses (including reasonable attorneys’ fees) for late payments. UT reserves the right to revoke any credit terms it may offer DISTRIBUTOR if there is any unsettled or outstanding balance owed by DISTRIBUTOR to UT.

7.5

Tax Payments . Each Party shall pay all taxes, duties, import deposits, assessments and other governmental charges, however designated, that are now or

hereafter imposed upon such Party by any governmental authority or agency in connection with the performance of its obligations under this Agreement.

7.6

Resale Prices .  DISTRIBUTOR may offer the Products in the Territory at such prices or discounts as DISTRIBUTOR, in its sole discretion, may determine.

8.1

Acceptance of Products .  DISTRIBUTOR shall promptly inspect each shipment of the Products.  In the event of any shortage, damage, expiration or discrepancy in a shipment of Products which is patently obvious, DISTRIBUTOR shall promptly report the same to UT and furnish such written evidence or other documentation as UT may reasonably request.  DISTRIBUTOR shall be deemed to have accepted a shipment and UT shall not be liable for any such shortage, damage, expiration or discrepancy in such shipment unless DISTRIBUTOR provides UT with such notice and substantiating evidence within forty-five (45) days of arrival of the Products at DISTRIBUTOR’s shipping address in the Territory.  Upon receipt of the reasonable substantiating evidence of such shortage, damage or discrepancy, UT shall refund any payments made for the Product or UT shall promptly provide additional or substitute Products to DISTRIBUTOR, and UT shall promptly reimburse (or, at DISTRIBUTOR’s option, DISTRIBUTOR may deduct such amounts from payments due to UT hereunder) for any actual costs, expenses or damages incurred by DISTRIBUTOR, directly or indirectly, as a result of such shortage, damage or discrepancy in or to a shipment.

8.2

Product Warranty .  UT hereby authorizes DISTRIBUTOR to pass on the UT standard warranty and the MiniMed, Inc. standard warranty each set forth in Attachment D for the UT Product and MiniMed Product, respectively, to DISTRIBUTOR’s customers in the Territory, which may be revised by UT upon notice to DISTRIBUTOR.  DISTRIBUTOR shall not offer its customers any warranties different from or in addition to those given by UT hereunder.

8.3

Excluded Claims .  UT shall not have any additional warranty obligations to DISTRIBUTOR or DISTRIBUTOR’s customers under Section 8.2 above or otherwise to the extent that DISTRIBUTOR has made any warranties, oral or written, beyond those expressly set forth in the standard UT warranty, Attachment D hereto.

8.4

Limited Warranty .  THE WARRANTIES SET FORTH IN THE UT WARRANTY, ATTACHMENT D HERETO, AND THE OTHER TERMS AND CONDITIONS OF THIS AGREEMENT, ARE IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, WHICH ARE HEREBY DISCLAIMED AND EXCLUDED BY UT, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR USE.  THE SOLE AND EXCLUSIVE REMEDIES FOR BREACH OF UT’S STANDARD WARRANTIES SHALL

BE LIMITED TO THE REMEDIES PROVIDED IN UT’S STANDARD WARRANTIES SET FORTH ON ATTACHMENT D, ATTACHED HERETO, AND AS OTHERWISE PROVIDED IN THIS AGREEMENT.

8.5

Limited Remedy .  UT SHALL NOT BE LIABLE TO DISTRIBUTOR OR ANY OF THEIR CUSTOMERS FOR LOSS OR DAMAGE CAUSED BY DELAY IN FURNISHING THE PRODUCTS UNDER THIS AGREEMENT.  UT SHALL NOT BE LIABLE TO DISTRIBUTOR OR ANY THIRD PARTY FOR ANY SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL LOSSES OR DAMAGES, EVEN IF UT SHALL HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH POTENTIAL LOSS OR DAMAGE BY DISTRIBUTOR OR ANY THIRD PARTY.  IN NO EVENT, SHALL UT BE LIABLE FOR ANY DAMAGES IN EXCESS OF THE LESSER OF THE COST OF REPLACEMENT OR REFUND OF THE NET PURCHASE PRICE PAID BY DISTRIBUTOR FOR ANY DEFECTIVE OR DAMAGED PRODUCT.  NOTWITHSTANDING THE FOREGOING, IN CASE OF ANY CONFLICT BETWEEN THE PROVISIONS OF THIS SECTION AND SECTION 12.3, SECTION 12.3 SHALL CONTROL.

9.1

FDA Approval .  UT represents and warrants that as of the Effective Date with respect to clinical trials, and prior to Commercial Launch with respect to commercial sale, the Products have received or shall have received, as the case may be, (a) clearance from the FDA to in the Territory for the approved indications, and (b) all federal and state approvals and permits required for the manufacture, importation, design, testing, inspection, labeling, warning, instructions for use, marketing, sale and distribution of the Product in the Territory.  UT shall promptly notify DISTRIBUTOR in writing upon receiving applicable FDA approvals, and such notice shall include the effective date of such approval, as well as the significant terms, conditions and limitations of such approval (including applicable indications), and UT shall also notify DISTRIBUTOR in writing of the effective date of Commercial Launch.

9.2

Compliance with Laws .  UT shall be solely responsible for, and comply with, all applicable federal and state laws, regulations and orders governing the regulation of the manufacture, importation, design, testing, inspection, labeling, sale, warning and instructions for use of all Product in the Territory, or otherwise applicable to the performance of its obligations under this Agreement.  DISTRIBUTOR shall comply with all applicable federal and state laws, regulations and orders governing its distribution and sale of Products in the Territory, or otherwise applicable to the performance of its obligations hereunder.  Each Party shall conduct its activities hereunder in and ethical and professional manner.

9.3

Inspection .  Each Party shall notify the other Party promptly of any inspection by any federal, state, or local regulatory representative concerning any Product and

shall provide the other Party with a summary of the results of such inspection and such actions, if any, taken to remedy conditions cited in such inspections.  Each Party agrees to cooperate with any inspection of a Product shipment conducted by a governmental agency.

9.4

Adverse Event Reporting .  Each Party agrees to inform the other Party promptly (but in no event no later than forty-eight (48) hours after becoming aware of same) of any complaint, or labeling or package insert issues, involving a Product or adverse drug experience (as defined in 21 C.F.R. 314.80), injury, toxicity, or sensitivity reaction associated with the clinical use of the Product, whether or not considered related to the Products.

(a)

If the adverse drug experience is serious, as defined in 21 C.F.R. 314.80 (including any adverse drug reaction that is fatal or life-threatening, is permanently disabling, requires inpatient hospitalization, or is a congenital anomaly, cancer or overdose), then each Party shall notify the other Party within twenty-four (24) hours;

(b)

All notifications to UT shall be by facsimile and on UT’s designated adverse event forms.

(c)

To the extent of any conflict between the provisions of this Section and Attachment E to this Agreement, the provisions of this Section shall control.

9.5

Withdrawal of Product .  If there is a recall of withdrawal of a Product, then UT shall immediately contact DISTRIBUTOR’s corporate purchasing department in accordance with DISTRIBUTOR’s policies and procedures made available to UT, and DISTRIBUTOR agrees to stop shipping recalled lots immediately, and in no event later than twenty-four (24) hours after DISTRIBUTOR receives written notification of such recalls.  DISTRIBUTOR shall cooperate fully in any such recall, including any customer notice, restriction, change, corrective act or market action or any Product change requested or ordered by any governmental agency having jurisdiction in the Territory.  UT agrees to reimburse DISTRIBUTOR for any reasonable cost or expenses (including reasonable attorneys’ fees) DISTRIBUTOR may incur due to recalls, withdrawals, replacements or government inspections of any Product.  DISTRIBUTOR shall prepare an invoice of such costs which invoice shall be paid by UT within thirty (30) days of receipt of such invoice.  Each party shall promptly provide the other party with copies of correspondence to or from governmental authorities relating to corrective action in the Territory concerning the Products.

9.6

Visits by Parties .  Each Party shall permit the other Party to visit its place of business and inspect its records, inventories and other relevant materials relating solely to its performance of this Agreement, upon reasonable advance notice and during normal business hours.

11.1

Trademark License Grant .  UT hereby grants to DISTRIBUTOR, and DISTRIBUTOR hereby accepts from UT, a nonexclusive, nontransferable, and royalty-free right and license, during the term of this Agreement, to reproduce and use the UT Trademarks in connection with the distribution, marketing, promotion and sale or other distribution of the Products in the Territory and in accordance with UT’s standards and instructions and for no other purpose.  DISTRIBUTOR shall not use any other marks or trade names in connection with the marketing and distribution of the Products, except that DISTRIBUTOR may use its marks or trade names in a manner consistent with its normal course of business, such as adding a label on the packaging identifying DISTRIBUTOR as a distributor of Products, such label to be approved by UT in advance in writing as to size and content, such approval not to be unreasonably withheld or delayed, and such use shall not confer on UT any rights or license in DISTRIBUTOR’s marks or trade names.  UT may inspect and monitor DISTRIBUTOR’s use of the UT Trademarks.  DISTRIBUTOR shall not remove or alter any UT trade names, trademarks, copyright notices, serial numbers, labels, tags or other identifying marks, symbols or legends affixed to any Products, documentation or containers or packages.

11.2

Registration .  In its sole discretion, UT may register the UT Trademarks in the Territory if UT determines that registration is necessary or useful to the successful distribution of the Products.  In addition, if UT believes that it is advisable to effect any filing or obtain any governmental approval or sanction for the use by DISTRIBUTOR of any of UT Trademarks pursuant to this Agreement, the Parties shall cooperate to do so.  All expenses relating to the registration of the UT Trademarks in the Territory as well as the making of any filing or obtaining any governmental approvals for the use by DISTRIBUTOR of the Trademarks shall be borne by UT.

11.3

Termination of Use .  Immediately upon termination of this Agreement, DISTRIBUTOR shall cease and desist from use of any UT Trademark in any manner, other than to liquidate its then-existing inventory of the Products within six months of such termination.  DISTRIBUTOR hereby grants to UT or its designee, in the event of such termination, full power of attorney, with the right of substitution, to cancel, revoke or withdraw any governmental registration or authorization permitting DISTRIBUTOR to use any UT Trademark in the Territory, and DISTRIBUTOR shall provide such further documentation and assistance as UT may reasonably request in connection therewith.

11.4

Reservation of Rights .  DISTRIBUTOR acknowledges UT’s proprietary rights in and to any UT Trademark, subject to the license and right granted in Section 11.1.  DISTRIBUTOR shall not adopt, use or register any words, phrases or symbols which are identical to or confusingly similar to any UT Trademark and shall not use any UT Trademark as part of DISTRIBUTOR’s corporate or trade name or permit any third party to do so.

11.5

Infringements .  DISTRIBUTOR shall promptly notify UT if it becomes aware of any use in the Territory by any third party of any UT Trademark or of any similar mark which may constitute an infringement of a UT Trademark.  Subject to the provisions of this Section, UT shall have the exclusive right, in its sole discretion, to institute proceedings against third-party infringers in respect of infringements occurring in the Territory.  If UT elects not to institute such proceedings within a period of thirty (30) days after notification of the alleged infringement, DISTRIBUTOR shall have the option to do so, and UT shall thereafter refrain from doing so.  UT shall have the exclusive right in its sole discretion to institute proceedings against third-party infringers in respect of infringements occurring outside the Territory.  Each Party shall cooperate fully with the other Party in connection with any such proceedings against third-party infringers, provided that all expenses of such proceedings shall be borne by the Party instituting same and all damages which may be awarded or agreed upon in settlement of such action shall accrue to such Party.

12.1

Insurance .  Each Party 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 shall promptly after the execution of this Agreement designate the other party as an additional named insured on such policies.  The deductible for such policy shall be no more than One Hundred Thousand Dollars ($100,000) and shall provide for ten (10) days’ notice to the other party by the insurer by registered or certified mail, return receipt requested, in the event of any modifications, cancellations or terminations thereof.  Each Party agrees to provide the other Party with a certificate of insurance evidencing compliance with this section within ten (10) days of execution of this Agreement.

12.2

DISTRIBUTOR Indemnification of UT .  Except as provided in Section 12.3, DISTRIBUTOR shall indemnify, defend and hold harmless UT and its Affiliates, and their respective officers, directors, employees, agents and successors and assigns from and against, any Claim to the extent such claim relates to or is based on (a) property damage, personal injury or death resulting from DISTRIBUTOR’s negligent or reckless provision or maintenance of the Products (except to the extent the same results from any wrongful act or omission of UT), (b) DISTRIBUTOR’s violation of any applicable law or governmental regulation or (c) any breach by DISTRIBUTOR of any of its representations, warranties, covenants or agreements in this Agreement.  For the purpose of this Section and Section 12.3, a “Claim” shall be any liabilities, damages, costs or expenses, including, without limitation, reasonable attorneys’ fees which arise from any claim, lawsuit, demand or other action by any Party other than one of the Parties or an Affiliate of one of the Parties.

12.3

UT Indemnification of DISTRIBUTOR for UT Products .  Except as provided in Section 12.2, UT shall indemnify, defend and hold harmless DISTRIBUTOR and its Affiliates, and their respective officers, directors, employees, agents and successors and assigns from and against any Claim to the extent such Claim relates to or is based on (a) UT’s design, manufacture or supply of the Products, (b) property damage, personal injury or death resulting from use of the Product (except to the extent the same results from any wrongful action or omission of DISTRIBUTOR), (c) UT’s violation of any applicable law or governmental regulation, (d) any breach by UT of any of its representations, warranties, covenants or agreements in this Agreement, (e) any inability of DISTRIBUTOR to supply Products to an Included Patient as a result of a shortage of product or other failure of UT to deliver Product (except to the extent the same results from any wrongful action or omission of DISTRIBUTOR), (f) any recall or withdrawal of Product, or return of damaged, defective, shortdated or outdated Product, or (g) any claim that DISTRIBUTOR’S distribution and sale of Products infringes on the patent, trade mark, copyright, or other proprietary rights of any third party.  To the extent of any conflict between the provisions of this Section and the provisions of Attachment E to this Agreement, this Section shall control.

12.4

UT Indemnification of DISTRIBUTOR for MiniMed Products .  UT shall indemnify, defend and hold DISTRIBUTOR harmless from and against any and all Claims relating to product liability claims with respect to MiniMed Products which are designed, developed and manufactured solely and independently by MiniMed, Inc.

12.4

Indemnification Procedure .  A Party seeking indemnification under this Article 12.0 (“Indemnified Party”) shall give prompt written notice to the indemnifying party (“Indemnifying Party”) of any Claim covered by the indemnification obligations hereunder; provided, however, that a delay in such notice shall not terminate the Indemnifying Party’s indemnification obligations hereunder, unless such delay shall have materially impaired the defense of such Claim.  Such Indemnifying Party shall have sole and exclusive control of the defense of any

such Claim, including the choice and direction of any legal counsel, provided, however, if a single legal counsel would be subject to a material conflict of interest under the applicable rules of professional conduct governing such counsel, the Indemnified Party shall not be obligated to waive such conflict and may request separate legal counsel at the Indemnifying Party’s expense.  The Indemnifying Party may not settle or compromise any such Claim without the written consent of the Indemnified Party, which consent shall not be unreasonably withheld.

12.5

Litigation Support .  In the event and for so long as an Indemnifying Party actively is contesting or defending against any Claim in connection with this Article 12.0, the Indemnified Party shall cooperate with the Indemnifying Party and its counsel in the contest or defense, make available its personnel, and provide such testimony and access to its books and records as shall be reasonably necessary in connection with the contest or defense, all at the sole cost and expense of the Indemnifying Party.

12.6

Subrogation .  The Indemnifying Party shall be subrogated to the rights of the Indemnified Party against any third party, and such Indemnified Party hereby assigns to the Indemnifying Party all claims, causes of action and other rights which the Indemnified Party may then have against any third party.  Conversely, and without in any way limiting the obligation of either Party to indemnify the other Party as herein provided, to the extent that an Indemnifying Party fails to perform its indemnification obligations under Section 12.2 or Section 12.3 above, the Indemnifying Party hereby assigns to the Indemnified Party all claims, cause of action and other rights which the Indemnifying Party may then have against any third party with respect to any Claim for which indemnification is provided hereunder.

13.0

Each Party agrees that during the term of this Agreement, and for a period of one year after the effective termination date, it shall not, without the other Party’s written consent, employ or retain on an independent contracting basis any person who was, at any time during the immediately preceding twelve (12) month period, employed by the other Party or any of its Affiliates.

14.1

Public Disclosure .  If either Party wishes to make a public disclosure concerning this Agreement or the relationship established hereunder and such disclosure mentions the other Party by name or description, such other Party shall be provided with an advance copy of the disclosure and shall have two (2) business days within which to approve or disapprove such use or its name of description (including mention of the name of the Product) provided, however:

(a)

Approval shall not be unreasonably withheld by either Party. Failure to respond within two (2) business days shall be deemed approval.

(b)

Absent approval, no disclosure shall use the name of or otherwise describe such Party except to the extent required by law, or the extent that the description of the other Party is limited to public information about the availability of the Product.

14.2

Filings with SEC .  Notwithstanding the foregoing, each Party acknowledges that both parties are or are affiliates of a publicly traded company and each Party hereby consents to the disclosure of this Agreement and the relationship between the Parties in their respective filings with the Securities and Exchange Commission and their disclosures to its stockholders; provided, however, that each Party shall use its commercially reasonable efforts not to disclose the specific financial terms and conditions of this Agreement except when such disclosure is required by law.

15.1

Notice .  A Party affected by an event of Force Majeure shall promptly provide the other Party with written notice describing the event, its cause and foreseeable duration, and its possible consequences upon performance under this Agreement.

15.2

Suspension of Performance .  After an affected Party has given notice under Section 15.1, that Party shall be relieved of any performance obligation under this Agreement for obligations which the Force Majeure event prevents, but only to the extent and only for so long as the Force Majeure prevents performance.  The other Party may likewise suspend the performance of all or part of its obligations, except for the obligation to pay any amounts due and owing, and confidentiality, indemnification, record-keeping and audit, and dispute resolution obligations of this Agreement, to the extent that such suspension is commercially reasonable.

15.3

Termination .  If the period of Force Majeure continues for more than sixty (60) days, either Party may terminate this Agreement upon giving notice to the other Party without incurring liability other than the obligation to make payments due to such date.

16.1

Term .  The initial term of this Agreement shall begin on the Effective Date and shall continue in force through three (3) years from the Commercial Launch date (the “Initial T