LICENSE AND SUPPLY AGREEMENT

1.

Definitions .

1.1.

“ Affiliate ” is, with respect to a Party, any entity during the Term that controls, is controlled by, or is under common control with, that Party. For purposes of this definition, an entity shall be deemed to control another entity if that entity owns or controls, directly or indirectly, more than fifty percent (50%) of the voting control of all equity interests of the other entity (or other comparable ownership interest for an entity other than a corporation).

1.2.

“ Agreement ” is this License and Supply Agreement as executed by both Parties, and as may be amended in accordance with the provisions hereof.

1.3.

“ aNDA ” is the Abbreviated New Drug Application #75-117 and/or submissions, amendments, modifications, supplements and updates thereto, approved by the FDA related to the marketing and sale of the Branded Product and the Product.

1.4.

“ Authorized Wholesaler ” is one or more wholesalers, distributors, and/or customers of Hi-Tech for the Territory, including those who have previously

agreed to provide Hi-Tech with monthly utilization reports at Hi-Tech’s cost, showing their respective aggregate sales of Product in the Territory for each calendar month during the Term. Hi-Tech shall provide BioMarin with an accurate updated list of all Authorized Wholesalers at the start of each Quarter.

1.5.

“ cGMP ” are current Good Manufacturing Practices, as defined by the FDA pursuant to applicable statutes and the regulations adopted from time to time under the authority of the United States Food, Drug and Cosmetics Act.

1.6.

“ Competitive Product ” is any prescription drug that is listed as pharmaceutically equivalent to the Branded Product as listed in the FDA Orange Book, other than the Product sold pursuant to this Agreement.

1.7.

“ Confidential Information ” is all information of a Party as and to the extent described in Article 16 .

1.8.

“ Effective Date ” is the date first above written.

1.9.

“ Executive Committee ” is a committee, comprised of two (2) employees or officers from each Party, which shall meet not less than two (2) times per year at mutually agreed upon dates, times, and places to make decisions regarding the matters set forth in Article 3 .

1.10. 

“ FDA ” is the United States of America Food and Drug Administration and any successor thereto.

1.11. 

“ Hi-Tech Expenses ” are those costs incurred for Hi-Tech Promotional Efforts or for advertising and marketing of Product and/or multiple items or services.

1.12. 

“ Hi-Tech Product Materials ” are all forms and formats of information produced by or at the request of Hi-Tech regarding or describing, in whole or in part, the Product.

1.13. 

“ Hi-Tech Promotional Efforts ” are all of Hi-Tech’s activities to promote and have the Product sold and used in the Territory pursuant to the provisions of this Agreement.

1.14. 

“ Hi-Tech Representative ” is a Hi-Tech employee and sales person who makes sales presentations for the Product.

1.15. 

“ Medical Affairs Liaison ” of each Party shall be an employee appointed by that Party to facilitate the communications described in Article 10 .

1.16. 

“ Net Sales ” is equal to Hi-Tech’s and its Affiliates’ gross receipts, calculated on the accrual basis, using generally accepted accounting principles, from all sales and distribution of all Product in the Territory, less the following to the extent directly related to a Product:

(a)

returns and refunds allowance to be determined at the time of sale for expired product and other product to be returned in the ordinary course of business determined in accordance with GAAP; provided that in no event will such allowance exceed [****];

(b)

returns and refunds actually made for defective or recalled Product;

(c)

freight and insurance actually incurred by Hi-Tech for the shipment and delivery of Product to Purchasers;

(d)

rebates and chargebacks including but not limited to any statutory or contractual rebates and management fees based on Product sales volume and statutory rebates;

(e)

off invoice and other allowances and discounts paid or credited by Hi-Tech directly related to the purchase of the Product; provided, however, any discounts granted or earned in connection with prompt payment terms shall not exceed [****];

(f)

Amounts paid by Hi-Tech to BioMarin pursuant to Sections 7.2 and 7.3 .

1.17. 

“ Product ” is a prednisolone sodium phosphate 15mg (base)/5mL oral solution that is a generic form of the Branded Product to be manufactured and sold pursuant to the aNDA.

1.18. 

“ Purchasers ” are any person or entity purchasing the Product, including but not limited to wholesalers, distributors, and direct purchasers.

1.19. 

“ Quarter ” is a three (3) consecutive calendar month period starting on January 1, April 1, July 1, or October 1 during the Term.

1.20. 

“ Term ” is the period on and after the Effective Date until termination of this Agreement in accordance with Article 13 .

1.21. 

“ Territory ” is the United States of America, and all its territories and possessions.

1.22. 

“ Unit ” is a single 237 mL container of Product.

2.

Appointment .

2.1.

BioMarin hereby appoints Hi-Tech as the authorized and exclusive marketing entity, distributor and seller of all Product in the Territory for the Term.

2.2.

BioMarin retains the right to develop, promote, license, sell, and otherwise commercially exploit any and all branded pharmaceutical products (including but not limited to the Branded Product and other strengths of the Branded Product) and other products in the Territory during the Term; BioMarin does not have the right to promote, license, or sell the Product in the Territory during the Term; Hi-Tech

hereby agrees it shall have no interest of any kind arising out of, or as a result of, this Agreement, in anything other than its marketing, selling and distribution rights to the Product in the Territory.

3.

Executive Committee . Within ten (10) days after the Effective Date, Hi-Tech and BioMarin shall each appoint two (2) of their respective employees to meet within thirty (30) calendar days of the Effective Date and at least twice during each calendar year thereafter, to agree upon, establish, and update each of the following by a majority vote of all members of the Executive Committee:

3.1.

Rolling, 12-month, targets and/or goals for market share for the Product;

3.2.

The gross sales price for the Product charged by Hi-Tech and the minimum Net Sales price;

3.3.

All methods and means proposed to conduct all Hi-Tech Promotional Efforts, and the scope thereof; and

3.4.

Such other matters as either Party may bring before the Executive Committee pursuant to the terms of this Agreement.

4.

Hi-Tech Promotional Efforts .

4.1.

Hi-Tech shall use commercially reasonable efforts to promote the Product for sale in the Territory.

4.2.

During the Term, Hi-Tech, by and through the Hi-Tech Representatives, shall perform all Hi-Tech Promotional Efforts in accordance with the terms of this Agreement. Hi-Tech shall consult with BioMarin from time to time with respect to the manner in which Hi-Tech promotes the Product.

4.3.

Hi-Tech shall perform Hi-Tech Promotional Efforts for the Product in accordance with all applicable Federal, state, and local laws and regulations of the Territory including, but not limited to, all applicable FDA regulations.

4.4.

As part of the Hi-Tech Promotional Efforts, Hi-Tech Representatives shall distribute Hi-Tech Product Materials to potential and existing Purchasers and to others to whom the Hi-Tech Representatives make Hi-Tech Promotional Efforts.

4.5.

Hi-Tech shall use commercially reasonable efforts to timely produce and distribute the highest quality Hi-Tech Product Materials and make Hi-Tech Promotional Efforts during the Term.

4.6.

Hi-Tech will develop and make one or more presentations to each of its customers who may be a Purchaser.

4.7.

Hi-Tech agrees that all sales, contracting, supervision, administration, accounting, and reporting performed by Hi-Tech employees pursuant to this Agreement shall be at Hi-Tech’s sole cost and expense and shall in no event result in a deduction against Net Sales. Hi-Tech shall have exclusive responsibility for training Hi-Tech Representatives in the promotion of the Product.

4.8.

During the Term, Hi-Tech shall not market or sell any Competitive Product.

5.

Product Distribution .

5.1.

Product Requirements .

(a)

Hi-Tech agrees to comply with all Federal, state, and local, laws and regulations of the Territory applicable or relating to the purchase, storage, distribution, handling, sale, or dispensing of the Product.

(b)

Hi-Tech shall instruct its Authorized Wholesalers in the proper storage of Product, in accordance with BioMarin’s written recommendations and the product label as approved by the FDA.

(c)

Hi-Tech agrees to immediately advise BioMarin of any change in, or revocation of, any of Hi-Tech’s or of any Authorized Wholesaler’s governmental, regulatory, manufacturing, professional, wholesaler, distributor, or warehouse registrations or licenses.

(d)

Hi-Tech shall accept all Product returns in the Territory during the Term and account for, track, handle, and dispose of all Product returned by Authorized Wholesalers and others in the Territory, in accordance with all laws, ordinances, regulations and rules applicable for the Territory. Other than recalls or returns of defective product, Hi-Tech shall have sole financial responsibility for all Product returns.

5.2.

Electronic Database .

(a)

Hi-Tech shall use a computerized database to accurately account for all Product orders and to calculate Net Sales.

(b)

The database shall contain and be capable of reporting to BioMarin:

(i)

gross receipts and Unit sales on a monthly basis;

(ii)

Net Sales on a monthly basis; and

(iii)

Each item comprising the difference between gross receipts and Net Sales.

(c)

Hi-Tech shall take all necessary steps to assure appropriate back-up and information storage for the database, including the ability to retrieve and print a copy of any source document.

(d)

Hi-Tech shall make all information described in this Section 5.2 available to BioMarin electronically at all times during the Term, for calculation of BioMarin’s royalty.

5.3.

Hi-Tech Reports for Calculation of BioMarin Royalty .

(a)

Hi-Tech Reports . Not later than thirty (30) days after the end of each Quarter during the Term, Hi-Tech shall supply BioMarin with a report summarizing the Hi-Tech Promotional Efforts, Net Sales, and Hi-Tech Expenses during such Quarter. The format, content, and detail of reports required by this Section 5.3 shall be as reasonably requested by BioMarin.

(b)

Audit . If BioMarin determines in its reasonable judgment that a review of Hi-Tech’s relevant books and records is necessary to verify the figures reported or to be reported, then upon reasonable prior written notice to Hi-Tech, and not more than once in any twelve (12) month period, Hi-Tech shall allow BioMarin and/or its auditors during normal business hours to review and conduct an audit at BioMarin’s expense of any and all Hi-Tech books, records, and documents regarding gross receipts from the Product, Net Sales, Hi-Tech Expenses, and a review of any and all of Hi-Tech’s other books and records regarding or relating to Product sales, costs, and all activities related thereto in the Territory, during the Term.

(c)

Corrective Payments . If BioMarin’s audit reveals that Hi-Tech has under-reported aggregate Net Sales to BioMarin, then:

(i)

If the inaccuracy is [****], Hi-Tech shall refund to BioMarin all under-reported royalties upon Net Sales within [****] following completion of the audit; and

(ii)

If the inaccuracy is [****], then Hi-Tech shall refund to BioMarin all under-reported royalties upon Net Sales, plus all reasonable costs of BioMarin’s audit, all within [****] following completion of the audit.

6.

Regulatory Matters . BioMarin shall be solely responsible for all regulatory matters in the Territory relating to the Product, the Branded Product and the aNDA . Each Party shall fully cooperate with the other with respect to all regulatory matters within the Territory. Hi-Tech shall promptly reimburse BioMarin upon request for all regulatory expenses incurred by BioMarin, including reasonable internal costs, associated with the Product.

7.

Product Supplied .

7.1.

Exclusive Supply . BioMarin shall arrange for all Product to be manufactured on Hi-Tech’s behalf by Lyne Laboratories Inc. (“ Lyne ”) under a Supply Agreement attached hereto as Exhibit A (the “ Supply Agreement ”). Hi-Tech shall be responsible for providing text and copy for Product labels and package inserts, subject to BioMarin’s prior approval, not to be unreasonably withheld or delayed.

Within [****] after the Effective Date, the Parties will complete a quality agreement to provide for SOPs for the Product delivery, documentation, and complaint reporting, investigation, coordinating and adjudicating.

7.2.

Purchase Orders . Hi-Tech will place firm purchase orders for the Product with BioMarin, at least [****] prior to the scheduled delivery date and otherwise consistent with the timing and limitations contained in the Supply Agreement. To the extent that Hi-Tech requires quantities of Product on conditions other the foregoing, Hi-Tech may place purchase orders for such Product and BioMarin shall use commercially reasonable efforts to accommodate such purchase orders; provided that BioMarin shall not be in breach of this Agreement for failing to meet such purchase orders and shall not be required to delay any scheduled production of Branded Product to meet such purchase orders. The invoice price for each Unit will be [****]. Payment is due net [****].

7.3.

BioMarin Distribution . At Hi-Tech’s request, BioMarin will arrange for the storage and shipping of the Product to Purchasers. In the event that BioMarin is responsible for such storage and shipping, within [****] after such request, the Parties shall establish mutually acceptable SOPs for order receipt, shipping methods and tracking and related matters. Within [****] after the end of each calendar month, BioMarin shall invoice Hi-Tech for all out of pocket expenses incurred in connection with the storage, transportation and distribution of the Product (whether BioMarin is shipping product to Hi-Tech or to Purchasers). Payment for such invoices shall be due net [****].

7.4.

Product Recall . If any Product is recalled due to manufacturing defects, then BioMarin shall be responsible for all reasonable expenses relating to such recall and for all activities to be performed at BioMarin’s request relating to such recall.

7.5.

Pricing Strategies . Parties hereto will mutually agree on Hi-Tech’s prices and pricing strategies. In no event will Hi-Tech make any sale of Product where the Net Sales per Unit is less than [****], without BioMarin’s prior written consent, which may be granted or withheld in BioMarin’s sole and absolute discretion.

7.6.

Territory . Hi-Tech and Authorized Wholesalers shall purchase, distribute, transfer, and sell Product only for use within the Territory, and shall not, directly or indirectly, permit or allow any Product to be directly or indirectly transferred outside the Territory for any reason.

7.7.

Inspection and Reports . BioMarin shall advise Hi-Tech of any FDA or other governmental agency visits any facility where Product is manufactured to perform an inspection or requests or requires information or changes which directly pertain to the Products. BioMarin shall furnish to Hi-Tech copies of all FDA Forms 482 and 483 related to the Product given by the FDA promptly upon receipt. Further, BioMarin shall advise Hi-Tech of any inspections of Lyne performed by BioMarin and shall provide Hi-Tech with the reports created by BioMarin related to such inspections and will discuss with Hi-Tech any material deficiencies identified by BioMarin.

8.

Product Materials .

8.1.

Product Labeling . All Product labeling decisions shall be made by Hi-Tech with BioMarin’s approval. Product labels shall not bear BioMarin’s name, logo, trademarks, or any other identifying material.

8.2.

Use of Trademarks . All trade names, trademarks, service marks, copyrights, patents, approvals, licenses, and permits are and shall remain the sole and separate property of the owner thereof and, at the end of the Term, all licenses and rights of use in and to the other Party granted by this Agreement shall cease.

9.

Royalty Payments .

9.1.

In exchange for the rights granted to Hi-Tech, BioMarin shall be entitled to receive [****]. Such amounts shall be payable Quarterly, within [****] of the end of the Quarter in which accrued.

9.2.

Upon [****] prior written notice provided by BioMarin to Hi-Tech with regard to any payment due hereunder, past-due balances are subject to interest at the rate of one and [****] per month [****], or the highest amount allowed by law, whichever is lower, plus all reasonable attorneys’ fees and court costs incurred by BioMarin in collecting payment.

10.

Medical Inquiries; Notification Of Adverse Drug Experience .

10.1.

Communication . Within ten (10) days after the Effective Date, each Party shall appoint a Medical Affairs Liaison to communicate with the other Party’s Medical Affairs Liaison regarding information required pursuant to this Article 10 . Either Party may change its Medical Affairs Liaison by notice to the other Party.

10.2.

Notification . During the Term, Hi-Tech shall give BioMarin notice of any adverse drug experience associated with any Product as to which Hi-Tech obtains information, as follows:

(a)

Any adverse drug experience information required to be reported to the FDA by or on behalf of Hi-Tech or in the Territory shall also be reported to BioMarin’s Medical Affairs Liaison, by telephone or by facsimile, within twenty-four (24) hours after Hi-Tech’s initial receipt of any such information;

(b)

Hi-Tech’s reports to BioMarin shall contain the:

(i)

date Hi-Tech first received information regarding an adverse drug experience;

(ii)

name of the reporter and the reporter’s title;

(iii)

address and telephone number of the reporter;

(iv)

description of the adverse drug experience;

(v)

indication for treatment;

(vi)

outcome of the event;

(vii)

dose and duration of treatment; and

(viii)

lot number of the Product, if available.

(ix)

such other information as may be required to complete the MedWatch reporting.

(c)

Hi-Tech shall maintain a record of any adverse drug experience required to be reported to the FDA, including:

(i)

a copy of the drug experience report generated by Hi-Tech necessary to allow BioMarin to make appropriate filings with the FDA;

(ii)

the date Hi-Tech first received information regarding an adverse drug experience; and

(iii)

the date such report was provided to BioMarin.

10.3.

Investigation and Regulatory Follow Up . Hi-Tech shall coordinate any investigation of an adverse drug experience with BioMarin’s Medical Affairs Liaison and shall cooperate with any reasonable requests by such