“Generic Product” means, with respect to a Licensed Product, any product that # is sold by a Third Party that is not a licensee or Sublicensee of [[Organization A:Organization]] or its Affiliates, or any of their licensees or Sublicensees, under a Drug Approval Application granted by a Regulatory Authority to a Third Party, # contains the Licensed Compound as an active ingredient, and # is approved in reliance, in whole or in part, on the prior approval (or on safety or efficacy data submitted in support of the prior approval) of such Licensed Product as determined by the applicable Regulatory Authority, including any product authorized for sale # in the U.S. pursuant to [Section 505(b)(2)] or [Section 505(j)] of the FFDCA (21 U.S.C. 355(b)(2) and 21 U.S.C. 355(j), respectively), # in the E.U. pursuant to a provision of Articles 10, 10a or 10b of Parliament and Council Directive 2001/83/EC as amended (including an application under Article 6.1 of Parliament and Council Regulation (EC) No 726/2004 that relies for its content on any such provision), or # in any other country or jurisdiction pursuant to all equivalents of such provisions, including any amendments and successor statutes with respect to the [subsections (a) through (c)] thereto. A Licensed Product licensed or produced by [[Organization A:Organization]] or one of its Affiliates (i.e., an authorized generic product) will not constitute a Generic Product.

Tenant’s Authorized Representative. Tenant designates Steve Prestrelski and Dean Petersen (either such individual acting alone, “Tenant’s Representative”) as the only persons authorized to act for Tenant pursuant to this Work Letter. Landlord shall not be obligated to respond to or act upon any request, approval, inquiry or other communication (“Communication”) from or on behalf of Tenant in connection with this Work Letter unless such Communication is in writing from Tenant’s Representative. Tenant may change either Tenant’s Representative at any time upon not less than 5 business days advance written notice to Landlord. Neither Tenant nor Tenant’s Representative shall be authorized to direct Landlord’s contractors in the performance of Landlord’s Work (as hereinafter defined).

ADJUSTMENTS IN AUTHORIZED SHARES. In the event of any change in corporate capitalization, such as a stock split, or a corporate transaction, such as any merger, consolidation, separation, including a spin-off, or other distribution of stock or property of the Company, any reorganization (whether or not such reorganization comes within the definition of such term in Code Section 368), or any partial or complete liquidation of the Company, such adjustment shall be made in the number and class of Shares available in the Share Pool and in the number and class of and/or price of Shares subject to outstanding Awards granted under the Plan, as may be determined to be appropriate and equitable by the Committee, in its sole discretion, to prevent dilution or enlargement of rights; provided, however, that the number of Shares subject to any Award shall always be a whole number.

Authorized and Reserved Shares. The Borrower covenants that at all times until the Note is satisfied in full, the Borrower will reserve from its authorized and unissued Common Stock a sufficient number of shares, free from preemptive rights, to provide for the issuance of a number of Conversion Shares equal to the greater of: # 11,220,000 shares of Common Stock or # the sum of # the number of Conversion Shares issuable upon the full conversion of this Note (assuming no payment of Principal Amount or interest) as of any issue date (taking into consideration any adjustments to the Conversion Price pursuant to Section 2 hereof or otherwise) multiplied by # one and a half (1.5) (the “Reserved Amount”). The Borrower represents that upon issuance, the Conversion Shares will be duly and validly issued, fully paid and non-assessable. The Borrower # acknowledges that it has irrevocably instructed its transfer agent to issue certificates for the Conversion Shares or instructions to have the Conversion Shares issued as contemplated by [Section 1.4(f)] hereof, and # agrees that its issuance of this Note shall constitute full authority to its officers and agents who are charged with the duty of executing stock certificates or cause the Company to electronically issue shares of Common Stock to execute and issue the necessary certificates for the Conversion Shares or cause the Conversion Shares to be issued as contemplated by [Section 1.4(f)] hereof in accordance with the terms and conditions of this Note.

Authorized Number of Shares. Subject to adjustment under Section 9, Awards may be made under the Plan for up to 1,000,000 shares of common stock, $0.001 par value per share, of the Company (the “Common Stock”).

Adjustments in Authorized Shares. Adjustments in authorized Shares available for issuance under the Plan or under an outstanding Award and adjustments in Annual Award Limits shall be subject to the following provisions:

For purposes of this [Section 5.3(d)], the market share of a Licensed Product or Generic Product in a country shall be determined based on unit sales data provided by IMS International or, if such data is not available, such other reliable data source as mutually agreed by the Parties in good faith (such agreement not to be unreasonably withheld) in such country; provided however, that, in the event IMS International data (or data from another data source selected in accordance with the foregoing) is unavailable to determine the percentage market share for a country in the European Union where a Generic Product is being sold, the average market share for the countries in the European Union for which such data is available will be deemed to be the market share for such country in which such data is not available.

Covenant Not to Market Competing Products. Except as expressly contemplated by the terms of this Agreement, the Parties and their respective Subsidiaries shall not, and shall not negotiate to or agree to, # develop, file for Regulatory Approval, acquire, license, manufacture anywhere for use in the Territory, or # Market or otherwise commercialize in or for the Territory, any pharmaceutical product that is # a Generic Equivalent to a Product, # an AG Product with respect to a Product, or # any extended release or delayed release prescription cough/cold medicine containing codeine, either alone or with a Third Party (each, a “Competing Product”) during the Term of a Product. Notwithstanding the foregoing, clause (C) shall not prevent either Party from developing, manufacturing and Marketing, a Generic Equivalent (whose approval is or will be based on an ANDA) of a Third Party extended release or delayed release prescription cough/cold medicine containing codeine product which Third Party product was approved pursuant an NDA and such product shall not be deemed a Competing Product. If TRIS engages any Third Party to use TRIS’ modified release technology for liquid suspension products to manufacture Product, it shall enter into an agreement with such Third Party whereby such Third Party agrees not to Market a Generic Equivalent to such Product during the Term of such Product.

The price for Tuzistra XR shall be ​ per ​ bottle and ​ per ​ bottle; provided, further, however, that, notwithstanding anything to the contrary contained in this Agreement, there shall be no obligation for TRIS to supply such ​ size samples after a Third Party Generic Launch so long as AYTU’s Net Sales of Product (excluding AG Product) do not exceed ​ in any consecutive 12 month period.

by TRIS, upon thirty (30) calendar days prior written notice to AYTU, at any time after twenty-four (24) months following a Third Party Generic Launch, in the event that for any full calendar year commencing after such twenty-four month period, the sum of # TRIS’ Royalty Payments and # TRIS’ share of Gross Margin from the sale of AG Products is less than ​.