Common use of Manufacturing Practices Clause in Contracts

Manufacturing Practices. (a) The Supplier of an Alliance Product will manufacture (or have manufactured) such Alliance Product in conformity with its written specifications and in accordance with all applicable laws and regulations. If a Supplier is unable to supply pursuant to the terms of this Agreement an FDA-approved or FDA-cleared Alliance Product due to non-compliance with FDA regulations, such event, subject to Sections 6.2(b) and (c), will be deemed [***] indicates material that has been omitted pursuant to a request for confidential treatment. The omitted material has been filed separately with the Securities and Exchange Commission. a material breach of this Agreement and the other Party may terminate this Agreement pursuant to Section 17.4 or 17.5, as the case may be. (b) For purposes of this Section 6.2, such inability to supply will only be deemed material if: (i) the duration of the inability to supply is at least [***]; and either (ii) the Sales Revenue generated by the affected Alliance Product is greater than [***] percent ([***]%) of the total Sales Revenue of all Alliance Products, both as measured during the [***] period immediately preceding the inability to supply; or (iii) the affected Alliance Product provided at least [***] in Margin (as defined below) to the Alliance Program during the [***] period immediately preceding the inability to supply. For purposes of this Section 6.2, “Margin” means Distribution Margin (as defined below) of the affected Alliance Product, less: (A) Marketing and Advertising Expenses; (B) Selling and Promotion Expenses; and (C) General and Administrative Expenses. For further purposes of this Agreement, “Distribution Margin” means Sales Revenue and Service Revenue less Cost of Goods Sold.

Manufacturing Practices. (a) The Supplier of an Alliance Product will manufacture (or have manufactured) such Alliance Product in conformity with its written specifications and in accordance with all applicable laws and regulations. If a Supplier is unable to supply pursuant to the terms of this Agreement an FDA-approved or FDA-cleared Alliance Product due to non-compliance with FDA regulations, such event, subject to Sections 6.2(b) and (c), will be deemed [***] indicates material that has been omitted pursuant to a request for confidential treatment. The omitted material has been filed separately with the Securities and Exchange Commission. a material breach of this Agreement and the other Party may terminate this Agreement pursuant to Section 17.4 or 17.5, as the case may be.. [**********] Indicates omitted material that is the subject of a confidential treatment request filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended. Back to Contents (b) For purposes of this Section 6.2, such inability to supply will only be deemed material if: (i) the duration of the inability to supply is at least least[**********]; and either (ii) the Sales Revenue generated by the affected Alliance Product is greater than [**********] percent ([**********]%) of the total Sales Revenue of all Alliance Products, both as measured during the [**********] period immediately preceding the inability to supply; or (iii) the affected Alliance Product provided at least [**********] in Margin (as defined below) to the Alliance Program during the [**********] period immediately preceding the inability to supply. For purposes of this Section 6.2, “Margin” means Distribution Margin (as defined below) of the affected Alliance Product, less: (A) Marketing and Advertising Expenses; (B) Selling and Promotion Expenses; and (C) General and Administrative Expenses. For further purposes of this Agreement, “Distribution Margin” means Sales Revenue and Service Revenue less Cost of Goods Sold.