Common use of Minimum Requirement Clause in Contracts

Minimum Requirement. Subject to Catalent’s Minimum Supply Commitment (defined below), during each consecutive 12 month period (each a “Minimum Requirement Year”) beginning on the earlier of (i) date that the required Regulatory Authorities approve Catalent as a manufacturer of both Products and Client is authorized to commence selling both Products in the Territory (by approval of Client’s New Drug Application and completion of process validation for the Products), in which case the minimum set forth in Attachment C will apply to both Products; or (ii) [**] months after the date that the required Regulatory Authorities approve Catalent as a manufacturer of one Product and Client is authorized to commence selling that Product in the Territory (by approval of Client’s New Drug Application and completion of process validation for the applicable Product), in which case the minimum set forth in Attachment C will only apply to the approved Product until such time as the second Product is approved as required under Section 4.1(i) and at then to both Products. Client shall purchase the minimum number of units of Product set forth on Attachment C (“Minimum Requirement”). Client agrees to commence process validation on a per Product basis no later than [**] months following approval of Client’s New Drug Application for the applicable Product. If Client does not purchase such Minimum Requirement during any Minimum Requirement Year, then within [**] days after the end of such Minimum Requirement Year, Client shall pay Catalent the difference between (A) the total amount Client would have paid to Catalent if the Minimum Requirement had been fulfilled for the applicable Product and (B) the sum of all purchases of the applicable Product from Catalent during such Minimum Requirement Year. In the event that, as a result of a Regulatory Authority or other Force Majeure Event, Client is prevented from commercializing a Product, Client shall be relieved of the Minimum Requirement for so long as the Force Majeure Event remains; provided that Client use its best efforts to mitigate or remove such Force Majeure Event.

Minimum Requirement. Subject to Catalent’s Minimum Supply Commitment (defined below)During each Contract Year, during each consecutive 12 month period (each a “Minimum Requirement Year”) beginning on the earlier of (i) date that the required Regulatory Authorities approve Catalent as a manufacturer of both Products and Client is authorized to commence selling both Products in the Territory (by approval of Client’s New Drug Application and completion of process validation for the Products), in which case the minimum set forth in Attachment C will apply to both Products; or (ii) [**] months after the date that the required Regulatory Authorities approve Catalent as a manufacturer of one Product and Client is authorized to commence selling that Product in the Territory (by approval of Client’s New Drug Application and completion of process validation for the applicable Product), in which case the minimum set forth in Attachment C will only apply to the approved Product until such time as the second Product is approved as required under Section 4.1(i) and at then to both Products. Client shall purchase the minimum number of units volume of Product ("MINIMUM REQUIREMENT") set forth on Attachment C (“Minimum Requirement”). Client agrees to commence process validation on a per Product basis no later than [**] months following approval of Client’s New Drug Application for the applicable Product. B. If Client does not purchase such Minimum Requirement during any Minimum Requirement Year, then within [**] days after the end of such Minimum Requirement Contract Year, Client shall pay Catalent Cardinal Health the difference between (A1) the total amount Client would have paid to Catalent Cardinal Health if the Minimum Requirement had been fulfilled for the applicable Product and (B2) the sum of all purchases of the applicable Product from Catalent Cardinal Health for such Contract Year (the "MINIMUM REQUIREMENT BALANCE"); provided, however, that if subsequent to the close of the first Contract Year, Client experiences a Material Adverse Change and fails to purchase the Minimum Requirement during such Minimum Requirement Year. In the event that, Contract Year as a direct result of a Regulatory Authority or other Force Majeure Event, Client is prevented from commercializing a Productsuch Material Adverse Change, Client shall not be relieved required to pay the Minimum Requirement Balance to Cardinal Health for such Contract Year, but shall instead pay to Cardinal Health the greater of either (A) Cardinal Health's gross profit associated with Processing Product for such Contract Year, or (B) fifty percent (50%) of the Volume Price, associated with the difference between (x) the Minimum Requirement for so long such Contract Year and (y) the amount of Product Processed by Cardinal Health for such Contract Year. For the purposes of this Section 4.1, a "MATERIAL ADVERSE CHANGE" shall mean a decrease in the gross revenues of Client (including all Affiliates and sublicensees of Client, and successors and assigns) (as determined in accordance with generally accepted accounting principles) from sales of the Force Majeure Event remains; Mucinex(R) brand products during a Contract Year of * percent (*%) or more from gross revenues from sales of such products during the preceding twelve-month period (a "MATERIAL SALES DECREASE") due to the marketing and sale by an unaffiliated third party of a private label, extended release guaifenesin product. Cardinal Health shall have the right to request an audit of any Material Adverse Change claimed by Client hereunder. Such audit shall be performed by an independent certified public accountant who shall be permitted to review such of Client's records and accounts as are necessary to verify that a Material Sales Decrease has occurred. Cardinal Health shall have the further right to verify that a Material Adverse Change has occurred by review of such third party market reports and analyses, including without limitation, market reports and analysis provided by IMS Health Incorporated and other reputable information aggregators and providers, as Cardinal Health determines reasonably necessary to confirm that a private label, extended release guaifenesin product is currently available and has captured *% of the U.S. domestic market for extended release guaifenesin products during the relevant Contract Year (the "MARKET REQUIREMENT"). If such Market Requirement has been met, then the marketing and sale of such product shall be deemed to have caused the Material Sales Decrease for the purposes of determining whether a Material Adverse Change has occurred. If the audit permitted herein discloses that Client use its best efforts has not experienced a Material Sales Decrease or Cardinal Health is unable to mitigate or remove confirm that the Market Requirement has been met, then Client shall, in addition to any other amounts due to Cardinal Health hereunder, reimburse Cardinal Health for all costs and expenses incurred by Cardinal Health in connection with such Force Majeure Eventaudit.