Common use of Specification Changes Clause in Contracts

Specification Changes. Upon any change in the Active Ingredient Specifications or Packaging Specifications requested by Generex (“Generex Specification Changes”), including the addition of new packaging configurations, Generex shall promptly advise SAD in writing of any requested Generex Specification Changes, and SAD shall promptly advise Generex as to the feasibility of the Generex Specification Changes, and if in SAD’s reasonably exercised discretion, the Generex Specification Changes are found to be commercially reasonable and feasible, SAD will inform Generex of any scheduling and/or price adjustments which may result from the Generex Specification Changes. Prior to implementation of Generex Specification Changes, the Parties shall negotiate in good faith in an attempt to reach agreement on (a) the new Active Ingredient Price for any Active Ingredient which embodies the Generex Specification Changes, (b) any amounts to be reimbursed by Generex to SAD as described in the next sentence of this paragraph, and (c) any other amendments to this Agreement which may be necessitated by the Generex Specification Changes (i.e., an adjustment to the lead time for purchase orders). Generex shall reimburse SAD for the mutually agreed upon reasonable expenses incurred by S AD as a result of the Generex Specification Changes, including, but not limited to, reimbursing SAD for its mutually agreed validation and development costs, capital expenditure costs and costs for any reasonable inventory of packaging components or other materials maintained by SAD for purposes of this Agreement and consistent with any then-current Forecast, and rendered unusable as a result of the Generex Specification Changes. If during the Term, Generex, in accordance with this Article 5, causes the amendment of the Active Ingredient Specifications or Packaging Specifications so as to render obsolete reasonable quantities of the Active Ingredient and/or materials and components used to manufacture and package the Active Ingredient pursuant to this Agreement on hand at SAD, Generex shall purchase from SAD (i) all such obsolete Active Ingredient at the Active Ingredient Prices then in effect, (ii) all work-in-progress of the Active Ingredient at SAD’s actual cost thereof, and (iii) at SAD’s Acquisition Cost, all such obsolete materials and components obtained by SAD pursuant to its normal procurement policies to manufacture quantities of the Active Ingredient pursuant to Generex’ forecasts under Section 6.1. SAD’s normal procurement policies for purposes of the preceding sentence of this Article 5 shall be considered to be quantities of materials and components corresponding to the following six (6) months of Generex’s forecasted Active Ingredient demand. For greater certainty, the foregoing provisions of this Article 5 shall not apply in respect of any change in the Active Ingredient Specifications or Packaging Specifications made by SAD other than pursuant to a Generex request. SAD shall provide Generex with not less than six (6) months’ prior written notice of SAD’s implementation of any intended significant change(s) to its manufacturing processes for the Active Ingredient, which might affect the quality of the Active Ingredient (“Change Notice”) (e.g. Any change in the Active Ingredient Specifications or Packaging Specifications made by SAD other than pursuant to a Generex request). If a significant change implemented by SAD and Generex provides SAD with demonstrable evidence that the utility (i.e. the conditions of being useful as a pharmaceutical product in connection with the manufacture and performance of the Product) of the Active Ingredient is significantly altered in that there is no similar bioequivalence (to Active Ingredient before the significant change) or similar Product specifications when formulated in the final Product formulation (together, “Utility Loss”), the parties shall exert their best commercial efforts to resolve issues related to the Utility Loss in order to continue operating under this Agreement. If the parties cannot reach agreement and resolution regarding Utility Loss Generex shall have the option to provide sixty (60) days written notice of termination of this Agreement to SAD.

Specification Changes. Upon any change in the Active Ingredient Specifications or Packaging Specifications requested by Generex Buyer (“Generex Buyer Specification Changes”), including the addition of new packaging configurations, Generex Buyer shall promptly advise SAD in writing of any requested Generex Buyer Specification Changes, and SAD shall promptly advise Generex Buyer as to the feasibility of the Generex Buyer Specification Changes, and if in SAD’s reasonably exercised discretion, the Generex Buyer Specification Changes are found to be commercially reasonable and feasible, SAD will inform Generex Buyer of any scheduling and/or price adjustments which may result from the Generex Buyer Specification Changes. Prior to implementation of Generex Buyer Specification Changes, the Parties shall negotiate in good faith in an attempt to reach agreement on (a) the new Active Ingredient Price for any Active Ingredient which embodies the Generex Buyer Specification Changes, (b) any amounts to be reimbursed by Generex Buyer to SAD as described in the next sentence of this paragraph, and (c) any other amendments to this Agreement which may be necessitated by the Generex Buyer Specification Changes (i.e., an adjustment to the lead time for purchase ordersPOs). Generex Buyer shall reimburse SAD for the mutually agreed upon reasonable expenses incurred by S AD SAD as a result of the Generex Buyer Specification Changes, including, but not limited to, reimbursing SAD for its mutually agreed validation and development costs, capital expenditure costs and costs for any reasonable inventory of packaging components or other materials maintained by SAD for purposes of this Agreement and consistent with any then-current Forecastthe PO, and rendered unusable as a result of the Generex Buyer Specification Changes. If during the Term, GenerexBuyer, in accordance with this Article 5, causes the amendment of the Active Ingredient Specifications or Packaging Specifications so as to render obsolete reasonable quantities of the Active Ingredient and/or materials and components used to manufacture and package the Active Ingredient pursuant to this Agreement on hand at SAD, Generex Buyer shall purchase from SAD (i) all such obsolete Active Ingredient at the Active Ingredient Prices then in effect, (ii) all work-in-progress of the Active Ingredient at SAD’s actual cost thereof, and (iii) at SAD’s Acquisition Cost, all such obsolete materials and components obtained by SAD pursuant to its normal procurement policies to manufacture quantities of the Active Ingredient pursuant to Generex’ forecasts under Section 6.1the PO. SAD’s normal procurement policies for purposes of the preceding sentence of this Article 5 shall be considered to be quantities of materials and components corresponding to the following six (6) months of Generex’s forecasted Active Ingredient demandPO. For greater certainty, the foregoing provisions of this Article 5 shall not apply in respect of any change in the Active Ingredient Specifications or Packaging Specifications made by SAD other than pursuant to a Generex Buyer request. SAD shall provide Generex Buyer with not less than six three (63) months’ prior written notice of SAD’s implementation of any intended significant change(s) to its manufacturing processes for the Active Ingredient, which might affect the quality of the Active Ingredient (“Change Notice”) (e.g. Any any change in the Active Ingredient Specifications or Packaging Specifications made by SAD other than pursuant to a Generex Buyer request). If a significant change is implemented by SAD and Generex Buyer provides SAD with demonstrable evidence that the utility (i.e. the conditions of being useful as a pharmaceutical product in connection with the manufacture and performance of the Product) of the Active Ingredient is significantly altered in that there is no similar bioequivalence (to Active Ingredient before the significant change) or similar Product specifications when formulated in the final Product formulation (together, “Utility Loss”), the parties shall exert their best commercial efforts to resolve issues related to the Utility Loss in order to continue operating under this Agreement. If the parties cannot reach agreement and resolution regarding Utility Loss Generex Loss, Buyer shall have the option to provide sixty (60) days written notice of termination of this Agreement to SAD.

Specification Changes. Aventis, in its sole discretion, shall have the sole right and authority to make and approve changes in the Specifications. Upon any change in the Active Ingredient Specifications (whether initiated by Aventis or Packaging Specifications requested made in response to a request by Generex (“Generex Specification Changes”Inyx that is agreed to by Aventis), including the addition of new packaging configurations, Generex Aventis shall promptly advise SAD Inyx in writing of any requested Generex Specification Changessuch changes, and SAD Inyx shall promptly advise Generex Aventis as to the feasibility of the Generex Specification Changes, and if in SAD’s reasonably exercised discretion, the Generex Specification Changes are found to be commercially reasonable and feasible, SAD will inform Generex of any scheduling and/or price adjustments which may result from the Generex Specification Changessuch changes. Prior to implementation of Generex Specification Changessuch changes, the Parties shall negotiate in good faith in an attempt to reach agreement on (a) the new Active Ingredient Price price for any Active Ingredient Aventis Products manufactured hereunder by Inyx which embodies the Generex Specification Changessuch changes, (b) any amounts to be reimbursed by Generex Aventis to SAD Inyx as described in the next sentence of this paragraphArticle 5, and (c) any other amendments to this Agreement which may be necessitated by the Generex Specification Changes such changes (i.e., an adjustment to the lead time for purchase orders). Generex Aventis shall reimburse SAD Inyx for the mutually agreed upon reasonable expenses incurred by S AD Inyx as a result of the Generex Specification Changessuch changes, including, but not limited to, reimbursing SAD Inyx for its mutually agreed validation and development costs, capital expenditure costs and costs for any reasonable inventory of packaging components or other materials maintained by SAD for purposes of this Agreement and consistent with any then-current Forecast, and rendered unusable as a result of such changes. Validation and development costs shall be the Generex Specification Changessubject of separate proposals and written agreements between the Parties. If during the Term, GenerexAventis amends the Specifications (whether voluntarily or as required by law, in accordance with this Article 5, causes the amendment of the Active Ingredient Specifications regulation or Packaging Specifications cGMPs) so as to render obsolete reasonable quantities of the Active Ingredient and/or materials and components used to manufacture and package Components for the Active Ingredient pursuant to this Agreement Aventis Products on hand at SADInyx, Generex then Aventis shall purchase from SAD (i) accept the return of all such obsolete Active Ingredient at the Active Ingredient Prices then in effect, and/or Components and (ii) all work-in-progress of the Active Ingredient purchase from Inyx, at SAD’s actual cost thereof, and (iii) at SADInyx’s Acquisition Cost, all such obsolete materials and components Components obtained by SAD Inyx pursuant to its normal procurement policies to manufacture quantities of the Active Ingredient Aventis Products pursuant to GenerexAventis’ forecasts under Section 6.1Article 6. SADInyx’s normal procurement policies for purposes of the preceding sentence of this Article 5 shall be considered to be quantities a three-month’s supply or three Batches, whichever is less, for printed packaging components and a three-month’s supply or three Batches, whichever is less, for all other Components, such amounts being determined in accordance with the forecast provided in Article 6 unless, in respect of materials and components corresponding one or more Components, Aventis has agreed in writing to the following six (6) months of Generex’s forecasted Active Ingredient demanda different supply arrangement. For greater certainty, the foregoing provisions of Any dispute arising in connection with this Article 5 shall not apply be resolved in respect of any change in the Active Ingredient Specifications or Packaging Specifications made by SAD other than pursuant to a Generex request. SAD shall provide Generex with not less than six (6) months’ prior written notice of SAD’s implementation of any intended significant change(s) to its manufacturing processes for the Active Ingredient, which might affect the quality of the Active Ingredient (“Change Notice”) (e.g. Any change in the Active Ingredient Specifications or Packaging Specifications made by SAD other than pursuant to a Generex request). If a significant change implemented by SAD and Generex provides SAD with demonstrable evidence that the utility (i.e. the conditions of being useful as a pharmaceutical product in connection accordance with the manufacture and performance of the Product) of the Active Ingredient is significantly altered Technical Dispute Resolution Procedure set out in that there is no similar bioequivalence (to Active Ingredient before the significant change) or similar Product specifications when formulated in the final Product formulation (together, “Utility Loss”), the parties shall exert their best commercial efforts to resolve issues related to the Utility Loss in order to continue operating under this Agreement. If the parties cannot reach agreement and resolution regarding Utility Loss Generex shall have the option to provide sixty (60) days written notice of termination of this Agreement to SADExhibit D hereto.

Specification Changes. Upon any change in the Active Ingredient Specifications Product Specifications, stability protocols, QC laboratory methods raw material specification or Packaging Specifications requested (whether initiated by Generex (“Generex Specification Changes”Horizon or made in response to a request by sanofi-aventis that is agreed to by Horizon), including the addition of new packaging configurations, Generex new SKUs, new formulations, or a change in either raw materials or Packaging Component supply, Horizon shall promptly advise SAD sanofi-aventis in writing of any requested Generex Specification Changessuch changes, and SAD sanofi-aventis shall promptly advise Generex Horizon as to the feasibility of the Generex Specification Changes, and if in SAD’s reasonably exercised discretion, the Generex Specification Changes are found to be commercially reasonable and feasible, SAD will inform Generex of any scheduling and/or price adjustments which may result from the Generex Specification Changessuch changes. Prior to implementation of Generex Specification Changessuch changes, the Parties shall negotiate in good faith in an attempt to reach agreement on (a) the new Active Ingredient Product Price for any Active Ingredient Product which embodies the Generex Specification Changessuch changes, (b) any amounts to be reimbursed by Generex Horizon to SAD sanofi-aventis as described in the next sentence of this paragraph, and (c) any other amendments to this Agreement which may be necessitated by the Generex Specification Changes such changes (i.e., an adjustment to the lead time for purchase orders). Generex Horizon shall reimburse SAD sanofi-aventis for the mutually agreed upon reasonable expenses incurred by S AD sanofi-aventis as a result of the Generex Specification Changessuch changes, including, but not limited to, reimbursing SAD sanofi-aventis for its mutually agreed validation and development costs, capital expenditure costs and costs, costs for any reasonable inventory of packaging components Packaging Components or other materials maintained by SAD for purposes of this Agreement and consistent with any then-current Forecast, and rendered unusable as a result of the Generex Specification Changessuch changes, and cost of required stability to support a change. If during the Term, Generex, in accordance with this Article 5, causes Term Horizon amends the amendment of the Active Ingredient Product Specifications or Packaging ***Confidential Treatment Requested Specifications (whether voluntarily or as required by law) so as to render obsolete reasonable quantities of the Active Ingredient Ingredient, Excipients and/or materials and components used to manufacture and package Packaging Components for the Active Ingredient pursuant to this Agreement Product on hand at SADsanofi-aventis, Generex Horizon shall purchase from SAD (i) accept the return of all such obsolete Active Ingredient at the Active Ingredient Prices then in effect, and (ii) all workpurchase from sanofi-inaventis, at sanofi-progress of the Active Ingredient at SAD’s actual cost thereof, and (iii) at SAD’s aventis’ Acquisition Cost, all such obsolete materials Excipients and components Packaging Components obtained by SAD sanofi-aventis pursuant to its normal procurement policies to manufacture quantities of the Active Ingredient Product pursuant to Generex’ Horizon forecasts under Section 6.1. SAD’s Sanofi-aventis’ normal procurement policies for purposes of the preceding sentence of this Article 5 shall be considered to be quantities of materials Excipients and components Packaging Components corresponding to the immediately following six (6) […***…] months of GenerexHorizon’s most recent forecasted Active Ingredient Product demand. For greater certainty, the foregoing provisions of this Article 5 shall not apply in respect of any change in the Active Ingredient Specifications or Packaging Specifications made by SAD other than pursuant to a Generex request. SAD shall provide Generex with not less than six (6) months’ prior written notice of SAD’s implementation of any intended significant change(s) to its manufacturing processes for the Active Ingredient, which might affect the quality of the Active Ingredient (“Change Notice”) (e.g. Any change in the Active Ingredient Specifications or Packaging Specifications made by SAD other than pursuant to a Generex request). If a significant change implemented in Specifications is initiated by SAD sanofi-aventis and Generex provides SAD approved by Horizon, any cost associated with demonstrable evidence said change shall be borne by sanofi-aventis. In the event that a change in Specifications is initiated by Horizon or driven by a regulatory or business change, the utility (i.e. the conditions of being useful as a pharmaceutical product in connection costs associated with the manufacture and performance qualification of the Product) change shall be paid by Horizon. The amount of the Active Ingredient is significantly altered in that there is no similar bioequivalence change shall be reasonable and customary and subject to written approval by Horizon, such approval not to be unreasonably withheld. Sanofi-aventis, with written agreement and approval from Horizon, will be responsible for the appropriate (to Active Ingredient before the significant changecGMP) or similar Product specifications when formulated in the final Product formulation (together, “Utility Loss”), the parties shall exert their best commercial efforts to resolve issues related to the Utility Loss in order to continue operating destruction of any materials covered under this Agreement. If Article 5, and sanofi-aventis shall be reimbursed by Horizon at the parties cannot reach agreement reasonable and resolution regarding Utility Loss Generex shall have the option to provide sixty (60) days written notice of termination of this Agreement to SADcustomary approved rate.

Specification Changes. Upon any Specifications may be revised from time to time as mutually agreed in writing between the parties (either by execution of an amended BUSA Attachment A that references the new revision level or other writings of the parties). Supplier shall not unreasonably withhold approval to Specifications changes proposed in writing by Medtronic (each change in the Active Ingredient Specifications or Packaging Specifications requested by Generex (a “Generex Specification ChangesPCN”), including the addition of new packaging configurations, Generex shall promptly advise SAD in writing of any requested Generex Specification Changes, and SAD shall promptly advise Generex as . Supplier will use commercially reasonable efforts to evaluate the feasibility of the Generex Specification Changes, PCN requested by Medtronic within ten (10) Business Days of receipt and if respond to Medtronic in SAD’s reasonably exercised discretion, writing with the Generex Specification Changes are found to be commercially reasonable and feasible, SAD will inform Generex of any scheduling and/or price adjustments which may result from the Generex Specification Changes. Prior to implementation of Generex Specification Changes, the Parties shall negotiate in good faith in an attempt to reach agreement on (a) the new Active Ingredient Price for any Active Ingredient which embodies the Generex Specification Changes, (b) any amounts to be reimbursed by Generex to SAD as described in the next sentence of this paragraph, and (c) any other amendments to this Agreement which may be necessitated by the Generex Specification Changes (i.e., an adjustment to the lead time for purchase orders). Generex shall reimburse SAD for the mutually agreed upon reasonable expenses incurred by S AD as a result potential impact of the Generex Specification ChangesPCN on current on-hand or on-order component inventory, including, but not limited to, reimbursing SAD for its mutually agreed validation and development costs, capital expenditure costs and costs for any reasonable inventory of packaging components or other materials maintained by SAD for purposes of this Agreement and consistent with any then-current Forecast, and rendered unusable as a result of the Generex Specification Changes. If during the Term, Generex, in accordance with this Article 5, causes the amendment of the Active Ingredient Specifications or Packaging Specifications so as to render obsolete reasonable quantities of the Active Ingredient and/or materials and components used to manufacture and package the Active Ingredient pursuant to this Agreement on hand at SAD, Generex shall purchase from SAD (i) all such obsolete Active Ingredient at the Active Ingredient Prices then in effect, (ii) all work-in-progress Products (“WIP”), finished goods Products, and/or the delivery schedule. In addition to the written response provided above, Supplier will use commercially reasonable efforts to respond to Medtronic within ten (10) business days with a written evaluation of the Active Ingredient at SAD’s actual PCN including: (i) engineering time to implement the PCN, (ii) the cost thereofto modify tools or test fixtures or similar non-recurring expenses, (iii) the quantity of components Supplier has on hand and/or on order with its suppliers related that can no longer be used due to the PCN, (iv) the cost to rework WIP (if applicable) and any impacts to Product price resulting from the PCN, (v) the expected effect on the delivery schedule to include (if applicable) the effect on all in-process work (e.g., re-workable, repairable, etc.), and (iiivi) the manner in which the PCN will be implemented by Supplier. Supplier will not proceed to implement the PCN until Medtronic has approved the charges and Supplier actions described in the Supplier evaluation that is provided to Medtronic. The price for a Product covered by a revised Specification shall remain the same as before the revision, unless the revisions will result in an increase or decrease in costs at SAD’s Acquisition Cost, all such obsolete materials and components obtained by SAD pursuant to its normal procurement policies to manufacture quantities least +/- 5% of any cost element of the Active Ingredient pursuant to Generex’ forecasts under Section 6.1. SAD’s normal procurement policies for purposes applicable quote (e.g. materials, components, labor, test); in that case, the Supplier will notify Medtronic of the preceding sentence of this Article 5 shall be considered to be quantities of materials and components corresponding to the following six (6) months of Generex’s forecasted Active Ingredient demand. For greater certainty, the foregoing provisions of this Article 5 shall not apply in respect of any anticipated change in the Active Ingredient Specifications or Packaging Specifications made by SAD other than pursuant to a Generex request. SAD shall provide Generex with not less than six (6) months’ prior written notice of SAD’s implementation of any intended significant change(s) to its manufacturing processes for the Active Ingredientcosts, which might affect the quality of the Active Ingredient (“Change Notice”) (e.g. Any change in the Active Ingredient Specifications or Packaging Specifications made by SAD other than pursuant to a Generex request). If a significant change implemented by SAD and Generex provides SAD with demonstrable evidence that the utility (i.e. the conditions of being useful as a pharmaceutical product in connection with the manufacture and performance of the Product) of the Active Ingredient is significantly altered in that there is no similar bioequivalence (to Active Ingredient before the significant change) or similar Product specifications when formulated in the final Product formulation (together, “Utility Loss”), the parties shall exert their best commercial efforts to resolve issues related to will negotiate a new price (based on the Utility Loss increase or decrease in order to continue operating under this Agreement. If costs) and the parties cannot reach agreement and resolution regarding Utility Loss Generex shall have the option to provide sixty (60) days written notice of termination of this Agreement to SADBUSA Attachment A will be amended accordingly.

Specification Changes. Upon any change in the Active Ingredient Specifications Product Specifications, stability protocols, QC laboratory methods raw material specification or Packaging Specifications requested (whether initiated by Generex (“Generex Specification Changes”Horizon or made in response to a request by sanofi-aventis that is agreed to by Horizon), including the addition of new packaging configurations, Generex new SKUs, new formulations, or a change in either raw materials or Packaging Component supply, Horizon shall promptly advise SAD sanofi-aventis in writing of any requested Generex Specification Changessuch changes, and SAD sanofi-aventis shall promptly advise Generex Horizon as to the feasibility of the Generex Specification Changes, and if in SAD’s reasonably exercised discretion, the Generex Specification Changes are found to be commercially reasonable and feasible, SAD will inform Generex of any scheduling and/or price adjustments which may result from the Generex Specification Changessuch changes. Prior to implementation of Generex Specification Changessuch changes, the Parties shall negotiate in good faith in an attempt to reach agreement on (a) the new Active Ingredient Product Price for any Active Ingredient Product which embodies the Generex Specification Changessuch changes, (b) any amounts to be reimbursed by Generex Horizon to SAD sanofi-aventis as described in the next sentence of this paragraph, and (c) any other amendments to this Agreement which may be necessitated by the Generex Specification Changes such changes (i.e., an adjustment to the lead time for purchase orders). Generex Horizon shall reimburse SAD sanofi-aventis for the mutually agreed upon reasonable expenses incurred by S AD sanofi-aventis as a result of the Generex Specification Changessuch changes, including, but not limited to, reimbursing SAD sanofi-aventis for its mutually agreed validation and development costs, capital expenditure costs and costs, costs for any reasonable inventory of packaging components Packaging Components or other materials maintained by SAD for purposes of this Agreement and consistent with any then-current Forecast, and rendered unusable as a result of the Generex Specification Changessuch changes, and cost of required stability to support a change. If during the Term, Generex, in accordance with this Article 5, causes Term Horizon amends the amendment of the Active Ingredient Product Specifications or Packaging ***Confidential Treatment Requested MANUFACTURING AND SUPPLY AGREEMENT PAGE 7 Specifications (whether voluntarily or as required by law) so as to render obsolete reasonable quantities of the Active Ingredient Ingredient, Excipients and/or materials and components used to manufacture and package Packaging Components for the Active Ingredient pursuant to this Agreement Product on hand at SADsanofi-aventis, Generex Horizon shall purchase from SAD (i) accept the return of all such obsolete Active Ingredient at the Active Ingredient Prices then in effect, and (ii) all workpurchase from sanofi-inaventis, at sanofi-progress of the Active Ingredient at SAD’s actual cost thereof, and (iii) at SAD’s aventis’ Acquisition Cost, all such obsolete materials Excipients and components Packaging Components obtained by SAD sanofi-aventis pursuant to its normal procurement policies to manufacture quantities of the Active Ingredient Product pursuant to Generex’ Horizon forecasts under Section 6.1. SAD’s Sanofi-aventis’ normal procurement policies for purposes of the preceding sentence of this Article 5 shall be considered to be quantities of materials Excipients and components Packaging Components corresponding to the immediately following six (6) […***…] months of GenerexHorizon’s most recent forecasted Active Ingredient Product demand. For greater certainty, the foregoing provisions of this Article 5 shall not apply in respect of any change in the Active Ingredient Specifications or Packaging Specifications made by SAD other than pursuant to a Generex request. SAD shall provide Generex with not less than six (6) months’ prior written notice of SAD’s implementation of any intended significant change(s) to its manufacturing processes for the Active Ingredient, which might affect the quality of the Active Ingredient (“Change Notice”) (e.g. Any change in the Active Ingredient Specifications or Packaging Specifications made by SAD other than pursuant to a Generex request). If a significant change implemented in Specifications is initiated by SAD sanofi-aventis and Generex provides SAD approved by Horizon, any cost associated with demonstrable evidence said change shall be borne by sanofi-aventis. In the event that a change in Specifications is initiated by Horizon or driven by a regulatory or business change, the utility (i.e. the conditions of being useful as a pharmaceutical product in connection costs associated with the manufacture and performance qualification of the Product) change shall be paid by Horizon. The amount of the Active Ingredient is significantly altered in that there is no similar bioequivalence change shall be reasonable and customary and subject to written approval by Horizon, such approval not to be unreasonably withheld. Sanofi-aventis, with written agreement and approval from Horizon, will be responsible for the appropriate (to Active Ingredient before the significant changecGMP) or similar Product specifications when formulated in the final Product formulation (together, “Utility Loss”), the parties shall exert their best commercial efforts to resolve issues related to the Utility Loss in order to continue operating destruction of any materials covered under this Agreement. If Article 5, and sanofi-aventis shall be reimbursed by Horizon at the parties cannot reach agreement reasonable and resolution regarding Utility Loss Generex shall have the option to provide sixty (60) days written notice of termination of this Agreement to SADcustomary approved rate.