Common use of Supply Price Clause in Contracts

Supply Price. 8.15.1. AstraZeneca shall charge Impax on a per unit basis a supply price for each Supplied Product mode of administration and dosage strength (the “Supply Price”), which Supply Price initially shall be the applicable amount set forth in Schedule 8.15. 1. [***]. During the Supply Term, AstraZeneca shall use reasonable efforts, consistent with the timing of its internal budget cycle, (i) to notify Impax on or before [***] of each Calendar Year for budget planning purposes of a preliminary Supply Price (including the Selected Manufacturing Costs contained in such Supply Price) for each Supplied Product mode of administration and dosage strength for the following Calendar Year, and (ii) to promptly notify Impax (in no event later than [***] of each Calendar Year) of the Supply Price (including the Selected Manufacturing Costs contained in such Supply Price) for each Supplied Product mode of administration and dosage strength for the following Calendar Year. Concurrently with the notice of each Supply Price increase or decrease (whether preliminary or final), AstraZeneca shall provide reasonable evidence to Impax of [***]in the Selected Manufacturing Costs for each Supplied Product mode of administration and dosage strength. (i) If the Selected Manufacturing Costs for any dosage strength of Zomig Tablets increase on a per unit basis by more than [***] in any Calendar Year compared to the immediately preceding Calendar Year (the amount of such excess Selected Manufacturing Cost increase above [***], the “Royalty Tablet Offset Amount”), then beginning on the date of such increase, the royalties payable by Impax pursuant to Section 7.2 on Zomig Tablets for each Calendar Quarter in the applicable Calendar Year shall be reduced by the Royalty Tablet Offset Amount attributable to those units of Zomig Tablets purchased by Impax at the applicable Supply Price during such Calendar Quarter; provided that the Royalty Tablet Offset Amount shall not exceed [***] on a per unit basis of the immediately preceding Calendar Year’s Selected Manufacturing Costs for such Zomig Tablets. If the Selected Manufacturing Costs for any formulation or dosage of Zomig Tablets increases by more than [***] on a per unit basis in any Calendar Year compared to the immediately preceding Calendar Year, then Impax shall have the right to terminate this Agreement as provided in Section 14.3.3. (ii) If the Selected Manufacturing Costs for any dosage strength of Zomig-ZMT increase on a per unit basis by more than [***] in any Calendar Year compared to the immediately preceding Calendar Year (the amount of such excess Selected Manufacturing Cost increase above [***], the “Royalty ZMT Offset Amount”), then beginning on the date of such increase, the royalties payable by Impax pursuant to Section 7.2 on Zomig-ZMT for each Calendar Quarter in the applicable Calendar Year shall be reduced by the Royalty ZMT Offset Amount attributable to those units of Zomig-ZMT purchased by Impax at the applicable Supply Price during such Calendar Quarter; provided that the Royalty ZMT Offset Amount shall not exceed more than [***] on a per unit basis of the immediately preceding Calendar Year’s Selected Manufacturing Costs for such Zomig-ZMT. If the Selected Manufacturing Costs for any formulation or dosage of Zomig-ZMT increases by more than [***] on a per unit basis in any Calendar Year compared to the immediately preceding Calendar Year, then Impax shall have the right to terminate this Agreement as provided in Section 14.3.3. (iii) If the Selected Manufacturing Costs for any dosage strength of Zomig Nasal Spray increase on a per unit basis by more than [***] in any Calendar Year compared to the immediately preceding Calendar Year (the amount of such excess Selected Manufacturing Cost increase above [***], the “Royalty Nasal Offset Amount”), then beginning on the date of such increase, the royalties payable by Impax pursuant to Section 7.2 on Zomig Nasal Spray for each Calendar Quarter in the applicable Calendar Year shall be reduced by the Royalty Nasal Offset Amount attributable to those units of Zomig Nasal Spray purchased by Impax at the applicable Supply Price during such Calendar Quarter; provided that the Royalty Nasal Offset Amount shall not exceed more than [***] on a per unit basis of the immediately preceding Calendar Year’s Selected Manufacturing Costs for such Zomig Nasal Spray. If the Selected Manufacturing Costs for any formulation or dosage of Zomig Nasal Spray increases by more than [***] on a per unit basis in any Calendar Year compared to the immediately preceding Calendar Year, then Impax shall have the right to terminate this Agreement as provided in Section 14.3.3. (iv) For clarity, (a) clauses (i) through (iii) also apply with respect to Impax Generic Versions of the applicable Existing Products, and (b) the calculation of any Royalty Tablet Offset Amount, Royalty ZMT Offset Amount and Royalty Nasal Offset Amount shall apply on a Calendar Year-by-Calendar Year basis with the amount of any increase (or decrease) calculated solely on the basis of the immediately preceding Calendar Year. (v) This Section 8.15 shall be subject to Section 7.2.4 and 7.2.5. (vi) An example calculation with respect to clauses (i), (ii) and (iii) is set forth in Schedule 8.15.1(vi), which example is provided solely by way of example and without limitation. In the event of any conflict between the terms of Schedule 8.15.1(vi) and this Agreement, this Agreement shall control. 8.15.2. AstraZeneca shall invoice Impax for the applicable Supply Price together with, or promptly after, each delivery to Impax of conforming supplies of the Supplied Products ordered by Impax. Impax shall pay in full each such invoice in accordance with Section 7.4 within [***] of the invoice date. 8.15.3. AstraZeneca has provided Impax with AstraZeneca’s Supply Prices for each Supplied Product for [***] for each Supplied Product for [***] and those Supply Prices shall remain in effect until [***]. AstraZeneca shall provide to Impax AstraZeneca’s Supply Prices for the following Calendar Years based upon [***] as provided in Section 8.15.1. Impax [***] may retain an Independent Auditor that is approved by AstraZeneca to conduct an audit of the basis for any Supply Price increase or decrease for a given Calendar Year, which audit shall occur no more than [***] with respect to each Calendar Year and shall be conducted prior to [***] of the Calendar Year in which such increase or decrease will be in effect. Any such approval with respect to the selection of an independent auditor shall not be unreasonably withheld, conditioned or delayed, and AstraZeneca shall respond to such request for approval pursuant to this Section 8.15.3 within [***]. AstraZeneca shall cooperate with such Independent Auditor’s investigation, and the results of any audit under this Section 8.15.3 shall (i) disclose only whether any increase or decrease in [***] under this Agreement is correct or incorrect and the amount of any discrepancy and (ii) be made available to both Parties. Prior to and as a condition to the Independent Auditor conducting any audit, Impax shall ensure that the Independent Auditor has entered into a confidentiality agreement with obligations no less restrictive than those obligations set forth in Article 11. In no event may the Independent Auditor disclose to Impax any documentation, calculations or information provided to the Independent Auditor by AstraZeneca that has not been approved by AstraZeneca, such approval not to be unreasonably withheld, conditioned or delayed, and AstraZeneca shall respond to such request for approval pursuant to this Section 8.15.3 within [***]. Except as provided below, the cost of this audit shall be borne by Impax, unless the audit reveals a variance in the aggregate (taking account of all Supplied Products) of more than [***] from the reported Supply Price increase(s) or decrease(s) and the variance benefitted AstraZeneca, in which case AstraZeneca shall bear the cost of the audit. Unless disputed pursuant to Section 8.15.4, if such audit concludes for the period of time following the enactment of the applicable Supply Price increase or decrease that excess payments were made by Impax, AstraZeneca shall reimburse such excess payments with interest from the date originally due as provided in Section 7.6 within [***] after the date on which such audit is completed by Impax. 8.15.4. In the event of a dispute with respect to any audit under Section 8.15.3, AstraZeneca and Impax shall work in good faith to resolve the disagreement. If the Parties are unable to reach a mutually acceptable resolution of any such dispute within [***], the dispute shall be submitted for resolution to an Arbitrator. The decision of the Arbitrator shall be final and the costs of such arbitration as well as the initial audit shall be borne between the Parties in such manner as the Arbitrator shall determine. Not later than [***] after such decision and in accordance with such decision, the audited Party shall pay the additional amounts that were not paid, with interest from the date originally due as provided in Section 7.6, or the auditing Party shall reimburse the excess payments that were paid, as applicable.

Appears in 2 contracts

Samples: Distribution, License, Development and Supply Agreement (Impax Laboratories Inc), Distribution, License, Development and Supply Agreement (Impax Laboratories Inc)

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Supply Price. 8.15.1(a) Corixa agrees to provide Rhein with quantities of Licensed Adjuvant reasonably required by Rhein for use in Licensed Product. AstraZeneca shall charge Impax Corixa will provide clinical and commercial grade Licensed Adjuvant on a per unit bulk basis a supply price for each Supplied Product mode of administration and dosage strength (the “Supply Price”)incorporation into Licensed Product, which Supply Price initially shall be the applicable amount set forth in Schedule 8.15. 1. [***]. During the Supply Term, AstraZeneca shall use reasonable efforts, consistent with the timing of its internal budget cycle, (i) to notify Impax on or before [***] of each Calendar Year for budget planning purposes of a preliminary Supply Price (including the Selected Manufacturing Costs contained in such Supply Price) for each Supplied Product mode of administration and dosage strength for at the following Calendar Year, and (ii) to promptly notify Impax (in no event later than [***] of each Calendar Year) of the Supply Price (including the Selected Manufacturing Costs contained in such Supply Price) for each Supplied Product mode of administration and dosage strength for the following Calendar Year. Concurrently with the notice of each Supply Price increase or decrease (whether preliminary or final), AstraZeneca shall provide reasonable evidence to Impax of [***]in the Selected Manufacturing Costs for each Supplied Product mode of administration and dosage strength.prices: (i) If the Selected Manufacturing Costs For pre-clinical and clinical grade (cGMP) Licensed Adjuvant, [ * ] per milligram at [ * ] for any dosage strength of Zomig Tablets increase on a Licensed Adjuvant in aqueous formulation and [ * ] per unit basis by more milligram for lyophilized formulation and reference standard; (ii) For commercial grade (cGMP) Licensed Adjuvant, lyophilized formulation, [ * ] per gram for orders equal to or less than [***[ * ] in any Calendar Year compared grams per year; [ * ] per gram for orders greater than [ * ] grams and less than [ * ] grams per year; and [ * ] per gram for orders equal to the immediately preceding Calendar Year (the amount of such excess Selected Manufacturing Cost increase above [***]or greater than [ * ] grams per year; In all cases, the “Royalty Tablet Offset Amount”), then beginning on the date foregoing costs shall be plus shipping and insurance. (b) If Corixa’s manufacturing costs increase due to Rhein’s requirements for new or modified Specifications or formulations of such increaseLicensed Adjuvant, the royalties payable by Impax pursuant to Section 7.2 on Zomig Tablets for each Calendar Quarter parties shall negotiate in the applicable Calendar Year shall be reduced by the Royalty Tablet Offset Amount attributable to those units of Zomig Tablets purchased by Impax at the applicable Supply Price during such Calendar Quarter; provided that the Royalty Tablet Offset Amount good faith a new pricing system. Corixa shall not exceed [***] on be obligated to manufacture in accordance with any such new or modified Specifications or formulations until the parties have agreed to a per unit basis of the immediately preceding Calendar Year’s Selected Manufacturing Costs for such Zomig Tablets. If the Selected Manufacturing Costs for any formulation or dosage of Zomig Tablets increases by more than [***] on a per unit basis in any Calendar Year compared to the immediately preceding Calendar Year, then Impax price. (c) Corixa shall have the right as from the first anniversary after the first commercial supply of Licensed Adjuvant to terminate this Agreement as provided annually increase its transfer prices in Section 14.3.3. an amount not to exceed the increase in the United States Consumer Price Index for all Urban Consumers (ii“CPI”) If the Selected Manufacturing Costs for any dosage strength of Zomig-ZMT increase on a per unit basis by more than [***] in any Calendar Year compared to the immediately preceding Calendar Year twelve (12) month period over the amount index value at the beginning of such excess Selected Manufacturing Cost increase above [***]period, the “Royalty ZMT Offset Amount”), then beginning on the date of such increase, the royalties payable by Impax pursuant to Section 7.2 on Zomig-ZMT for each Calendar Quarter in the applicable Calendar Year shall be reduced by the Royalty ZMT Offset Amount attributable to those units of Zomig-ZMT purchased by Impax at the applicable Supply Price during such Calendar Quarter; provided that the Royalty ZMT Offset Amount permissible percentage increase in the [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. transfer price on a given adjustment date shall not exceed more than [***] on a per unit basis of three percent (3%) unless the increase in the CPI for the immediately preceding Calendar Year’s Selected Manufacturing Costs for such Zomig-ZMT. If the Selected Manufacturing Costs for any formulation or dosage of Zomig-ZMT increases by more than [***] on a per unit basis in any Calendar Year compared to the immediately preceding Calendar Year, then Impax shall have the right to terminate this Agreement as provided in Section 14.3.3. twelve (iii12) If the Selected Manufacturing Costs for any dosage strength of Zomig Nasal Spray increase on a per unit basis by more than [***] in any Calendar Year compared to the immediately preceding Calendar Year month period exceeds ten percent (the amount of such excess Selected Manufacturing Cost increase above [***], the “Royalty Nasal Offset Amount”10%), then beginning on the date of such increase, the royalties payable by Impax pursuant to Section 7.2 on Zomig Nasal Spray for each Calendar Quarter in the applicable Calendar Year shall be reduced by the Royalty Nasal Offset Amount attributable to those units of Zomig Nasal Spray purchased by Impax at the applicable Supply Price during such Calendar Quarter; provided that the Royalty Nasal Offset Amount shall not exceed more than [***] on a per unit basis of the immediately preceding Calendar Year’s Selected Manufacturing Costs for such Zomig Nasal Spray. If the Selected Manufacturing Costs for any formulation or dosage of Zomig Nasal Spray increases by more than [***] on a per unit basis in any Calendar Year compared to the immediately preceding Calendar Year, then Impax shall have the right to terminate this Agreement as provided in Section 14.3.3. (iv) For clarity, (a) clauses (i) through (iii) also apply with respect to Impax Generic Versions of the applicable Existing Products, and (b) the calculation of any Royalty Tablet Offset Amount, Royalty ZMT Offset Amount and Royalty Nasal Offset Amount shall apply on a Calendar Year-by-Calendar Year basis with the amount of any increase (or decrease) calculated solely on the basis of the immediately preceding Calendar Year. (v) This Section 8.15 shall be subject to Section 7.2.4 and 7.2.5. (vi) An example calculation with respect to clauses (i), (ii) and (iii) is set forth in Schedule 8.15.1(vi), which example is provided solely by way of example and without limitation. In the event of any conflict between the terms of Schedule 8.15.1(vi) and this Agreement, this Agreement shall control. 8.15.2. AstraZeneca shall invoice Impax for the applicable Supply Price together with, or promptly after, each delivery to Impax of conforming supplies of the Supplied Products ordered by Impax. Impax shall pay in full each such invoice in accordance with Section 7.4 within [***] of the invoice date. 8.15.3. AstraZeneca has provided Impax with AstraZeneca’s Supply Prices for each Supplied Product for [***] for each Supplied Product for [***] and those Supply Prices shall remain in effect until [***]. AstraZeneca shall provide to Impax AstraZeneca’s Supply Prices for the following Calendar Years based upon [***] as provided in Section 8.15.1. Impax [***] may retain an Independent Auditor that is approved by AstraZeneca to conduct an audit of the basis for any Supply Price increase or decrease for a given Calendar Year, which audit shall occur no more than [***] with respect to each Calendar Year and shall be conducted prior to [***] of the Calendar Year in which such increase or decrease will be in effect. Any such approval with respect to the selection of an independent auditor shall not be unreasonably withheld, conditioned or delayed, and AstraZeneca shall respond to such request for approval pursuant to this Section 8.15.3 within [***]. AstraZeneca shall cooperate with such Independent Auditor’s investigation, and the results of any audit under this Section 8.15.3 shall (i) disclose only whether any increase or decrease in [***] under this Agreement is correct or incorrect and the amount of any discrepancy and (ii) be made available to both Parties. Prior to and as a condition to the Independent Auditor conducting any audit, Impax shall ensure that the Independent Auditor has entered into a confidentiality agreement with obligations no less restrictive than those obligations set forth in Article 11. In no event may the Independent Auditor disclose to Impax any documentation, calculations or information provided to the Independent Auditor by AstraZeneca that has not been approved by AstraZeneca, such approval not to be unreasonably withheld, conditioned or delayed, and AstraZeneca shall respond to such request for approval pursuant to this Section 8.15.3 within [***]. Except as provided below, the cost of this audit shall be borne by Impax, unless the audit reveals a variance in the aggregate (taking account of all Supplied Products) of more than [***] from the reported Supply Price increase(s) or decrease(s) and the variance benefitted AstraZeneca, in which case AstraZeneca shall bear for each percent the cost of the audit. Unless disputed pursuant to Section 8.15.4, if CPI for such audit concludes for the period of time following the enactment of the applicable Supply Price increase or decrease that excess payments were made by Impax, AstraZeneca shall reimburse such excess payments with interest from the date originally due as provided in Section 7.6 within [***] after the date on which such audit is completed by Impax. 8.15.4. In the event of a dispute with respect to any audit under Section 8.15.3, AstraZeneca and Impax shall work in good faith to resolve the disagreement. If the Parties are unable to reach a mutually acceptable resolution of any such dispute within [***], the dispute over ten percent (10%) one additional percent (1%) shall be submitted for resolution added to an Arbitrator. The decision of the Arbitrator shall be final and the costs of such arbitration as well as the initial audit shall be borne between the Parties in such manner as the Arbitrator shall determine. Not later than [***] after such decision and in accordance with such decision, the audited Party shall pay the additional amounts that were not paid, with interest from the date originally due as provided in Section 7.6, or the auditing Party shall reimburse the excess payments that were paid, as applicablethree percent (3%) cap.

Appears in 1 contract

Samples: License and Supply Agreement (Dynavax Technologies Corp)

Supply Price. 8.15.1. AstraZeneca shall charge Impax on a per unit basis a The supply price for each Supplied all Bulk Drug Product mode of administration and dosage strength supplied during the Supply Term by Indevus under this Agreement (the “Supply Price”) shall equal the sum of (a) Indevus’ Manufacturing Costs, plus (b) [*] of Bulk Drug Product purchased and used for commercial sales of Product (the “Manufacturing Payment”), which subject to the following: 5.4.1 During the Initial Supply Term, except as otherwise set forth herein, the portion of the Supply Price initially allocated to Indevus’ Manufacturing Costs shall not exceed [*] of Bulk Drug Product (the “Manufacturing Costs Cap”). 5.4.2 During any Renewal Supply Term, the Supply Price shall be calculated as follows: (a) During any portion of any Renewal Supply Term that expires on or prior to the applicable expiration of the Manufacturing Payment Term in which Indevus’ Manufacturing Costs exceed the Manufacturing Costs Cap, the Supply Price shall equal the sum of: (i) Indevus’ Manufacturing Costs (which shall in this case not be subject to the Manufacturing Costs Cap) plus (ii) the Manufacturing Payment, provided that the Manufacturing Payment shall be reduced by the amount by which Indevus’ Manufacturing Costs exceed the Manufacturing Costs Cap. If the Manufacturing Payment would be reduced to zero, Xxxxxx shall have the right to appoint a second source supplier of Bulk Drug Product, provided, however, that in such event, Xxxxxx shall continue to remain liable for any outstanding Binding Portion of a Forecast or Purchase Order. If any portion of such Renewal Supply Term occurs prior to [*], the provisions of Section 3.7(b)(ii)(E) of the Xxxxxx License, as amended by the Amendment and Agreement, shall also be applicable. For example, if during any portion of any Renewal Supply Term that expires on or prior to the expiration of the Manufacturing Payment Term, Indevus’ Manufacturing Costs equal [*] of Bulk Drug Product, the Manufacturing Payment will be reduced by [*] and, accordingly, the Supply Price will equal [*] (Indevus’ Manufacturing Costs of [*] plus the reduced Manufacturing Payment of [*] If such period is prior to [*], then the Additional Payment (as defined in the License Agreement, as amended by the Amendment and Agreement), shall also be reduced by [*] (b) During any portion of any Renewal Supply Term that commences after the expiration of the Manufacturing Payment Term, the Supply Price for all Bulk Drug Product supplied by Indevus under this Agreement shall equal Indevus’ Manufacturing Costs, and the Manufacturing Costs Cap shall not be applicable. If Indevus’ Manufacturing Costs exceed [*] of Bulk Drug Product (subject to adjustment as set forth in Schedule 8.15the next paragraph), Xxxxxx shall have the right to appoint a second source supplier of Bulk Drug Product, provided, however, that in such event, Xxxxxx shall continue to remain liable for any outstanding Binding Portion of a Forecast or Purchase Order. The adjustment applicable to this Section 5.4.2(b) shall be calculated based on: (i) with respect to [*] the average of: (A) the number obtained by (i) dividing the consumer price index (“Verbraucherindex” 2000=100) as available on the German Federal Statistics Office (“Statistisches Bundesamt Deutschlands”) website at xxxx://xxx.xxxxxxxx.xx/indicators/d/pre110ad.htm (the “Website”) with respect to the month most recently reported on the Website on the date of such inflation adjustment by (ii) the same index with respect to the most recent month reported on the Website for September 2011, multiplied by (iii) [*] and (B) the increase in Indevus’ Manufacturing Costs from September 2011 until the date of any calculation required by this Section 5.4.2(b); and (ii) with respect to [*] the average of (A) the number obtained by (i) dividing the consumer price index (“Verbraucherindex” 2000=100) as available on the German Federal Statistics Office (“Statistisches Bundesamt Deutschlands”) website at xxxx://xxx.xxxxxxxx.xx/indicators/d/pre110ad.htm (the “Website”) with respect to the month most recently reported on the Website on the date of such inflation adjustment by (ii) the same index with respect to the most recent month reported on the Website for [*], multiplied by (iii) [*]and (B) the increase in Indevus’ Manufacturing Costs from [*] until the date of any calculation required by this Section 5.4.2(b). 1(iii) The same adjustment shall be made annually and shall apply as to each new one-year period during any Renewal Supply Term commencing after the expiration of the Manufacturing Payment Term. [***]. During the Supply TermAn example of this adjustment, AstraZeneca shall for illustrative purposes only, is set forth on Schedule 5.4.2(b). 5.4.3 Indevus will use commercially reasonable efforts, consistent with its agreements with Third Party manufacturers, to achieve production, volume and other efficiencies in the timing manufacturing of its internal budget cyclethe Bulk Drug Product which, to the extent resulting in a reduction in Indevus’ Manufacturing Costs, shall result in a corresponding reduction in the portion of the Supply Price allocated to Indevus’ Manufacturing Costs. 5.4.4 With respect to Bulk Drug Product used in the Xxxxxx Territory for Samples, such Bulk Drug Product (a) will not be subject to the Manufacturing Payment, and (b) will be provided to Xxxxxx for a supply price equal to Indevus’ Manufacturing Costs; provided, however, that during each year of the Initial Supply Term, the Manufacturing Costs Cap shall be applicable to quantities of Bulk Drug Product used as Samples during that year that are less than ten percent (10%) of Xxxxxx’ aggregate annual quantities of Bulk Drug Product purchased for such year hereunder. Any quantities of Bulk Drug Product used as Samples exceeding such amount shall not be subject to the Manufacturing Costs Cap. 5.4.5 With respect to Bulk Drug Product that are, in accordance with Xxxxxx’ forecasts and Purchase Orders as provided herein, requested to be marked with a designation other than the SANCTURA XR designation (“Xxxxxx Marked Capsules”), Xxxxxx shall, in addition to the Supply Price (as adjusted in accordance with Section 5.4.2), be responsible for and shall pay Indevus within thirty (30) days after being invoiced, (a) the difference between (i) to notify Impax on or before [***] the amount of each Calendar Year for budget planning purposes of a preliminary Supply Price (including the Selected Indevus’ Manufacturing Costs contained in such Supply Price) for each Supplied Product mode that are associated with the production of administration and dosage strength for the following Calendar YearXxxxxx Marked Capsules, and (ii) to promptly notify Impax (in no event later than [***] of each Calendar Year) of the Supply Price (including the Selected Manufacturing Costs contained in such Supply Price) for each Supplied Product mode of administration and dosage strength for the following Calendar Year. Concurrently with the notice of each Supply Price increase or decrease (whether preliminary or final), AstraZeneca shall provide reasonable evidence to Impax of [***]in the Selected Manufacturing Costs for each Supplied Product mode of administration and dosage strength. (i) If the Selected Manufacturing Costs for any dosage strength of Zomig Tablets increase on a per unit basis by more than [***] in any Calendar Year compared to the immediately preceding Calendar Year (the amount of such excess Selected Manufacturing Cost increase above [***], the “Royalty Tablet Offset Amount”), then beginning on the date of such increase, the royalties payable by Impax pursuant to Section 7.2 on Zomig Tablets for each Calendar Quarter in the applicable Calendar Year shall be reduced by the Royalty Tablet Offset Amount attributable to those units of Zomig Tablets purchased by Impax at the applicable Supply Price during such Calendar Quarter; provided that the Royalty Tablet Offset Amount shall not exceed [***] on a per unit basis of the immediately preceding Calendar Year’s Selected Indevus’ Manufacturing Costs for such Zomig Tablets. If that would have been associated with the Selected Manufacturing Costs for any formulation or dosage production of Zomig Tablets increases by more than [***] on a per unit basis in any Calendar Year compared to Bulk Drug Product capsules marked with the immediately preceding Calendar Year, then Impax shall have the right to terminate this Agreement as provided in Section 14.3.3. (ii) If the Selected Manufacturing Costs for any dosage strength of Zomig-ZMT increase on a per unit basis by more than [***] in any Calendar Year compared to the immediately preceding Calendar Year (the amount of such excess Selected Manufacturing Cost increase above [***], the “Royalty ZMT Offset Amount”), then beginning on the date of such increase, the royalties payable by Impax pursuant to Section 7.2 on Zomig-ZMT for each Calendar Quarter in the applicable Calendar Year shall be reduced by the Royalty ZMT Offset Amount attributable to those units of Zomig-ZMT purchased by Impax at the applicable Supply Price during such Calendar Quarter; provided that the Royalty ZMT Offset Amount shall not exceed more than [***] on a per unit basis of the immediately preceding Calendar Year’s Selected Manufacturing Costs for such Zomig-ZMT. If the Selected Manufacturing Costs for any formulation or dosage of Zomig-ZMT increases by more than [***] on a per unit basis in any Calendar Year compared to the immediately preceding Calendar Year, then Impax shall have the right to terminate this Agreement as provided in Section 14.3.3. (iii) If the Selected Manufacturing Costs for any dosage strength of Zomig Nasal Spray increase on a per unit basis by more than [***] in any Calendar Year compared to the immediately preceding Calendar Year (the amount of such excess Selected Manufacturing Cost increase above [***], the “Royalty Nasal Offset Amount”), then beginning on the date of such increase, the royalties payable by Impax pursuant to Section 7.2 on Zomig Nasal Spray for each Calendar Quarter in the applicable Calendar Year shall be reduced by the Royalty Nasal Offset Amount attributable to those units of Zomig Nasal Spray purchased by Impax at the applicable Supply Price during such Calendar Quarter; provided that the Royalty Nasal Offset Amount shall not exceed more than [***] on a per unit basis of the immediately preceding Calendar Year’s Selected Manufacturing Costs for such Zomig Nasal Spray. If the Selected Manufacturing Costs for any formulation or dosage of Zomig Nasal Spray increases by more than [***] on a per unit basis in any Calendar Year compared to the immediately preceding Calendar Year, then Impax shall have the right to terminate this Agreement as provided in Section 14.3.3. (iv) For clarity, (a) clauses (i) through (iii) also apply with respect to Impax Generic Versions of the applicable Existing ProductsSANCTURA XR designation, and (b) the calculation of any Royalty Tablet Offset Amount, Royalty ZMT Offset Amount and Royalty Nasal Offset Amount shall apply on a Calendar Year-by-Calendar Year basis additional costs incurred by Indevus that are not included in Indevus’ Manufacturing Costs but are associated with the amount production of Xxxxxx Marked Capsules, including manufacturing, testing and storing such Xxxxxx Marked Capsules, as well as any increase (testing or decrease) calculated solely on regulatory filings required by any Regulatory Authority. For example, if at any time during the basis of the immediately preceding Calendar Year. (v) This Section 8.15 shall be subject to Section 7.2.4 and 7.2.5. (vi) An example calculation with respect to clauses (i)Initial Supply Term, (ii) and (iii) Xxxxxx is set forth in Schedule 8.15.1(vi), which example is provided solely by way of example and without limitation. In the event of any conflict between the terms of Schedule 8.15.1(vi) and purchasing Xxxxxx Marked Capsules under this Agreement, this Agreement shall control. 8.15.2. AstraZeneca shall invoice Impax for Indevus’ Manufacturing Costs associated with the applicable production of Xxxxxx Marked Capsules are [*]and Indevus’ Manufacturing Costs that would have been associated with the production of the same quantity of Bulk Drug Product capsules marked with the SANCTURA XR designation are [*] then, in addition to the Supply Price together withfor such Xxxxxx Marked Capsules, or promptly after, each delivery to Impax of conforming supplies of the Supplied Products ordered by Impax. Impax Xxxxxx shall pay in full each such invoice in accordance with Section 7.4 within Indevus an additional [***] of the invoice dateXxxxxx Marked Capsules. 8.15.3. AstraZeneca has provided Impax with AstraZeneca’s Supply Prices for each Supplied 5.4.6 Sales of Bulk Drug Product for [***] for each Supplied Product for [***] between Xxxxxx and those Supply Prices shall remain in effect until [***]. AstraZeneca shall provide to Impax AstraZeneca’s Supply Prices for the following Calendar Years based upon [***] as provided in Section 8.15.1. Impax [***] may retain an Independent Auditor that is approved by AstraZeneca to conduct an audit of the basis for any Supply Price increase its Affiliates or decrease for a given Calendar Yearlicensees or sublicensees, which audit shall occur no more than [***] with respect to each Calendar Year or among such Affiliates and shall be conducted prior to [***] of the Calendar Year in which such increase licensees or decrease will be in effect. Any such approval with respect to the selection of an independent auditor sublicensees, shall not be unreasonably withheldconsidered sales of Bulk Drug Product for purposes of calculating the Manufacturing Payment, conditioned or delayed, and AstraZeneca shall respond to but in such request for approval pursuant to this Section 8.15.3 within [***]. AstraZeneca shall cooperate with such Independent Auditor’s investigation, and cases the results of any audit under this Section 8.15.3 shall (i) disclose only whether any increase or decrease in [***] under this Agreement is correct or incorrect and the amount of any discrepancy and (ii) be made available to both Parties. Prior to and as a condition to the Independent Auditor conducting any audit, Impax shall ensure that the Independent Auditor has entered into a confidentiality agreement with obligations no less restrictive than those obligations set forth in Article 11. In no event may the Independent Auditor disclose to Impax any documentation, calculations or information provided to the Independent Auditor by AstraZeneca that has not been approved by AstraZeneca, such approval not to be unreasonably withheld, conditioned or delayed, and AstraZeneca shall respond to such request for approval pursuant to this Section 8.15.3 within [***]. Except as provided below, the cost of this audit Manufacturing Payment shall be borne calculated on the number of capsules of Product sold by Impax, unless the audit reveals such Affiliates or licensees or sublicensees to Third Parties who are not a variance in the aggregate (taking account of all Supplied Products) of more than [***] from the reported Supply Price increase(s) Xxxxxx licensee or decrease(s) and the variance benefitted AstraZeneca, in which case AstraZeneca shall bear the cost of the audit. Unless disputed pursuant to Section 8.15.4, if such audit concludes for the period of time following the enactment of the applicable Supply Price increase or decrease that excess payments were made by Impax, AstraZeneca shall reimburse such excess payments with interest from the date originally due as provided in Section 7.6 within [***] after the date on which such audit is completed by Impaxsublicensee. 8.15.4. In the event of a dispute with respect to any audit under Section 8.15.3, AstraZeneca and Impax shall work in good faith to resolve the disagreement. If the Parties are unable to reach a mutually acceptable resolution of any such dispute within [***], the dispute shall be submitted for resolution to an Arbitrator. The decision of the Arbitrator shall be final and the costs of such arbitration as well as the initial audit shall be borne between the Parties in such manner as the Arbitrator shall determine. Not later than [***] after such decision and in accordance with such decision, the audited Party shall pay the additional amounts that were not paid, with interest from the date originally due as provided in Section 7.6, or the auditing Party shall reimburse the excess payments that were paid, as applicable.

Appears in 1 contract

Samples: License and Supply Agreement (Indevus Pharmaceuticals Inc)

Supply Price. 8.15.19.2.1 STPI shall pay DOR a certain SUPPLY PRICE, starting from the FIRST COMMERCIAL SALE of the PRODUCT and AG PRODUCT by STPI during the term of this AGREEMENT, as specified by the provisions of Appendix C attached hereto. 9.2.2 Upon the ninety (90) days prior to the date where DOR will be required to supply PRODUCT to STPI, DOR shall inform STPI of the amount of the FIXED COMPONENT of the SUPPLY PRICE. AstraZeneca DOR shall charge Impax on a per reasonably cooperate with any request by STPI to review DOR’s determination of the FIXED COMPONENT, but barring any clear error in calculation, the determination of DOR shall be conclusive. DOR shall inform STPI of any adjustment to the FIXED COMPONENT at least thirty (30) days prior to making such adjustment. DOR shall reasonably cooperate with any request by STPI to review DOR’s determination of the adjustment to FIXED COMPONENT, but barring any clear error in calculation, the determination of DOR shall be conclusive and STPI. 9.2.3 STPI shall keep accurate books and records setting forth the sales in unit basis a supply price and value, the selling prices, the NET SALES and the amount of SUPPLY PRICE payable to DOR hereunder, for each Supplied Product mode country of administration the TERRITORY with regard to the PRODUCT and dosage strength (the “Supply Price”)AG PRODUCT sold. DOR, which Supply Price initially at its discretion, shall be permitted either: to have performed by an independent certified public accounting firm of nationally recognized standing selected by DOR and reasonably acceptable to STPI, at DOR’s expense, yearly audits of STPI records and books related to the applicable PRODUCT and AG PRODUCT, provided such audits are reasonably conducted at STPI convenience and during STPI regular business hours. DOR’s representative or agent will be required to execute a reasonable and commercially customary confidentiality agreement with STPI prior to commencing any audit. Such auditor shall report to DOR only on the accuracy of the information provided by STPI (without taking any copies of STPI records and books) and whether additional amounts are owed. Such audits may be conducted for any calendar year ending not more than twenty-four (24) months prior to the date of each request. The right to audit with respect to any calendar year shall terminate three (3) years after the end of any such calendar year. In the event that a discrepancy arises between the SUPPLY PRICE paid to DOR and STPI records and books, STPI shall be given thirty (30) days from the receipt of the notice to either explain such discrepancy and/or remedy such discrepancy, as appropriate. Further, in the event of a discrepancy of more than five percent (5%) between the amount set forth owed and the actual amount received by DOR, STPI shall reimburse all the actual expenses and costs incurred by DOR in Schedule 8.15performing such audit. 1. [***]. During the Supply Term, AstraZeneca 9.2.4 The obligation to pay SUPPLY PRICE hereunder shall use reasonable efforts, consistent be imposed only once with the timing of its internal budget cycle, (i) respect to notify Impax on or before [***] of each Calendar Year for budget planning purposes of a preliminary Supply Price (including the Selected Manufacturing Costs contained in such Supply Price) for each Supplied Product mode of administration and dosage strength for the following Calendar Year, and (ii) to promptly notify Impax (in no event later than [***] of each Calendar Year) unit of the Supply Price PRODUCT and AG PRODUCT. No payments shall accrue on the sales of STPI to its AFFILIATED COMPANIES or sublicensees (including the Selected Manufacturing Costs contained if permitted) or distributors or agents as well as on any transactions between such entities. Payments shall accrue only on sales to unrelated third parties in such Supply Price) for each Supplied Product mode of administration and dosage strength for the following Calendar Year. Concurrently with the notice of each Supply Price increase or decrease (whether preliminary or final), AstraZeneca shall provide reasonable evidence to Impax of [***]in the Selected Manufacturing Costs for each Supplied Product mode of administration and dosage strengtharm’s length transactions. 9.2.5 Any taxes (iother than value added or income taxes) If STPI is required by the Selected Manufacturing Costs for any dosage strength local authorities to pay or withhold on behalf of Zomig Tablets increase on a per unit basis by more than [***] in any Calendar Year compared DOR with respect to the immediately preceding Calendar Year (money payable to DOR under this AGREEMENT shall be deducted from the amount of such excess Selected Manufacturing Cost increase above [***]payments, provided, however, that with regard to any such deduction STPI shall give DOR such assistance as may be necessary to enable or assist DOR to claim exception therefore (under US or other applicable laws as well as any applicable treaties or conventions) and shall give DOR proper evidence as to payment of the “Royalty Tablet Offset Amount”), then beginning on the date of such increase, the royalties payable by Impax pursuant to Section 7.2 on Zomig Tablets for each Calendar Quarter tax. Any other taxes due in the applicable Calendar Year shall be reduced by the Royalty Tablet Offset Amount attributable to those units TERRITORY and arising out of Zomig Tablets purchased by Impax at the applicable Supply Price during such Calendar Quarter; provided that the Royalty Tablet Offset Amount shall not exceed [***] on a per unit basis or in connection with STPI exercise of the immediately preceding Calendar Year’s Selected Manufacturing Costs for such Zomig Tablets. If the Selected Manufacturing Costs for any formulation or dosage of Zomig Tablets increases by more than [***] on a per unit basis in any Calendar Year compared to the immediately preceding Calendar Year, then Impax shall have the right to terminate this Agreement as provided in Section 14.3.3. (ii) If the Selected Manufacturing Costs for any dosage strength of Zomig-ZMT increase on a per unit basis by more than [***] in any Calendar Year compared to the immediately preceding Calendar Year (the amount of such excess Selected Manufacturing Cost increase above [***], the “Royalty ZMT Offset Amount”), then beginning on the date of such increase, the royalties payable by Impax pursuant to Section 7.2 on Zomig-ZMT for each Calendar Quarter in the applicable Calendar Year shall be reduced by the Royalty ZMT Offset Amount attributable to those units of Zomig-ZMT purchased by Impax at the applicable Supply Price during such Calendar Quarter; provided that the Royalty ZMT Offset Amount shall not exceed more than [***] on a per unit basis of the immediately preceding Calendar Year’s Selected Manufacturing Costs for such Zomig-ZMT. If the Selected Manufacturing Costs for any formulation or dosage of Zomig-ZMT increases by more than [***] on a per unit basis in any Calendar Year compared to the immediately preceding Calendar Year, then Impax shall have the right to terminate this Agreement as provided in Section 14.3.3. (iii) If the Selected Manufacturing Costs for any dosage strength of Zomig Nasal Spray increase on a per unit basis by more than [***] in any Calendar Year compared to the immediately preceding Calendar Year (the amount of such excess Selected Manufacturing Cost increase above [***], the “Royalty Nasal Offset Amount”), then beginning on the date of such increase, the royalties payable by Impax pursuant to Section 7.2 on Zomig Nasal Spray for each Calendar Quarter in the applicable Calendar Year shall be reduced by the Royalty Nasal Offset Amount attributable to those units of Zomig Nasal Spray purchased by Impax at the applicable Supply Price during such Calendar Quarter; provided that the Royalty Nasal Offset Amount shall not exceed more than [***] on a per unit basis of the immediately preceding Calendar Year’s Selected Manufacturing Costs for such Zomig Nasal Spray. If the Selected Manufacturing Costs for any formulation or dosage of Zomig Nasal Spray increases by more than [***] on a per unit basis in any Calendar Year compared to the immediately preceding Calendar Year, then Impax shall have the right to terminate this Agreement as provided in Section 14.3.3. (iv) For clarity, (a) clauses (i) through (iii) also apply with respect to Impax Generic Versions of the applicable Existing Products, and (b) the calculation of any Royalty Tablet Offset Amount, Royalty ZMT Offset Amount and Royalty Nasal Offset Amount shall apply on a Calendar Year-by-Calendar Year basis with the amount of any increase (or decrease) calculated solely on the basis of the immediately preceding Calendar Year. (v) This Section 8.15 shall be subject to Section 7.2.4 and 7.2.5. (vi) An example calculation with respect to clauses (i), (ii) and (iii) is set forth in Schedule 8.15.1(vi), which example is provided solely by way of example and without limitation. In the event of any conflict between the terms of Schedule 8.15.1(vi) and this Agreement, this Agreement shall control. 8.15.2. AstraZeneca shall invoice Impax for the applicable Supply Price together with, or promptly after, each delivery to Impax of conforming supplies of the Supplied Products ordered by Impax. Impax shall pay in full each such invoice in accordance with Section 7.4 within [***] of the invoice date. 8.15.3. AstraZeneca has provided Impax with AstraZeneca’s Supply Prices for each Supplied Product for [***] for each Supplied Product for [***] and those Supply Prices shall remain in effect until [***]. AstraZeneca shall provide to Impax AstraZeneca’s Supply Prices for the following Calendar Years based upon [***] as provided in Section 8.15.1. Impax [***] may retain an Independent Auditor that is approved by AstraZeneca to conduct an audit of the basis for any Supply Price increase or decrease for a given Calendar Year, which audit shall occur no more than [***] with respect to each Calendar Year and shall be conducted prior to [***] of the Calendar Year in which such increase or decrease will be in effect. Any such approval with respect to the selection of an independent auditor shall not be unreasonably withheld, conditioned or delayed, and AstraZeneca shall respond to such request for approval pursuant to this Section 8.15.3 within [***]. AstraZeneca shall cooperate with such Independent Auditor’s investigation, and the results of any audit under this Section 8.15.3 shall (i) disclose only whether any increase or decrease in [***] under this Agreement is correct or incorrect and the amount of any discrepancy and (ii) be made available to both Parties. Prior to and as a condition to the Independent Auditor conducting any audit, Impax shall ensure that the Independent Auditor has entered into a confidentiality agreement with obligations no less restrictive than those obligations set forth in Article 11. In no event may the Independent Auditor disclose to Impax any documentation, calculations or information provided to the Independent Auditor by AstraZeneca that has not been approved by AstraZeneca, such approval not to be unreasonably withheld, conditioned or delayed, and AstraZeneca shall respond to such request for approval pursuant to this Section 8.15.3 within [***]. Except as provided below, the cost of this audit rights granted herein shall be borne by Impax, unless the audit reveals a variance in the aggregate (taking account of all Supplied Products) of more than [***] from the reported Supply Price increase(s) or decrease(s) and the variance benefitted AstraZeneca, in which case AstraZeneca STPI. STPI shall bear the cost of the audit. Unless disputed pursuant to Section 8.15.4, if such audit concludes not be responsible for the period of time following the enactment of the applicable Supply Price increase or decrease that excess payments were made by Impax, AstraZeneca shall reimburse such excess payments with interest from the date originally due as provided in Section 7.6 within [***] after the date on which such audit is completed by Impaxpaying DOR’s income tax. 8.15.4. In the event of a dispute with respect to any audit under Section 8.15.3, AstraZeneca and Impax shall work in good faith to resolve the disagreement. If the Parties are unable to reach a mutually acceptable resolution of any such dispute within [***], the dispute shall be submitted for resolution to an Arbitrator. The decision of the Arbitrator shall be final and the costs of such arbitration as well as the initial audit shall be borne between the Parties in such manner as the Arbitrator shall determine. Not later than [***] after such decision and in accordance with such decision, the audited Party shall pay the additional amounts that were not paid, with interest from the date originally due as provided in Section 7.6, or the auditing Party shall reimburse the excess payments that were paid, as applicable.

Appears in 1 contract

Samples: Collaboration and Supply Agreement (Dor Biopharma Inc)

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Supply Price. 8.15.1. AstraZeneca shall charge Impax on a per unit basis a supply price for each Supplied Product mode of administration and dosage strength (the “Supply Price”), which The Supply Price initially for the MUSE Product shall be the applicable amount set forth in Schedule 8.15. 1. [equal (***]) of Abboxx'x Xxx Sales of the MUSE Product in the Territory, calculated as provided in Article 4.2(B) below. During The Supply Price for the Supply Term, AstraZeneca ALIBRA Product shall use reasonable efforts, consistent with the timing of its internal budget cycle, equal (i) to notify Impax on or before [***] of each Calendar Year for budget planning purposes of a preliminary Supply Price (including the Selected Manufacturing Costs contained in such Supply Price) for each Supplied Product mode of administration and dosage strength for the following Calendar Year, and (ii) to promptly notify Impax (in no event later than [***] of each Calendar Year) of Abboxx'x Xxx Sales of the Supply Price (including the Selected Manufacturing Costs contained in such Supply Price) for each Supplied ALIBRA Product mode of administration and dosage strength for the following Calendar Year. Concurrently with the notice of each Supply Price increase or decrease (whether preliminary or final), AstraZeneca shall provide reasonable evidence to Impax of [***]in the Selected Manufacturing Costs for each Supplied Product mode of administration and dosage strength. (i) If the Selected Manufacturing Costs for any dosage strength of Zomig Tablets increase on a per unit basis by more than [***] in any Calendar Year compared to the immediately preceding Calendar Year (the amount of such excess Selected Manufacturing Cost increase above [***]Territory, the “Royalty Tablet Offset Amount”), then beginning on the date of such increase, the royalties payable by Impax pursuant to Section 7.2 on Zomig Tablets for each Calendar Quarter in the applicable Calendar Year shall be reduced by the Royalty Tablet Offset Amount attributable to those units of Zomig Tablets purchased by Impax at the applicable Supply Price during such Calendar Quarter; provided that the Royalty Tablet Offset Amount shall not exceed [***] on a per unit basis of the immediately preceding Calendar Year’s Selected Manufacturing Costs for such Zomig Tablets. If the Selected Manufacturing Costs for any formulation or dosage of Zomig Tablets increases by more than [***] on a per unit basis in any Calendar Year compared to the immediately preceding Calendar Year, then Impax shall have the right to terminate this Agreement calculated as provided in Section 14.3.3. (iiArticle 4.2(B) If the Selected Manufacturing Costs for any dosage strength of Zomig-ZMT increase on a per unit basis by more than [***] in any Calendar Year compared to the immediately preceding Calendar Year (the amount of such excess Selected Manufacturing Cost increase above [***], the “Royalty ZMT Offset Amount”), then beginning on the date of such increase, the royalties payable by Impax pursuant to Section 7.2 on Zomig-ZMT for each Calendar Quarter in the applicable Calendar Year shall be reduced by the Royalty ZMT Offset Amount attributable to those units of Zomig-ZMT purchased by Impax at the applicable below. The Supply Price during such Calendar Quarter; provided that the Royalty ZMT Offset Amount shall not exceed more than [***] on a per unit basis of the immediately preceding Calendar Year’s Selected Manufacturing Costs for such Zomig-ZMT. If the Selected Manufacturing Costs for any formulation or dosage of Zomig-ZMT increases by more than [***] on a per unit basis in any Calendar Year compared to the immediately preceding Calendar Year, then Impax shall have the right to terminate this Agreement as provided in Section 14.3.3. (iii) If the Selected Manufacturing Costs for any dosage strength of Zomig Nasal Spray increase on a per unit basis by more than [***] in any Calendar Year compared to the immediately preceding Calendar Year (the amount of such excess Selected Manufacturing Cost increase above [***], the “Royalty Nasal Offset Amount”), then beginning on the date of such increase, the royalties payable by Impax pursuant to Section 7.2 on Zomig Nasal Spray for each Calendar Quarter in the applicable Calendar Year shall be reduced by the Royalty Nasal Offset Amount attributable to those units of Zomig Nasal Spray purchased by Impax at the applicable Supply Price during such Calendar Quarter; provided that the Royalty Nasal Offset Amount shall not exceed more than [***] on a per unit basis of the immediately preceding Calendar Year’s Selected Manufacturing Costs for such Zomig Nasal Spray. If the Selected Manufacturing Costs for any formulation or dosage of Zomig Nasal Spray increases by more than [***] on a per unit basis in any Calendar Year compared to the immediately preceding Calendar Year, then Impax shall have the right to terminate this Agreement as provided in Section 14.3.3. (iv) For clarity, (a) clauses (i) through (iii) also apply with respect to Impax Generic Versions of the applicable Existing Products, and (b) the calculation of any Royalty Tablet Offset Amount, Royalty ZMT Offset Amount and Royalty Nasal Offset Amount shall apply on a Calendar Year-by-Calendar Year basis with the amount of any increase (or decrease) calculated solely on the basis of the immediately preceding Calendar Year. (v) This Section 8.15 both Products shall be subject to Section 7.2.4 and 7.2.5the provisions of Article 4.3 below. (viA) An example calculation In order to enable the parties to sell and purchase the Products prior to the time in which Abboxx'x Xxx Sales for a Sales Quarter are determined, Abbott shall pay for Products ordered, delivered and accepted pursuant to Article 5 below based upon an interim "Transfer Price," which shall be equal to (***) of Abboxx'x xxximated weighted average net selling price for an Abbott fiscal year, for the Products in the Territory, respectively for the MUSE Product and for the ALIBRA Product. Abbott shall advise VIVUS no later than forty-five (45) days prior to the start of each of Abboxx'x xxxcal years, during the term of this Agreement, of Abboxx'x xxximated weighted average net selling price for each of the Products in the Territory for the coming Abbott fiscal year, and the Transfer Price for that fiscal year shall be based upon such price, subject to any adjustment required under Article 4.2(B) below. (B) The parties shall conduct a reconciliation no later than forty-five (45) days after the end of each Sales Quarter, in order to determine whether one party owes the other party any amount in connection with respect the sale and purchase of the MUSE Product and/or the ALIBRA Product in that Sales Quarter, based upon the difference (if any) between the respective Transfer Price and the Supply Price for that Sales Quarter. For the purposes of such reconciliation, Abbott shall provide to clauses (i)VIVUS a statement of Abboxx'x xxxes in units, (ii) per country in the Territory, and (iii) is set forth of Abboxx'x Xxx Sales, per country in Schedule 8.15.1(vi)the Territory and in local currency as well as in U.S. dollars, which example is provided solely by way of example and without limitationconverted pursuant to Article 4.7 below. In the event of that one party owes the other party any conflict between the terms of Schedule 8.15.1(vi) and this Agreement, this Agreement shall control. 8.15.2. AstraZeneca shall invoice Impax for the applicable Supply Price together with, or promptly after, each delivery to Impax of conforming supplies of the Supplied Products ordered by Impax. Impax shall pay in full each such invoice amount in accordance with Section 7.4 this Article 4.2(B), the owing party shall pay such amount within [***] thirty (30) days of the invoice date. 8.15.3. AstraZeneca has provided Impax with AstraZeneca’s Supply Prices for each Supplied Product for [***] for each Supplied Product for [***] and those Supply Prices shall remain date upon which the parties have agreed in effect until [***]. AstraZeneca shall provide to Impax AstraZeneca’s Supply Prices for writing upon the following Calendar Years based upon [***] as provided in Section 8.15.1. Impax [***] may retain an Independent Auditor that is approved by AstraZeneca to conduct an audit of the basis for any Supply Price increase or decrease for a given Calendar Year, which audit shall occur no more than [***] with respect to each Calendar Year and shall be conducted prior to [***] of the Calendar Year in which such increase or decrease will be in effect. Any such approval with respect to the selection of an independent auditor shall not be unreasonably withheld, conditioned or delayed, and AstraZeneca shall respond to such request for approval pursuant to this Section 8.15.3 within [***]. AstraZeneca shall cooperate with such Independent Auditor’s investigation, and the results of any audit under this Section 8.15.3 shall (i) disclose only whether any increase or decrease in [***] under this Agreement is correct or incorrect and the amount of any discrepancy and (ii) be made available to both Parties. Prior to and as a condition to the Independent Auditor conducting any audit, Impax shall ensure that the Independent Auditor has entered into a confidentiality agreement with obligations no less restrictive than those obligations set forth in Article 11. In no event may the Independent Auditor disclose to Impax any documentation, calculations or information provided to the Independent Auditor by AstraZeneca that has not been approved by AstraZeneca, such approval not to be unreasonably withheld, conditioned or delayed, and AstraZeneca shall respond to such request for approval pursuant to this Section 8.15.3 within [***]. Except as provided below, the cost of this audit shall be borne by Impax, unless the audit reveals a variance in the aggregate (taking account of all Supplied Products) of more than [***] from the reported Supply Price increase(s) or decrease(s) and the variance benefitted AstraZeneca, in which case AstraZeneca shall bear the cost of the audit. Unless disputed pursuant to Section 8.15.4, if such audit concludes for the period of time following the enactment of the applicable Supply Price increase or decrease that excess payments were made by Impax, AstraZeneca shall reimburse such excess payments with interest from the date originally due as provided in Section 7.6 within [***] after the date on which such audit is completed by Impax. 8.15.4reconciliation calculation. In the event that the Supply Price is greater than one hundred ten percent (110%) or less than ninety percent (90%) of a dispute with respect to any audit under Section 8.15.3, AstraZeneca and Impax shall work in good faith to resolve the disagreement. If the Parties are unable to reach a mutually acceptable resolution of any such dispute within [***]Transfer Price for two (2) consecutive Sales Quarters, the dispute Transfer Price established in Article 4.2(A) above shall be submitted changed for resolution the remainder of that Sales Year to an Arbitrator. The decision of the Arbitrator shall be final and Supply Price applicable to the costs of such arbitration as well as the initial audit shall be borne between the Parties in such manner as the Arbitrator shall determine. Not later than [***] after such decision and in accordance with such decision, the audited Party shall pay the additional amounts that were not paid, with interest from the date originally due as provided in Section 7.6, or the auditing Party shall reimburse the excess payments that were paid, as applicablemost recent Sales Quarter.

Appears in 1 contract

Samples: License and Supply Agreement (Vivus Inc)