Failure to Supply. (a) In the event that it becomes apparent to uniQure that it will be unable to fulfill any Confirmed Firm Order for the Product (“Failure to Supply”), uniQure shall, immediately after learning of such event or circumstances, notify Chiesi in writing of uniQure’s Failure to Supply, along with a reasonable explanation of the reason, to the extent then known to uniQure, for uniQure’s Failure to Supply and with a specific indication of the quantity of Product affected by such Failure to Supply and anticipated timing of delivery of the Product. Promptly after Chiesi’s receipt of any such notice, the Parties shall agree upon mutually acceptable revised quantities and delivery dates with respect to the Product subject to such Confirmed Firm Order or, to the extent this is not possible in light of the specific or then unknown reason for uniQure’s Failure to Supply, shall discuss in good faith measures to further investigate the root cause and, as the case may be, appropriate steps to overcome such Failure to Supply. (b) Notwithstanding paragraph (a), in the event that Chiesi cannot fulfill any firm orders for the Product received from any Third Parties as a consequence of uniQure’s Failure to Supply, except if such Failure to Supply is caused as a result of any Force Majeure Event, then Chiesi shall be entitled to an indemnification payment equal to Chiesi’s Lost Profit for the period during which Chiesi has been affected by the Failure to Supply. Any indemnification payment made to Chiesi under this paragraph for Failure to Supply shall be reimbursed in full to uniQure, in case any patient who suffered from the Failure to Supply is then subsequently treated. Such indemnification payments and reimbursements, if any, shall be calculated on a calendar year basis, such calculation to be made within [**] days after the end of the corresponding calendar year and any resulting amount to be paid within [**] days after such calculation has been made. uniQure, in relying on the above Force Majeure Event exceptions, shall provide reasonably detailed particulars of the reasons underlying any such Force Majeure Event to Chiesi and shall allocate its existing stocks of the Product between uniQure, its Affiliates, Chiesi and other distributors of the Product, on a pro-rata basis, based upon order volumes for the Product for the prior [**]month period. (c) For the purpose of this Section 2.6, “Profit” shall be calculated, on a per Product basis, as the difference between (a) the relevant Average Net Sales Price that would have applied to the Product affected by the Failure to Supply and (b) the applicable Purchase Price for the Product affected by the Failure to Supply calculated as per Section 2.3 above, and “Lost Profit” shall mean the accumulated Profit for all quantities of Product affected by the Failure to Supply.
Appears in 2 contracts
Sources: Commercialization Agreement (uniQure B.V.), Commercialization Agreement (uniQure B.V.)
Failure to Supply. (a) In the event that it becomes apparent to uniQure that it will be unable to fulfill any Confirmed Firm Order for the Product (“Failure to Supply”), uniQure shall, immediately after learning of such event or circumstances, notify Chiesi in writing of uniQure’s Failure to Supply, along with a reasonable explanation of the reason, to the extent then known to uniQure, for uniQure’s Failure to Supply and with a specific indication of the quantity of Product affected by such Failure to Supply and anticipated timing of delivery of the Product. Promptly after Chiesi’s receipt of any such notice, the Parties shall agree upon mutually acceptable revised quantities and delivery dates with respect to the Product subject to such Confirmed Firm Order or, to the extent this is not possible in light of the specific or then unknown reason for uniQure’s Failure to Supply, shall discuss in good faith measures to further investigate the root cause and, as the case may be, appropriate steps to overcome such Failure to Supply.
(b) Notwithstanding paragraph (a), in the event that Chiesi cannot fulfill any firm orders for the Product received from any Third Parties as a consequence of uniQure’s Failure to Supply, except if such Failure to Supply is caused as a result of any Force Majeure Event, then Chiesi shall be entitled to an indemnification payment equal to Chiesi’s Lost Profit for the period during which Chiesi has been affected by the Failure to Supplyto[†]. Any indemnification payment made to Chiesi under this paragraph for Failure to Supply shall be reimbursed in full to uniQure, in case any patient who suffered from the Failure to Supply is then subsequently treateduniQure,[†]. Such indemnification payments and reimbursements, if any, shall be calculated on a calendar year basis, such calculation to be made within [**†] days after the end of the corresponding calendar year and any resulting amount to be paid within [**†] days after such calculation has been made. uniQure, in relying on the above Force Majeure Event exceptions, shall provide reasonably detailed particulars of the reasons underlying any such Force Majeure Event to Chiesi and shall allocate its existing stocks of the Product between uniQure, its Affiliates, Chiesi and other distributors of the Product, on a pro-rata basis, based upon order volumes for the Product for the prior [**shall[†]month period.
(c) For the purpose of this Section 2.6, “Profit” shall be calculated, on a per Product basis, as the difference between (a) the relevant Average Net Sales Price that would have applied to the Product affected by the Failure to Supply [†] and (b) the applicable Purchase Price for the Product affected by the Failure to Supply [†] calculated as per Section 2.3 above[†], and “Lost Profit” shall mean the accumulated Profit for all quantities of Product affected by the Failure to Supplythe[†].
Appears in 1 contract
Sources: Sublicense and Research Agreement (Xenon Pharmaceuticals Inc.)
Failure to Supply. (a) In Notwithstanding the provisions of Section 11.01, in the event that it becomes apparent to uniQure that it will Supplier shall be unable or unwilling or shall fail to fulfill supply any Confirmed Firm Order for Product in such quantities as Buyer shall request and in compliance with the Product delivery periods set forth in Section 4.02 (whether due to the occurrence of a Force Majeure Event, following the commencement of a case by or against Supplier under the Bankruptcy Code or otherwise (hereinafter referred to as a “Failure to Supply”), uniQure shall, immediately then Buyer shall be permitted (after learning the expiration of such event or circumstances, notify Chiesi in writing a ***** day cure period following written notice from Buyer to supplier of uniQure’s Failure to Supply, along with a reasonable explanation of the reason, to the extent then known to uniQure, for uniQure’s Failure to Supply and with a specific indication of the quantity of Product affected by such Failure to Supply and anticipated timing such Failure to Supply has not been cured by Supplier) to (i) obtain Product directly from Cardinal, (ii) to obtain such Product from another supplier, or (iii) to use, sell, and make Product itself either in the Cardinal Facility or at another location. In this regard, Supplier shall (at no cost to Supplier) take all actions and provide all such cooperation and support reasonably necessary and reasonably within its control to give Buyer the right to enter, upon reasonable notice and during regular business hours, and shall be given access to, the Cardinal Facility (or any other location where the Equipment is used or stored) so that Buyer may use or retrieve all records maintained in connection with the manufacturing equipment. Supplier’s obligations under this Section shall survive the termination of delivery this Agreement for a period of ***** months. Upon the Product. Promptly after Chiesi’s receipt occurrence of any such noticeFailure to Supply and through and until such time as Supplier fully resumes its supply obligations hereunder: (a) Supplier shall (at no cost to Supplier) take all reasonable actions within its control, execute and deliver all documents, and provide all such assistance as Buyer reasonably requests to enable Buyer to obtain Product directly from Cardinal; (b) Supplier shall (at no cost to Supplier) make available to Buyer or its designee access to any and all Intellectual * Confidential information has been omitted and filed separately with the Parties shall agree upon mutually acceptable revised quantities Securities and delivery dates with respect Exchange Commission pursuant to the Product subject to such Confirmed Firm Order or, a confidential treatment request. Property Rights (to the extent not already granted pursuant to the License Agreement) and any other technical and proprietary materials, information and techniques necessary or helpful for Buyer to procure required Raw Materials or produce or arrange an alternative supplier of Product; (c) Supplier shall (at no cost to Supplier) provide advice and consultation in connection therewith; (d) Buyer shall purchase Product from Supplier once Supplier has cured the failure to supply; and (e) Buyer shall terminate any contractual arrangements contemplated by clause (a) of this is not possible in light of sentence once Supplier has cured the specific or then unknown reason for uniQure’s failure to supply. As soon as reasonably practicable after an uncured Failure to Supply, Supplier shall discuss in good faith measures to further investigate the root cause and, furnish Buyer with Licensed Know-How (as the case may be, appropriate steps to overcome such Failure to Supply.
(b) Notwithstanding paragraph (a), defined in the event that Chiesi cannot fulfill any firm orders for the License Agreement) which is necessary to enable Buyer to manufacture or have manufactured Product received from any Third Parties as a consequence of uniQure’s Failure to Supply, except if such Failure to Supply is caused as a result of any Force Majeure Event, then Chiesi shall be entitled to an indemnification payment equal to Chiesi’s Lost Profit for the period during which Chiesi has been affected contemplated by the Failure to Supply. Any indemnification payment made to Chiesi under this paragraph for Failure to Supply shall be reimbursed in full to uniQure, in case any patient who suffered from the Failure to Supply is then subsequently treated. Such indemnification payments and reimbursements, if any, shall be calculated on a calendar year basis, such calculation to be made within [**] days after the end of the corresponding calendar year and any resulting amount to be paid within [**] days after such calculation has been made. uniQure, in relying on the above Force Majeure Event exceptions, shall provide reasonably detailed particulars of the reasons underlying any such Force Majeure Event to Chiesi and shall allocate its existing stocks of the Product between uniQure, its Affiliates, Chiesi and other distributors of the Product, on a pro-rata basis, based upon order volumes for the Product for the prior [**]month periodAgreement.
(c) For the purpose of this Section 2.6, “Profit” shall be calculated, on a per Product basis, as the difference between (a) the relevant Average Net Sales Price that would have applied to the Product affected by the Failure to Supply and (b) the applicable Purchase Price for the Product affected by the Failure to Supply calculated as per Section 2.3 above, and “Lost Profit” shall mean the accumulated Profit for all quantities of Product affected by the Failure to Supply.
Appears in 1 contract
Sources: Supply Agreement (Novavax Inc)
Failure to Supply. Notwithstanding the provisions of Section 11.1 (a) In Force Majeure Events), in the event that it becomes apparent to uniQure that it will Supplier shall be unable or unwilling or April 21, 2006 Novavax Esprit Supply Agreement shall fail to fulfill supply any Confirmed Firm Order for Product in such quantities as Buyer shall request and in compliance with the Product delivery periods set forth in Section 4.3 (Change Orders) (whether due to the occurrence of a Force Majeure Event, following the commencement of a case by or against Supplier under the Bankruptcy Code or otherwise (hereinafter referred to as a “Failure to Supply”), uniQure shall, immediately then Buyer shall be permitted (after learning the expiration of such event or circumstances, notify Chiesi in writing a *** cure period following written notice from Buyer to supplier of uniQure’s Failure to Supply, along with a reasonable explanation of the reason, to the extent then known to uniQure, for uniQure’s Failure to Supply and with a specific indication of the quantity of Product affected by such Failure to Supply and anticipated timing such Failure to Supply has not been cured by Supplier) to (i) to obtain such Product from another supplier including Cardinal, or (ii) to use, sell, and make Product itself in the Cardinal Red Lion facility or at another location. In this regard, Supplier shall (at no cost to Supplier) take all actions and provide all such cooperation and support reasonably necessary and reasonably within its control to give Buyer the right to enter, upon reasonable notice and during regular business hours, and shall be given access to, the Facility (or any other location where the Equipment is used or stored) so that Buyer may use or retrieve all records maintained in connection with the manufacturing equipment. Supplier’s obligations under this Section shall survive the termination of delivery this Agreement for a period of ***. Upon the Product. Promptly after Chiesi’s receipt occurrence of any such noticeFailure to Supply and through and until such time as Supplier fully resumes its supply obligations hereunder: (a) Supplier shall (at no cost to Supplier) take all reasonable actions within its control, the Parties execute and deliver all documents, and provide all such assistance as Buyer reasonably requests to enable Buyer to obtain Product from another supplier or to manufacture April 21, 2006 Novavax Esprit Supply Agreement Product itself; (b) Supplier shall agree upon mutually acceptable revised quantities (at no cost to Supplier) make available to Buyer or its designee access to any and delivery dates with respect to the Product subject to such Confirmed Firm Order or, all Intellectual Property Rights (to the extent not already granted pursuant to the License Agreement) and any other technical and proprietary materials, information and techniques necessary or helpful for Buyer to procure required Raw Materials or produce or arrange an alternative supplier of Product; (c) Supplier shall (at no cost to Supplier) provide advice and consultation in connection therewith; (d) Buyer shall purchase Product from Supplier once Supplier has cured the failure to supply; and (e) Buyer shall terminate any contractual arrangements contemplated by clause (a) of this is not possible in light of sentence once Supplier has cured the specific or then unknown reason for uniQure’s failure to supply. As soon as reasonably practicable after an uncured Failure to Supply, Supplier shall discuss furnish Buyer with Licensed Know-How (as defined in the License Agreement) which is necessary to enable Buyer to manufacture or have manufactured Product as contemplated by this Agreement. In the event either party hereto believes it to be in the best interest of both parties, as the licensor and licensee of the Licensed Product in the Territory, to designate and qualify an alternate contract manufacturer of the Licensed Product, each party shall consider in good faith measures the views of the other party as to further investigate the root cause and, as the case may be, appropriate steps to overcome such Failure to Supply.
(b) Notwithstanding paragraph (a), in the event that Chiesi cannot fulfill any firm orders for the Product received from any Third Parties as a consequence advisability of uniQure’s Failure to Supply, except if such Failure to Supply is caused as a result of any Force Majeure Event, then Chiesi shall be entitled to engaging an indemnification payment equal to Chiesi’s Lost Profit for the period during which Chiesi has been affected alternate contract manufacturer. If agreed by the Failure parties that an alternate contract manufacturer should be designated and qualified, the parties shall cooperate to Supply. Any indemnification payment made to Chiesi under this paragraph for Failure to Supply shall be reimbursed in full to uniQure, in case any patient who suffered from ensure the Failure to Supply is then subsequently treated. Such indemnification payments and reimbursements, if any, shall be calculated on a calendar year basis, such calculation to be made within [**] days after the end transition of the corresponding calendar year and Licensed Product manufacturing to a third party in a manner that minimizes any resulting amount to be paid interruption of supply of Licensed Product within [**] days after such calculation has been madethe Territory. uniQureApril 21, in relying on the above Force Majeure Event exceptions, shall provide reasonably detailed particulars of the reasons underlying any such Force Majeure Event to Chiesi and shall allocate its existing stocks of the Product between uniQure, its Affiliates, Chiesi and other distributors of the Product, on a pro-rata basis, based upon order volumes for the Product for the prior [**]month period.
(c) For the purpose of this Section 2.6, “Profit” shall be calculated, on a per Product basis, as the difference between (a) the relevant Average Net Sales Price that would have applied to the Product affected by the Failure to 2006 Novavax Esprit Supply and (b) the applicable Purchase Price for the Product affected by the Failure to Supply calculated as per Section 2.3 above, and “Lost Profit” shall mean the accumulated Profit for all quantities of Product affected by the Failure to Supply.Agreement
Appears in 1 contract
Sources: Supply Agreement (Novavax Inc)
Failure to Supply. 4.1 In the event MD ▇▇▇▇▇▇▇▇ is not able to supply, or reasonably anticipates that it will not be able to supply, any Services under any Work Order for any reason, including without limitation force majeure according to Section 11.8, MD ▇▇▇▇▇▇▇▇ shall (ai) without undue delay provide a written notice (e-mail is sufficient) to Bellicum stating in reasonable detail the cause of such supply inability and the proposed remedial measures and the date such inability is expected to end, and (ii) use commercially reasonable efforts to supply such Services as soon as practicable. The Parties will discuss in good faith all appropriate means of resolving such supply problems.
4.2 In the event that it becomes apparent to uniQure that it will be MD ▇▇▇▇▇▇▇▇ is unable to fulfill Manufacture and release three (3) consecutive Patient Lots of the same Deliverable or a total of six (6) Patient Lots of the same Deliverable in any Confirmed Firm rolling twelve (12) month period as required under a Work Order for the Product (“Failure to Supply”excluding, in both circumstances, any Deliverables impacted by Process Inherent Issues), uniQure shall, immediately after learning of such event or circumstances, notify Chiesi in writing of uniQure’s Failure to Supply, along with a reasonable explanation of the reason, to the extent then known to uniQure, for uniQure’s Failure to Supply and with a specific indication of the quantity of Product affected by such Failure to Supply and anticipated timing of provided all Bellicum Obligations have been successfully met including timely delivery of the ProductMaterials to MD ▇▇▇▇▇▇▇▇, then a supply interruption shall be deemed to have occurred (“Supply Interruption”). Promptly after Chiesi’s receipt of any Provided that such noticeSupply Interruption is not (a) caused by force majeure according to Section 11.8, the Parties shall agree upon mutually acceptable revised quantities and delivery dates with respect (b) due to the Product subject fault of Bellicum or any Third Party, or (c) due to such Confirmed Firm Order orany Process Inherent Issue, a supply failure shall be deemed to have occurred (“Supply Failure”). In the extent this is not possible in light event of a Supply Failure, MD ▇▇▇▇▇▇▇▇ shall, within sixty (60) calendar days from the beginning of the specific or then unknown reason for uniQure’s Failure Supply Failure, prepare an action plan setting forth a proposal to Supply, shall discuss in good faith measures to further investigate determine the root cause andof the Supply Failure and the corrective actions to be taken (the “Action Plan”). The Action Plan shall then be presented to the JSC within such sixty (60) day period. The JSC may accept, modify or reject such Action Plan. In the event the JSC cannot agree upon the proposed (or modified) Action Plan within fourteen (14) days, the matter shall be escalated to the senior management of the Parties in accordance with Section 10.2. If senior management, acting in good faith, cannot agree on an Action Plan within forty-five (45) days from the date of its referral to senior management, then MD ▇▇▇▇▇▇▇▇ shall have the right to terminate this Agreement upon fifteen (15) days notice.
4.3 Upon determination that a Supply Failure has occurred and is incapable of being cured within sixty (60) days from the date it is deemed a Supply Failure, the Term of such applicable Work Order, as the case may be, appropriate steps it related to overcome such Failure to Supply.
(b) Notwithstanding paragraph (a), in the event that Chiesi cannot fulfill any firm orders for the Product received from any Third Parties as a consequence of uniQure’s Failure to Supply, except if such Failure to Supply is caused as a result of any Force Majeure Event, then Chiesi shall be entitled to an indemnification payment equal to Chiesi’s Lost Profit for the period during which Chiesi has been affected by the Failure to Supply. Any indemnification payment made to Chiesi under this paragraph for Failure to Supply shall be reimbursed in full to uniQure, in case any patient who suffered from the Failure to Supply is then subsequently treated. Such indemnification payments and reimbursements, if anyspecific Deliverable, shall be calculated on a calendar year basisautomatically extended for the length of such Supply Failure (unless otherwise terminated in accordance with Section 4.2). For the avoidance of doubt, such calculation to be made within [**] days after the end length of the corresponding calendar year Supply Failure arising from the failure to Manufacture and any resulting amount to be paid within [**] days after such calculation has been made. uniQurerelease three (3) consecutive Patient Lots of the same Deliverable, in relying shall commence on the above Force Majeure Event exceptionsdate of the first failed Patient Lot and conclude on the successful implementation of the Action Plan, and the length of the Supply Failure arising from the failure to Manufacture and release a total of six (6) Patient Lots of the same Deliverable in any rolling twelve (12) month period, shall provide reasonably detailed particulars commence on the date of the reasons underlying any such Force Majeure Event to Chiesi last failed Patient Lot and shall allocate its existing stocks conclude on the successful implementation of the Product between uniQure, its Affiliates, Chiesi and other distributors of the Product, on a pro-rata basis, based upon order volumes for the Product for the prior [**]month periodAction Plan.
(c) For the purpose of this Section 2.6, “Profit” shall be calculated, on a per Product basis, as the difference between (a) the relevant Average Net Sales Price that would have applied to the Product affected by the Failure to Supply and (b) the applicable Purchase Price for the Product affected by the Failure to Supply calculated as per Section 2.3 above, and “Lost Profit” shall mean the accumulated Profit for all quantities of Product affected by the Failure to Supply.
Appears in 1 contract
Sources: Asset Purchase Agreement (Bellicum Pharmaceuticals, Inc)
Failure to Supply. (a) In the event that it becomes apparent to uniQure that it will be unable to fulfill at any Confirmed Firm Order for time during the Product term of the Agreement, Licensor delivers non-conforming lots of the Initial Product, as further defined in the Technical Agreement, three (3) times in any twelve (12) month period (a “Failure to SupplyDefault”), uniQure shall, immediately after learning then:
(a) Licensee shall give written notice to Licensor specifying the occurrence of such event or circumstances, notify Chiesi in writing of uniQure’s Failure to Supply, along with a reasonable explanation of the reasonDefault (and, to the extent then Licensor anticipates a possible Default, Licensor shall inform Licensee of such possibility as it becomes known to uniQure, for uniQure’s Failure to Supply and with a specific indication Licensor);
(b) The JSC shall investigate the cause of the quantity of Product affected by such Failure to Supply and anticipated timing of delivery of the ProductDefault. Promptly after Chiesi’s receipt of any such noticeThereafter, the Parties shall agree upon mutually acceptable revised quantities and delivery dates with respect to the Product subject to such Confirmed Firm Order or, to the extent this is not possible in light of the specific or then unknown reason for uniQure’s Failure to Supply, shall discuss in good faith measures through the JSC the appropriate mechanism to further investigate cure the root cause andDefault based on the JSC’s investigation. Such mechanisms for cure may include for example, as but without limitation, the case may beestablishment by Licensor of a secondary source for the manufacture and supply of Initial [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, appropriate steps 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. Product to overcome Licensee. In addition, where there is limited supply of conforming Licensed Product, the JSC shall determine the allocation of the available Licensed Product between the Licensor Territory and the Territory, taking into consideration the sales volume of such Failure to Supply.
(b) Notwithstanding paragraph (a), territories in the event that Chiesi cannot fulfill any firm orders for the Product received from any Third Parties as a consequence of uniQure’s Failure to Supply, except if such Failure to Supply is caused as a result of any Force Majeure Event, then Chiesi shall be entitled to an indemnification payment equal to Chiesi’s Lost Profit for the period during which Chiesi has been affected by the Failure to Supply. Any indemnification payment made to Chiesi under this paragraph for Failure to Supply shall be reimbursed in full to uniQure, in case any patient who suffered from the Failure to Supply is then subsequently treated. Such indemnification payments and reimbursements, if any, shall be calculated on a calendar year basis, such calculation to be made within [**] days after the end of the corresponding calendar year and any resulting amount to be paid within [**] days after such calculation has been made. uniQure, in relying on the above Force Majeure Event exceptions, shall provide reasonably detailed particulars of the reasons underlying any such Force Majeure Event to Chiesi and shall allocate its existing stocks of the Product between uniQure, its Affiliates, Chiesi and other distributors of the Product, on a proprevious 6-rata basis, based upon order volumes for the Product for the prior [**]month period.;
(c) For Following the purpose Parties’ acceptance of this an appropriate mechanism to cure the Default, Licensor shall use Diligent Efforts to implement such agreed upon mechanism. In the event that Licensor fails to begin the implementation of the agreed upon mechanism within 4 months of the Parties agreeing to such mechanism or fails to successfully complete the implementation of the agreed mechanism within 4 months of the Parties agreeing to such mechanism, then Licensee shall have the right to execute the Manufacturing Option set forth in Section 2.6, “Profit” shall be calculated, on a per Product basis, as the difference between (a) the relevant Average Net Sales Price that would have applied to the Product affected by the Failure to Supply and (b) the applicable Purchase Price for the Product affected by the Failure to Supply calculated as per Section 2.3 above, and “Lost Profit” shall mean the accumulated Profit for all quantities of Product affected by the Failure to Supply6.18 below.
Appears in 1 contract