Common use of Failure to Supply Clause in Contracts

Failure to Supply. 4.2.1 If Company becomes aware that a Supply Interruption is reasonably likely to occur, Company shall promptly notify AbbVie by telephone or by written notification and shall provide AbbVie with the opportunity to meet in person or by teleconference to discuss the details to the extent they are known by Company. 4.2.2 In the event that Company is unable, or notifies AbbVie that it is unable or otherwise receives notice from its CMO that it will be unable to supply, for any reason, except for a Force Majeure Event, to supply Product in accordance with the quantities and/or delivery dates specified by AbbVie for such Product via Purchase Orders, Company shall have a period of *** days or such longer time as necessary so long as Company is using commercially reasonable efforts to cure such interruption to supply, during which time Company will prioritize AbbVie Purchase Orders of Product over Company or other customer orders. If such interruption to supply continues after such sixty (60) day period, AbbVie may, in its sole discretion: (a) cancel outstanding Purchase Orders with Company; (b) require Company to supply the undelivered Product at a future date agreed upon by the Parties; or (c) at Company’s sole expense, manufacture or have manufactured by a Third Party designated and qualified by AbbVie such quantity of ribavirin as AbbVie may reasonably determine with notice to Company as will meet AbbVie’s worldwide requirements in light of such interruption to supply. AbbVie shall be entitled to receive from Company *** % of AbbVie’s cover damages, comprising cost differences between the Product’s cost and the replacement product’s cost, and reasonable costs associated with procuring replacements for the Product, until such time as Company is capable of resuming its supply obligations under this Agreement. Upon Company’s resolution of the interruption to supply to the reasonable satisfaction of AbbVie, AbbVie shall be required to resume purchasing the Applicable Percentage of AbbVie Product Requirements from Company but shall be excused from purchasing that portion attributable to the permitted purchases from the Third Party manufacturer under Section 4.2.2(c).

Appears in 3 contracts

Samples: License Agreement (Kadmon Holdings, LLC), Supply Agreement (Kadmon Holdings, LLC), Supply Agreement (Kadmon Holdings, LLC)

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Failure to Supply. 4.2.1 If Company becomes aware that IPC is unable (or anticipates an inability) to manufacture or deliver all or a Supply Interruption is reasonably likely portion of a Product to occurTris as required by a confirmed or accepted Purchase Order pursuant to Section 3.3 of this Agreement, Company IPC shall promptly notify AbbVie by telephone Tris in writing of the period for which such inability (or by written notification anticipated inability) to so manufacture or deliver is expected (an “Anticipated Inability to Deliver”). For avoidance of doubt, so long as IPC uses Commercially Reasonable Efforts and the anticipated inability is a force majeure event, IPC shall provide AbbVie with not be in breach of the opportunity Purchase Order(s) affected nor this Agreement, however, regardless of whether or not IPC has breached a Purchase Order or this Agreement it shall still be liable for Cover and the other obligations set forth in this Section 3.10. In the event IPC is unable to meet Tris’s Purchase Orders or IPC issues a notice of an Anticipated Inability to Deliver, IPC’s obligation to supply shall continue but Tris’ obligation to purchase the Product that IPC is unable to timely supply in person or accordance with Section 3.3 above shall be suspended and Tris, without relieving IPC of its obligations under Section 3.3, may mitigate its damages by teleconference purchasing from another Person the quantity of substitute product that it requires beyond what IPC is able to discuss deliver. Tris shall use Commercially Reasonable Efforts to obtain such substitute product at a reasonable price and communicate same to IPC in writing. Tris shall be entitled to deduct the details difference in cost paid by Tris for such substitute product over the cost of the Product (“Cover”), if any, from any amounts otherwise payable to IPC hereunder, and, to the extent they are known not so offset, IPC shall reimburse Tris for such Cover , within thirty (30) days of receipt of invoice from Tris. IPC will not be entitled to any share of positive Net Profits for sale of substitute product not sourced by Company. 4.2.2 In Tris from IPC hereunder (provided IPC shall continue to fund its share of negative Net Profits), except to the event that Company extent IPC has fully reimbursed Tris for the Cover expense with respect to such product. If at any time thereafter during the Term, IPC is unableable to timely deliver Product in satisfaction of Tris’ Purchase Orders, or notifies AbbVie that IPC shall so notify Tris in writing and, subject to Tris’ contractual commitments to third parties, Tris shall undertake commercially reasonable efforts to limit such contractual commitment in order not to exceed IPC’s volume and period it is unable or otherwise receives notice from its CMO that it will be unable to supply, Tris will resume purchasing the Product from IPC. If IPC’s inability to timely deliver to Tris the quantity of the Product described in this Section 3.3 continues for a period beyond three (3) months, Tris may terminate this Agreement upon thirty (30) days’ notice in writing to IPC. IPC shall reimburse Tris for any reason, except for a Force Majeure Event, failure to supply and late supply penalties and/or damages charged to Tris for late supply or non-supply caused by IPC’s failure to timely supply Product pursuant to Purchase Orders delivered to IPC in accordance with the quantities and/or delivery dates specified by AbbVie for such Product via Purchase Orders, Company shall have a period of *** days or such longer time as necessary so long as Company is using commercially reasonable efforts to cure such interruption to supply, during which time Company will prioritize AbbVie Purchase Orders of Product over Company or other customer orders. If such interruption to supply continues after such sixty (60) day period, AbbVie may, in its sole discretion: (a) cancel outstanding Purchase Orders with Company; (b) require Company to supply the undelivered Product at a future date agreed upon by the Parties; or (c) at Company’s sole expense, manufacture or have manufactured by a Third Party designated and qualified by AbbVie such quantity of ribavirin as AbbVie may reasonably determine with notice to Company as will meet AbbVie’s worldwide requirements in light of such interruption to supply. AbbVie shall be entitled to receive from Company *** % of AbbVie’s cover damages, comprising cost differences between the Product’s cost and the replacement product’s cost, and reasonable costs associated with procuring replacements for the Product, until such time as Company is capable of resuming its supply obligations under this Agreement. Upon Company’s resolution of the interruption For clarity and audit purposes, such failure to supply to the reasonable satisfaction of AbbVie, AbbVie penalties shall be required supported by appropriate invoices detailing the failure to resume purchasing supply penalties issued by the Applicable Percentage affected customers and wholesallers of AbbVie Product Requirements Tris. IPC shall reimburse Tris for such penalties and damages, within ten (10) days of receipt of invoice for same from Company but shall be excused from purchasing Tris, provided that portion attributable if such invoice is not timely paid, Tris may at its option offset such amounts owed against other amounts payable by Tris to the permitted purchases from the Third Party manufacturer under Section 4.2.2(c)IPC.

Appears in 3 contracts

Samples: License and Commercial Supply Agreement (Intellipharmaceutics International Inc.), License and Commercial Supply Agreement (Intellipharmaceutics International Inc.), License and Commercial Supply Agreement (Intellipharmaceutics International Inc.)

Failure to Supply. 4.2.1 If Company becomes aware that a Supply Interruption is reasonably likely to occurELITE shall notify LANNETT as promptly as possible, Company shall promptly notify AbbVie by telephone or by written notification and shall provide AbbVie with the opportunity to meet but in person or by teleconference to discuss the details to the extent they are known by Company. 4.2.2 In the no event that Company is unablelater than five (5) Business Days, or notifies AbbVie that it is unable or otherwise receives notice from its CMO after ELITE discovers that it will not be unable able to supply the quantity of Products ordered by the delivery date specified in a Purchase Order. In such event: (i) ELITE shall cooperate with LANNETT in taking all actions that XXXXXXX xxxxx reasonably necessary in order to remedy such inability to supply, for any reason, except for a Force Majeure Event, at ELITE’s expense; and (ii) If ELITE’s inability to supply Product continues past twenty (20) days from the required delivery date set forth in accordance with the quantities and/or delivery dates specified by AbbVie for Purchase Order at LANNETT’s election, any or all outstanding Purchase Orders relating to such Product via may be cancelled and LANNETT shall have no obligations with respect to such Purchase Orders; provided, Company however, ELITE must cover any Failure to Supply (as defined below) obligations set forth in this Section. Compliance by ELITE with this Article 4.4 shall have not relieve ELITE of any other obligation or liability under this Agreement. LANNETT shall otherwise retain all of its rights under this Agreement and/or at law against ELITE for its failure to deliver all or any portion of the quantity of Products ordered by LANNETT. With regards to a period Binding Forecast or if ELITE accepted a Purchase Order from LANNETT, pursuant to the procedures defined in Section 4.2 of *** days this Agreement, then ELITE shall be responsible for the late charges and any penalties assessed against LANNETT by its Customers or such longer time as necessary so long as Company any other third party or any costs, fees, charges, or penalties incurred by Lannett (“Failure to Supply”), unless the delay is using attributable to (i) action or controls imposed by the DEA that do not result from ELITE's negligence, gross negligence or willful misconduct; or (ii) demonstrable raw material shortages that are beyond ELITE's control, but ELITE will use commercially reasonable efforts to cure such interruption keep three (3) to supply, during which time Company will prioritize AbbVie Purchase Orders six (6) months of Product over Company or other customer ordersraw materials inventory on hand at all times. If such interruption to supply continues after such sixty (60) day period, AbbVie may, in its sole discretion: (a) cancel outstanding Purchase Orders with Company; (b) require Company to supply the undelivered Product at a future date agreed upon Late charges and any penalties assessed against ELITE by the Parties; or (c) at Company’s sole expense, manufacture or have manufactured by a Third Party designated and qualified by AbbVie such quantity of ribavirin as AbbVie may reasonably determine with notice to Company as will meet AbbVie’s worldwide requirements in light of such interruption to supply. AbbVie shall be entitled to receive from Company *** % of AbbVie’s cover damages, comprising cost differences between the Product’s cost and the replacement product’s cost, and reasonable costs associated with procuring replacements for the Product, until such time as Company is capable of resuming its supply obligations LANNETT under this Agreement. Upon Company’s resolution paragraph are due and payable within thirty (30) days of the interruption being invoiced by LANNETT and, if not timely paid, may be deducted against amounts owed by LANNETT to supply to the reasonable satisfaction of AbbVie, AbbVie shall be required to resume purchasing the Applicable Percentage of AbbVie Product Requirements from Company but shall be excused from purchasing that portion attributable to the permitted purchases from the Third Party manufacturer under Section 4.2.2(c)ELITE.

Appears in 2 contracts

Samples: License, Supply and Distribution Agreement (Elite Pharmaceuticals Inc /Nv/), License, Supply and Distribution Agreement (Elite Pharmaceuticals Inc /Nv/)

Failure to Supply. 4.2.1 If Company becomes aware Notwithstanding the provisions of Section 7.02, in the event that Diametrics shall be unable or unwilling or has failed for any reason (including as a Supply Interruption is reasonably likely result of the commencement of a case by or against Diametrics under Title 11 (as defined in Section 9.02)) to occur, Company shall promptly notify AbbVie by telephone or by written notification and shall provide AbbVie supply to JJPI any Products in compliance with the opportunity to meet desired delivery date specified in person or the purchase orders submitted by teleconference to discuss the details JJPI in accordance with Section 2.05 hereof (to the extent they are known by Company. 4.2.2 In such quantities were included within the event that Company is unable, or notifies AbbVie that it is unable or otherwise receives notice from its CMO that it will be unable to supply, for any reason, except for a Force Majeure Event, to supply Product relevant forecasts submitted in accordance with the quantities and/or delivery dates specified by AbbVie for such Product via Purchase OrdersSection 2.04 hereof) (a "Failure to Supply"), Company shall have a period of *** then, upon ninety (90) days or such longer time as necessary so long as Company is using commercially reasonable efforts written notice from JJPI (if Diametrics has failed to cure the breach during such interruption to supply, during which time Company will prioritize AbbVie Purchase Orders of Product over Company or other customer orders. If such interruption to supply continues after such sixty ninety (6090) day period, AbbVie maywhich cure may include the use of a third party manufacturer of Products that has satisfied the JJPI's Supplier Qualification Activities), JJPI may use, sell, make and have made the Products and use the Diametrics Trademarks in its sole discretion: (a) cancel outstanding Purchase Orders with Company; (b) require Company connection therewith pursuant to supply the undelivered Product at a future date agreed upon by the Parties; or (c) at Company’s sole expense, manufacture or have manufactured by a Third Party designated and qualified by AbbVie such quantity of ribavirin as AbbVie may reasonably determine with notice to Company as will meet AbbVie’s worldwide requirements license granted in light of such interruption to supply. AbbVie shall be entitled to receive from Company *** % of AbbVie’s cover damages, comprising cost differences between the Product’s cost and the replacement product’s cost, and reasonable costs associated with procuring replacements for the Product, Section 9.01 until such time as Company is capable of resuming Diametrics demonstrates to JJPI's reasonable satisfaction its ability to fully resume its supply obligations hereunder (such time period, a "License Period"); provided that JJPI shall have no obligation to purchase Products from Diametrics, and the License Period shall continue, until the earlier of (i) any contractual obligations that JJPI has assumed in connection with producing the same or obtaining such substitute source of supply shall have terminated, and (ii) 180 days following the date on which Diametrics demonstrates to JJPI's reasonable satisfaction its ability to fully resume its supply obligations hereunder. In the event of such Failure to Supply, Diametrics shall make available to JJPI or its designee access to all Know-How and any other technical and proprietary materials, information and techniques necessary or helpful for JJPI to procure required raw materials or produce or arrange an alternative supplier of Product, and to provide advice and consultation in connection therewith. Diametrics shall not sell any Product to any third party during a License Period. JJPI shall pay to Diametrics a royalty equal to (***)% of Net Sales of Product manufactured by or for JJPI under this Article 7 which, but for the license granted in Article 9 of this Agreement, would infringe a valid claim of a Diametrics Patent, and a royalty equal to (***)% of Net Sales of Product manufactured by or for JJPI under this Article 7 which do not infringe a valid claim of a Diametrics Patent. Upon Company’s resolution The provisions of this Section 7.01 shall constitute JJPI's sole and exclusive remedy for a Failure to Supply except to the extent such Failure to Supply is attributable to an intentional or willful act, omission or decision by Diametrics. -------- ***Denotes confidential information that has been omitted from the exhibit and filed separately, accompanied by a confidential treatment request, with the Securities and Exchange Commission pursuant to Rule 24b-2 of the interruption to supply to the reasonable satisfaction Securities Exchange Act of AbbVie, AbbVie shall be required to resume purchasing the Applicable Percentage of AbbVie Product Requirements from Company but shall be excused from purchasing that portion attributable to the permitted purchases from the Third Party manufacturer under Section 4.2.2(c)1934.

Appears in 2 contracts

Samples: Distribution Agreement (Diametrics Medical Inc), Distribution Agreement (Diametrics Medical Inc)

Failure to Supply. 4.2.1 If Company becomes aware that a Supply Interruption is reasonably likely to occur, Company shall promptly notify AbbVie by telephone or by written notification and shall provide AbbVie with the opportunity to meet in person or by teleconference to discuss the details to the extent they are known by Company. 4.2.2 (a) In the event that Company is unable, or notifies AbbVie that it is unable or otherwise receives notice from its CMO becomes apparent to uniQure that it will be unable to supplyfulfill 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 reasonsuch 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 for if such Failure to Supply is caused as a result of any Force Majeure Event, to supply Product in accordance with the quantities and/or delivery dates specified by AbbVie for such Product via Purchase Orders, Company shall have a period of *** days or such longer time as necessary so long as Company is using commercially reasonable efforts to cure such interruption to supply, during which time Company will prioritize AbbVie Purchase Orders of Product over Company or other customer orders. If such interruption to supply continues after such sixty (60) day period, AbbVie may, in its sole discretion: (a) cancel outstanding Purchase Orders with Company; (b) require Company to supply the undelivered Product at a future date agreed upon by the Parties; or (c) at Company’s sole expense, manufacture or have manufactured by a Third Party designated and qualified by AbbVie such quantity of ribavirin as AbbVie may reasonably determine with notice to Company as will meet AbbVie’s worldwide requirements in light of such interruption to supply. AbbVie then Chiesi shall be entitled to receive 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 Company 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 AbbVie’s cover damagesthe corresponding calendar year and any resulting amount to be paid within [**] days after such calculation has been made. uniQure, comprising cost differences 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 the Product’s cost uniQure, its Affiliates, Chiesi and the replacement product’s cost, and reasonable costs associated with procuring replacements for other distributors of the Product, until such time 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 Company is capable of resuming its supply obligations under this Agreement. Upon Company’s resolution of the interruption to supply difference between (a) the relevant Average Net Sales Price that would have applied to the reasonable satisfaction 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 AbbVie, AbbVie shall be required Product affected by the Failure to resume purchasing the Applicable Percentage of AbbVie Product Requirements from Company but shall be excused from purchasing that portion attributable to the permitted purchases from the Third Party manufacturer under Section 4.2.2(c)Supply.

Appears in 2 contracts

Samples: Commercialization Agreement (uniQure B.V.), Commercialization Agreement (uniQure B.V.)

Failure to Supply. 4.2.1 If Company becomes aware Subject to Section 15.1, if SHEARWATER cannot supply at least seventy-five percent (75%) of the amount of the REAGENT consistent with and at the times specified by Sections 4.3 and 4.4 and does not cure the deficiency within ninety (90) days after EYETECH so notifies SHEARWATER in writing that a Supply Interruption is reasonably likely portion of the REAGENT due for delivery has not been delivered, after using all reasonable efforts, then SHEARWATER will be considered as being unable to occurmanufacture and sell to EYETECH the REAGENT under this AGREEMENT ("FAILURE"). In the case of a FAILURE for any reason, Company shall promptly notify AbbVie SHEARWATER shall, subject to this Section 4.7, immediately work with EYETECH and grant to one THIRD PARTY contract manufacturer (the "CONTRACT MANUFACTURER" such CONTRACT MANUFACTURER being subject to approval by telephone EYETECH, such approval to not be unreasonably withheld) a personal, non-assignable, non-exclusive right and license under the LICENSED TECHNOLOGY to make the amount of REAGENT, for the sole purpose of EYETECH producing the PRODUCT, in accordance with EYETECH'S order for the relevant calendar quarter as well as during the following three (3) calendar quarters or such longer period if required to fully address the FAILURE in accordance with Section 4.8. Such FAILURE by written notification and shall provide AbbVie SHEARWATER to supply EYETECH with the opportunity REAGENT will not be taken as a refusal by SHEARWATER to meet supply EYETECH with the REAGENT for subsequent calendar quarters unless SHEARWATER so indicates. With respect to such subsequent calendar quarters, if SHEARWATER has demonstrated that it has the ability to supply all of EYETECH'S REAGENT requirements hereunder, EYETECH will resume purchases of the REAGENT from SHEARWATER in person or the manner provided for by teleconference to discuss the details this AGREEMENT. Payments made by EYETECH to the extent they are known CONTRACT MANUFACTURER for REAGENT supplied during a FAILURE shall be recognized by Company. 4.2.2 In SHEARWATER, and SHEARWATER shall not seek payment for such supply. Notwithstanding the event that Company is unableforegoing, or notifies AbbVie that it is unable or otherwise receives notice from its CMO that it will be unable to supplyall of EYETECH'S milestone and royalty obligations shall remain in effect during the period of any FAILURE. If SHEARWATER, for any reason, except for a Force Majeure Event, shall on two (2) separate occasions FAIL under this Section 4.7 to supply Product in accordance EYETECH with the quantities and/or delivery dates specified by AbbVie for such Product via Purchase OrdersREAGENT, Company EYETECH shall have a period thereafter be allowed to purchase from the CONTRACT MANUFACTURER all of *** days or such longer time as necessary so long as Company is using commercially reasonable efforts its future requirements of the REAGENT without regard to cure such interruption to supply, during which time Company will prioritize AbbVie Purchase Orders of Product over Company or other customer orders. If such interruption SHEARWATER'S willingness and ability to supply continues after such sixty (60) day period, AbbVie may, in EYETECH with its sole discretion: (a) cancel outstanding Purchase Orders with Company; (b) require Company to supply the undelivered Product at a future date agreed upon by the Parties; or (c) at Company’s sole expense, manufacture or have manufactured by a Third Party designated and qualified by AbbVie such quantity of ribavirin as AbbVie may reasonably determine with notice to Company as will meet AbbVie’s worldwide requirements in light of such interruption to supply. AbbVie shall be entitled to receive from Company *** % of AbbVie’s cover damages, comprising cost differences between the Product’s cost and the replacement product’s cost, and reasonable costs associated with procuring replacements for the Product, until such time as Company is capable of resuming its supply obligations under this Agreement. Upon Company’s resolution of the interruption to supply to the reasonable satisfaction of AbbVie, AbbVie shall be required to resume purchasing the Applicable Percentage of AbbVie Product Requirements from Company but shall be excused from purchasing that portion attributable to the permitted purchases from the Third Party manufacturer under Section 4.2.2(c)REAGENT.

Appears in 2 contracts

Samples: License, Manufacturing and Supply Agreement (Osi Pharmaceuticals Inc), License, Manufacturing and Supply Agreement (Eyetech Pharmaceuticals Inc)

Failure to Supply. 4.2.1 If Company becomes aware 8.1 In the event of any Short Term Inability to Supply the Product in the Territory, Immuron shall be liable to Paladin for its foregone Net Sales from Paladin’s binding forecast during the period of time that a Supply Interruption is Paladin did not have Product to sell by reason of the said Inability to Supply. Paladin shall attempt to quantify the financial impact of any Short Term Inability to Supply, in writing, as soon as reasonably likely possible to occur, Company shall promptly notify AbbVie by telephone or by written notification Immuron and shall provide AbbVie with the opportunity use all reasonable efforts to meet in person or by teleconference to discuss the details to the extent they are known by Company. 4.2.2 mitigate such impact. Payments due under this Section 8.1 shall be payable within thirty (30) days of receipt of said claim. In the event that Company is unabletwo (2) Short Term Inability to Supply events occur within a six (6) month period, or notifies AbbVie that it is unable or otherwise receives notice from its CMO that it will then Immuron shall, upon Paladin’s request, be unable required to supplyenter into a contract manufacturing agreement with an approved manufacturer of the Product, for as set forth in Section 8.3 below, at Immuron’s expense. 8.2 In the event of any reason, except for a Force Majeure Event, Long Term Inability to supply Supply the Product in accordance with the quantities and/or delivery dates specified by AbbVie for such Product via Purchase OrdersTerritory, Company shall have a period of *** days or such longer time as necessary so long as Company is using the parties agree to act in good faith and make all commercially reasonable efforts to cure find a mutually acceptable solution to the Long Term Inability to Supply. Notwithstanding the above, Immuron shall be liable for payments to Paladin as follows: Paladin’s foregone Net Sales from Paladin’s binding forecast during the period of time that Paladin did not have Product to sell by reason of the said Inability to Supply; provided that all outstanding sales (including orders received but not yet processed or shipped) and backorders (not exceeding the frame of the current forecast) due to such interruption Long Term Inability to supply, during which time Company will prioritize AbbVie Purchase Orders Supply are included in the calculation of Product over Company or other customer ordersNet Sales for such period. If Payments due under this Section 8.2 shall be payable within thirty (30) days of receipt of said claim (such interruption claim to supply continues after such sixty (60) day period, AbbVie maybe made without delay). 8.3 In addition, in its sole discretion: the event of (i) a Long Term Inability to Supply or the (ii) circumstances set out in Section 8.2, or (iii) the happening of any of the events set out in Sections 13.1(c) to 13.1(e) in respect of Immuron, Paladin shall be entitled, by notice in writing to terminate the supply arrangements contemplated in this Agreement, in which event: (a) cancel outstanding Purchase Orders with Company; (b) require Company to supply the undelivered Product at a future date agreed upon by the Parties; or (c) at Company’s sole expense, manufacture or have manufactured by a Third Party designated and qualified by AbbVie such quantity of ribavirin as AbbVie may reasonably determine with notice to Company as will meet AbbVie’s worldwide requirements in light of such interruption to supply. AbbVie Paladin shall be entitled to receive purchase the Product directly from Company *** % an approved manufacturer of AbbVie’s cover damages, comprising cost differences between the Product’s cost . Upon request from Paladin, Immuron shall deliver to each approved manufacturer of the Product a form of letter (in form and substance acceptable to Paladin acting reasonably) permitting Paladin to acquire the replacement product’s costProduct directly from that manufacturer, and reasonable costs associated with procuring replacements Immuron shall procure that such manufacturer shall agree to supply same, in the circumstances contemplated by this Agreement and upon notice from Paladin. Immuron shall arrange for such an agreement from each newly approved manufacturer. Immuron hereby grants to Paladin the Product, until such time as Company is capable of resuming its supply obligations under this Agreement. Upon Company’s resolution nonexclusive license to use the Immuron IP for or in respect of the interruption manufacture of the Product in such circumstances. (b) Immuron shall provide such assistance as is requested by Paladin, acting reasonably, from time to supply time to assist in sourcing the reasonable satisfaction of AbbVie, AbbVie shall be required to resume purchasing the Applicable Percentage of AbbVie Product Requirements from Company but shall be excused from purchasing that portion attributable to the permitted purchases from the Third Party manufacturer under Section 4.2.2(c)a third party.

Appears in 2 contracts

Samples: Distribution and License Agreement (Immuron LTD), Distribution and License Agreement (Immuron LTD)

Failure to Supply. 4.2.1 If Company becomes aware Subject to Section 14.1, if NEKTAR cannot supply at least [**] percent ([**]%) of the amount of the REAGENT consistent with and at the times specified by Sections 4.3 and 4.4 and does not cure the deficiency within [**] days after OPHTHOTECH so notifies NEKTAR in writing that a Supply Interruption is reasonably likely portion of the REAGENT due for delivery has not been delivered, after using all reasonable efforts, then NEKTAR will be considered as being unable to occur, Company shall promptly notify AbbVie by telephone or by written notification manufacture and shall provide AbbVie with sell to OPHTHOTECH the opportunity to meet in person or by teleconference to discuss the details to the extent they are known by Company. 4.2.2 REAGENT under this AGREEMENT (“FAILURE”). In the event that Company is unable, or notifies AbbVie that it is unable or otherwise receives notice from its CMO that it will be unable to supply, case of a FAILURE for any reason, except NEKTAR shall, subject to this Section 4.7, immediately work with OPHTHOTECH and grant to one THIRD PARTY contract manufacturer (the “CONTRACT MANUFACTURER” such CONTRACT MANUFACTURER being subject to approval by both OPHTHOTECH and NEKTAR, such approval to not be unreasonably withheld by either party) a personal, non-assignable, non-exclusive right and license under the LICENSED TECHNOLOGY to make the amount of REAGENT, for a Force Majeure Eventthe sole purpose of OPHTHOTECH producing the PRODUCT, to supply Product in accordance with OPHTHOTECH’s order for the quantities and/or delivery dates specified relevant CALENDAR QUARTER as well as during the following [**] CALENDAR QUARTERS [**]. Such FAILURE by AbbVie NEKTAR to supply OPHTHOTECH with the REAGENT will not be taken as a refusal by NEKTAR to supply OPHTHOTECH with the REAGENT for subsequent CALENDAR QUARTERS unless NEKTAR so indicates. With respect to such subsequent CALENDAR QUARTERS, if NEKTAR has demonstrated that it has the ability to supply all of OPHTHOTECH’s REAGENT requirements hereunder, OPHTHOTECH will resume purchases of the REAGENT from NEKTAR in the manner provided for by this AGREEMENT. Payments made by OPHTHOTECH to the CONTRACT MANUFACTURER for REAGENT supplied during a FAILURE shall be recognized by NEKTAR, and NEKTAR shall not seek payment for such Product via Purchase Orderssupply. Notwithstanding the foregoing, Company all of OPHTHOTECH’s milestone and royalty obligations shall have a remain in effect during the period of any FAILURE. [*** days or such longer time as necessary so long as Company is using commercially reasonable efforts to cure such interruption to supply, during which time Company will prioritize AbbVie Purchase Orders of Product over Company or other customer orders. If such interruption to supply continues after such sixty (60) day period, AbbVie may, in its sole discretion: (a) cancel outstanding Purchase Orders with Company; (b) require Company to supply the undelivered Product at a future date agreed upon by the Parties; or (c) at Company’s sole expense, manufacture or have manufactured by a Third Party designated and qualified by AbbVie such quantity of ribavirin as AbbVie may reasonably determine with notice to Company as will meet AbbVie’s worldwide requirements in light of such interruption to supply. AbbVie shall be entitled to receive from Company *** % of AbbVie’s cover damages, comprising cost differences between the Product’s cost and the replacement product’s cost, and reasonable costs associated with procuring replacements for the Product, until such time as Company is capable of resuming its supply obligations under this Agreement. Upon Company’s resolution of the interruption to supply to the reasonable satisfaction of AbbVie, AbbVie shall be required to resume purchasing the Applicable Percentage of AbbVie Product Requirements from Company but shall be excused from purchasing that portion attributable to the permitted purchases from the Third Party manufacturer under Section 4.2.2(c)].

Appears in 2 contracts

Samples: License, Manufacturing and Supply Agreement (Ophthotech Corp.), License, Manufacturing and Supply Agreement (Ophthotech Corp.)

Failure to Supply. 4.2.1 If Company becomes aware that a Supply Interruption is reasonably likely to occurELITE shall notify GLENMARK as promptly as possible, Company shall promptly notify AbbVie by telephone or by written notification and shall provide AbbVie with the opportunity to meet but in person or by teleconference to discuss the details to the extent they are known by Company. 4.2.2 In the no event that Company is unablelater than five (5) Business Days, or notifies AbbVie that it is unable or otherwise receives notice from its CMO after ELITE discovers that it will not be unable able to supply the quantity of Products ordered by the delivery date specified in a Purchase Order. In such event: (i) ELITE shall cooperate with GLENMARK in taking all actions that GLENMARK deems reasonably necessary in order to remedy such inability to supply, for any reason, except for a Force Majeure Event, to supply Product in accordance with the quantities and/or delivery dates specified by AbbVie for such Product via Purchase Orders, Company shall have a period of *** days or such longer time as necessary so long as Company is using commercially reasonable efforts to cure such interruption to supply, during which time Company will prioritize AbbVie Purchase Orders of Product over Company or other customer orders. at ELITE’s expense; and (ii) If such interruption ELITE’s inability to supply continues after past twenty (20) days from the required delivery date set forth in the Purchase Order at GLENMARK’s election, any or all outstanding Purchase Orders relating to such sixty Product may be cancelled and GLENMARK shall have no obligations with respect to such Purchase Orders. Compliance by ELITE with this Article 4.4 shall not relieve ELITE of any other obligation or liability under this Agreement. GLENMARK shall otherwise retain all of its rights under this Agreement and/or at law against ELITE for its failure to deliver all or any portion of the quantity of Products ordered by GLENMARK. If ELITE’s inability to supply continues past twenty (6020) day perioddays from the required delivery date set forth in the Purchase Order, AbbVie GLENMARK may, in its sole discretion: , elect to terminate this Agreement immediately upon written notice to ELITE. With regards to a Binding Forecast or if ELITE accepted a Purchase Order from GLENMARK, pursuant to the procedures defined in Section 4.2 of this Agreement, then ELITE shall be responsible for the late charges and any penalties assessed against GLENMARK by its Customers, unless the delay is attributable to (ai) cancel outstanding Purchase Orders with Company; (b) require Company to supply the undelivered Product at a future date agreed upon action or controls imposed by the PartiesDEA that do not result from ELITE's negligence; or (cii) at Company’s sole expense, manufacture or have manufactured demonstrable raw material shortages that are beyond ELITE's control. Late charges and any penalties assessed against ELITE by a Third Party designated and qualified by AbbVie such quantity of ribavirin as AbbVie may reasonably determine with notice to Company as will meet AbbVie’s worldwide requirements in light of such interruption to supply. AbbVie shall be entitled to receive from Company *** % of AbbVie’s cover damages, comprising cost differences between the Product’s cost and the replacement product’s cost, and reasonable costs associated with procuring replacements for the Product, until such time as Company is capable of resuming its supply obligations GLENMARK under this Agreement. Upon Company’s resolution paragraph are due and payable within thirty (30) days of the interruption being invoiced by GLENMARK and, if not timely paid, may be deducted against amounts owed by GLENMARK to supply to the reasonable satisfaction of AbbVie, AbbVie shall be required to resume purchasing the Applicable Percentage of AbbVie Product Requirements from Company but shall be excused from purchasing that portion attributable to the permitted purchases from the Third Party manufacturer under Section 4.2.2(c)ELITE.

Appears in 1 contract

Samples: License, Supply and Distribution Agreement (Elite Pharmaceuticals Inc /Nv/)

Failure to Supply. 4.2.1 If Company becomes aware (A) Notwithstanding the provisions of Section 9.1 (Force Majeure Events), in the event that SNBTS shall be unable or unwilling or shall fail to supply any Product which conforms to the Product Requirements in such quantities as OCD shall request and in compliance with the delivery periods set forth in Article 6.0 (Forecasts and Ordering) (hereinafter referred to as a Supply Interruption “Failure to Supply”), then the following provisions shall apply: (1) during the initial ninety (90) days of any Failure to Supply, SNBTS shall use its best efforts to resume its supply obligations hereunder and, at its sole option, shall have the right to either: (A) designate a third-party manufacturer of the Products that is reasonably likely approved in writing by OCD (such approval not to occurbe unreasonably withheld) and license to or otherwise make available to such approved third-party manufacturer all Know How and any other technical and proprietary materials, Company shall promptly notify AbbVie by telephone intellectual property, information and techniques necessary or helpful for such third-party manufacturer to procure required raw materials, including the documents held in escrow pursuant to Section 9.3 below; or (B) by written notification notice to OCD, activate the Licenses granted pursuant to Section 9.4 of this Umbrella Agreement and make available to OCD or an alternative supplier designated by OCD and approved in writing by SNBTS (such approval not to be unreasonably withheld) all Know How and any other technical and proprietary materials, intellectual property, information and techniques necessary or helpful for OCD or its designee to procure required raw materials or to produce Products, including the documents held in escrow pursuant to Section 9.3 below. Ortho-Clinical Diagnostics, Inc. / SNBTS Proprietary Information (2) if SNBTS has not resumed its supply obligations within ninety (90) days after the commencement of a Failure to Supply and: (A) OCD has not received Products by such date from an approved third-party manufacturer designated by SNBTS or has not had its Licenses activated by SNBTS by such date and (B) after consultation between SNBTS and OCD, SNBTS has failed to demonstrate to OCD’s satisfaction likely prospects of success at either ending the Failure to Supply or securing an alternative supply of Products to OCD and OCD determines in its sole discretion that it can more quickly secure such alternative supplies by acting in accordance with clause (B) of the paragraph above, then upon written notice to SNBTS by OCD the Licenses shall provide AbbVie be deemed activated and the provisions of clause (B) of the paragraph above shall apply. (B) OCD shall have no obligation to purchase Products from SNBTS for the duration of any Failure to Supply and until any contractual obligations that OCD has assumed in connection with the opportunity producing Products or obtaining them from a substitute source of supply shall have terminated. OCD shall have no obligation to meet in person or by teleconference to discuss the details affirmatively terminate any such contractual arrangement; provided, however, that OCD shall, to the extent they are known by Companythat it is commercially reasonable, make a good faith effort to limit such contractual obligations to the anticipated duration and scope of such Failure to Supply. 4.2.2 In (C) Notwithstanding anything to the contrary contained in this Umbrella Agreement, in the event that Company OCD shall make or have made the Products, pursuant to this Section 9.2, OCD shall be permitted to disclose to any third party any Confidential Information as is unablereasonably necessary in connection with such activities (subject to such third party agreeing in writing to be bound by the terms of Section 21.1 (Confidential Information) hereof). (D) Notwithstanding the foregoing provisions of this Section 9.2, if such inability, unwillingness or notifies AbbVie that it is unable or otherwise receives notice from its CMO that it will be unable to supply, for any reason, except for a Force Majeure Event, failure to supply Product in accordance Products which conform with the quantities and/or applicable Product Requirements within the delivery dates specified by AbbVie for period set forth herein occurs more than once in any calendar quarter such Product via Purchase Ordersinability, Company shall have a period of *** days unwillingness or such longer time as necessary so long as Company is using commercially reasonable efforts to cure such interruption to supply, during which time Company will prioritize AbbVie Purchase Orders of Product over Company or other customer orders. If such interruption to supply continues after such sixty (60) day period, AbbVie may, in its sole discretion: (a) cancel outstanding Purchase Orders with Company; (b) require Company to supply the undelivered Product at a future date agreed upon by the Parties; or (c) at Company’s sole expense, manufacture or have manufactured by a Third Party designated and qualified by AbbVie such quantity of ribavirin as AbbVie may reasonably determine with notice to Company as will meet AbbVie’s worldwide requirements in light of such interruption to supply. AbbVie failure shall be entitled to receive from Company *** % deemed a material breach of AbbVie’s cover damages, comprising cost differences between the Product’s cost and the replacement product’s cost, and reasonable costs associated with procuring replacements for the Product, until such time as Company is capable of resuming its supply obligations under this Umbrella Agreement. Upon Company’s resolution of the interruption to supply to the reasonable satisfaction of AbbVie, AbbVie shall be required to resume purchasing the Applicable Percentage of AbbVie Product Requirements from Company but shall be excused from purchasing that portion attributable to the permitted purchases from the Third Party manufacturer under Section 4.2.2(c).

Appears in 1 contract

Samples: Supply Umbrella Agreement

Failure to Supply. 4.2.1 If Company becomes aware ArthroCare’s obligations for maintaining continuity of supply are set forth in Article 3 hereof (the Performance Requirement). A failure to supply with respect to any ArthroCare Manufactured Products to be manufactured by ArthroCare for Xxxxx & Nephew under this Agreement shall be deemed to have occurred if, after the Effective Date of this Agreement, and after it has been mutually determined by the Parties that a Supply Interruption is reasonably likely cannot or will not be mitigated through the Business Continuity Plan and a Disaster Recovery Plan to occur, Company shall promptly notify AbbVie by telephone or by written notification and shall provide AbbVie with the opportunity be developed pursuant to meet in person or by teleconference to discuss the details to the extent they are known by Company.Section 3.2(d) of this Agreement: 4.2.2 In the event that Company (i) ArthroCare is unable, unwilling or notifies AbbVie that it is unable or otherwise receives notice from its CMO that it will be unable to supply, has failed for any reason, except for reason (excluding the occurrence of a Force Majeure Event, Event or the inability by ArthroCare and Xxxxx & Nephew to agree on product specifications and process development responsibility) to supply Product to Xxxxx & Nephew at least the following percentages of Licensed OEM Products or Non-Licensed OEM Products (for such products that have been manufactured by ArthroCare for at least [*]) (“Category of Product” for this Section 7.1 only) conforming in all material respects with the applicable Specifications therefor in compliance with ArthroCare’s delivery obligations set forth in Article 3 for purchase orders submitted by Xxxxx & Nephew and accepted by ArthroCare in accordance with Article 3 for the quantities and/or delivery dates specified by AbbVie following periods of time: (A) [*] of any Category of Products for such Product via Purchase Orders[*] consecutive days, Company shall have or (B) [*] of any Category of Products for [*] consecutive days, or (ii) ArthroCare becomes the subject of a period Bankruptcy Event (each of *** days or such longer time as necessary so long as Company is using commercially reasonable efforts the events in subparagraph (i) above and this subparagraph (ii) a “Failure to cure such interruption to supply, during which time Company will prioritize AbbVie Purchase Orders of Product over Company or other customer orders. If such interruption to supply continues after such sixty (60) day period, AbbVie may, in its sole discretion: (a) cancel outstanding Purchase Orders with CompanySupply”); and (b) require Company such Failure to supply Supply is not cured by ArthroCare within [*] days after receipt of written notice from Xxxxx & Nephew specifying that a Failure to Supply pursuant to Section 7.1(a)(i) has occurred, or immediately if such Failure to Supply constitutes Failure to Supply pursuant to Section 7.1(a)(ii), then, subject to Section 7.3 below: (i) if the undelivered Product at a future date agreed upon Failure to Supply is with respect to any Licensed OEM Products, Xxxxx & Nephew may make or have made such Licensed OEM Product(s) pursuant to the limited license granted by ArthroCare to Xxxxx & Nephew under Section 7.2 below only until such time that ArthroCare cures such Failure to Supply; (ii) Xxxxx & Nephew shall have no obligation to purchase any further ArthroCare Manufactured Products that are the Parties; or subject of such Failure to Supply from ArthroCare until such time that ArthroCare cures such Failure to Supply, and (ciii) at Company’s sole expenseArthroCare shall provide such assistance, training and other information as shall be reasonably necessary in order for Xxxxx & Nephew to manufacture or have manufactured by a Third Party designated and qualified by AbbVie such quantity of ribavirin as AbbVie may reasonably determine with notice to Company as will meet AbbVie’s worldwide requirements in light the Licensed OEM Products or Non-Licensed OEM Products that are the subject of such interruption Failure to supply. AbbVie shall be entitled to receive from Company *** % of AbbVie’s cover damagesSupply and shall, comprising cost differences between the Product’s cost and the replacement product’s cost, and reasonable costs associated with procuring replacements for the Product, until such time as Company is capable of resuming its supply obligations under this Agreement. Upon Company’s resolution of the interruption to supply subject to the reasonable satisfaction confidentiality obligations set forth in Section 13.1, disclose to Xxxxx & Nephew all technology necessary to manufacture or have manufactured such Licensed OEM Products or Non-Licensed OEM Products. For the purposes of AbbViethis Article, AbbVie “cured” shall be required to resume purchasing mean ArthroCare making up any shortfall in the Applicable Percentage supply of AbbVie Product Requirements from Company but shall be excused from purchasing that portion attributable relevant products during the period leading to the permitted purchases from the Third Party manufacturer under Failure to Supply. ArthroCare shall use reasonable commercial efforts to cure any Failure to Supply (even if challenged pursuant to Section 4.2.2(c)7.3 hereof) as quickly as possible.

Appears in 1 contract

Samples: Supply and Distribution Agreement (Arthrocare Corp)

Failure to Supply. 4.2.1 If, during any Contract Year, OSUR is unable for any reason (other than Distributor’s failure to comply with Section 4.2 or 4.5(b)) to supply at least *** in accordance with the terms and conditions of this Agreement, ordered by binding Purchase Orders in compliance with the terms of Section 4.5 (which quantity shall not include excess quantities contemplated by Section 4.5(a)(iv)) for delivery in any calendar quarter, and such failure continues for at least ninety (90) days after the delivery date set forth in such Purchase Order, then Distributor may elect to obtain a supply of a replacement product (the “Replacement Product”) from a third party (a “Third Party Supplier”) in an amount equal to the quantity of Product OSUR is unable to supply. Distributor shall notify OSUR in writing of its election no later than thirty (30) days after the end of the ninety (90) day period specified above. If Company becomes aware Distributor exercises its right under this Section 4.9, such action shall be Distributor’s sole and exclusive remedy in the event of a failure to supply OSUR. OSUR shall cooperate with Distributor in order to enable such Third Party Supplier to supply Replacement Product as required under this Section 4.9; provided that any such Third Party Supplier executes a confidentiality agreement in form and substance reasonably satisfactory to OSUR in order to maintain the confidentiality of any proprietary information provided by OSUR to such Third Party Supplier. Nothing in this Section 4.9 shall require OSUR to transfer (by license or otherwise) to a Third Party Supplier any patent or other intellectual property rights to the Product. During the period that a Supply Interruption Third Party Supplier is reasonably likely to occurmanufacturing and supplying Replacement Product under this Section 4.9, Company shall promptly notify AbbVie by telephone or by written notification and shall provide AbbVie with the opportunity to meet in person or by teleconference to discuss the details to the extent they are known by Company. 4.2.2 In the event that Company is unable, or notifies AbbVie that it is unable or otherwise receives notice from its CMO OSUR agrees that it will be unable to supplynot enforce any patent rights owned or licensed by OSUR against Distributor, for the Third Party Supplier or any reasoncustomer of Distributor in respect of the manufacture, except for a Force Majeure Eventmarketing, to supply distribution or sale of the Replacement Product in accordance with the quantities and/or delivery dates specified by AbbVie for such Product via Purchase Orders, Company shall have a period of *** days or such longer time as necessary so long as Company is using commercially reasonable efforts to cure such interruption to supply, during which time Company will prioritize AbbVie Purchase Orders of Product over Company or other customer ordersthis Agreement. If such interruption Distributor exercises its right to supply continues after such sixty (60) day period, AbbVie may, in its sole discretion: (a) cancel outstanding Purchase Orders with Company; (b) require Company to supply the undelivered Product at a future date agreed upon by the Parties; or (c) at Company’s sole expense, manufacture or have manufactured by a Third Party designated Supplier manufacture and qualified supply a Replacement Product pursuant to this Section 4.9 and thereafter during the Term OSUR desires to resume supplying Distributor with the Product (whether by AbbVie such quantity of ribavirin as AbbVie may reasonably determine with notice to Company as will meet AbbVie’s worldwide requirements in light OSUR, through another source or otherwise), then OSUR shall notify Distributor of such interruption to supplydesire. AbbVie Distributor shall be entitled to receive then resume purchasing Product exclusively from Company *** % of AbbVie’s cover damages, comprising cost differences between the Product’s cost and the replacement product’s cost, and reasonable costs associated with procuring replacements OSUR for the Productremainder of the Term of this Agreement as soon as OSUR demonstrates to Distributor’s reasonable satisfaction that OSUR (whether by OSUR, until such time as Company another source or otherwise) is capable of resuming its reestablishing a satisfactory supply obligations under this Agreementof Product. Upon Company’s resolution of the interruption to supply to the reasonable satisfaction of AbbVie, AbbVie shall be required to resume purchasing the Applicable Percentage of AbbVie Product Requirements from Company but shall be excused from purchasing Distributor agrees that portion attributable to the permitted purchases from the it will not enter into any contracts with Third Party manufacturer Suppliers in accordance with this Section 4.9 under Section 4.2.2(c)which the Distributor cannot terminate its purchase commitments for Replacement Product within ninety (90) days in order to permit the resumption of supply by OSUR in accordance herewith.

Appears in 1 contract

Samples: Distribution Agreement (Orasure Technologies Inc)

Failure to Supply. 4.2.1 If Company becomes aware that a Supply Interruption is reasonably likely to occur, Company shall promptly notify AbbVie by telephone or by written notification and shall provide AbbVie with the opportunity to meet in person or by teleconference to discuss the details to the extent they are known by Company. 4.2.2 In the event that Company is unableat any time during the term of the Agreement, or notifies AbbVie that it is unable or otherwise receives notice from its CMO that it will be unable to supplyLicensor delivers non-conforming lots of the Initial Product, for as further defined in the Technical Agreement, three (3) times in any reasontwelve (12) month period (a “Default”), except for a Force Majeure Event, to supply Product in accordance with the quantities and/or delivery dates specified by AbbVie for such Product via Purchase Orders, Company shall have a period of *** days or such longer time as necessary so long as Company is using commercially reasonable efforts to cure such interruption to supply, during which time Company will prioritize AbbVie Purchase Orders of Product over Company or other customer orders. If such interruption to supply continues after such sixty (60) day period, AbbVie may, in its sole discretion: then: (a) cancel outstanding Purchase Orders with Company; Licensee shall give written notice to Licensor specifying the occurrence of such Default (and, to the extent Licensor anticipates a possible Default, Licensor shall inform Licensee of such possibility as it becomes known to Licensor); (b) require Company The JSC shall investigate the cause of the Default. Thereafter, the Parties shall discuss in good faith through the JSC the appropriate mechanism to cure the Default based on the JSC’s investigation. Such mechanisms for cure may include for example, but without limitation, the establishment by Licensor of a secondary source for the manufacture and supply of Initial [*] = 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. Product to Licensee. In addition, where there is limited supply of conforming Licensed Product, the undelivered JSC shall determine the allocation of the available Licensed Product at a future date agreed upon by between the Parties; or Licensor Territory and the Territory, taking into consideration the sales volume of such territories in the previous 6-month period; (c) at Company’s sole expenseFollowing the Parties’ acceptance of an appropriate mechanism to cure the Default, manufacture or have manufactured by a Third Party designated and qualified by AbbVie Licensor shall use Diligent Efforts to implement such quantity of ribavirin as AbbVie may reasonably determine with notice agreed upon mechanism. In the event that Licensor fails to Company as will meet AbbVie’s worldwide requirements in light of such interruption to supply. AbbVie shall be entitled to receive from Company *** % of AbbVie’s cover damages, comprising cost differences between begin the Product’s cost and the replacement product’s cost, and reasonable costs associated with procuring replacements for the Product, until such time as Company is capable of resuming its supply obligations under this Agreement. Upon Company’s resolution implementation of the interruption agreed upon mechanism within 4 months of the Parties agreeing to supply such mechanism or fails to successfully complete the reasonable satisfaction implementation of AbbViethe agreed mechanism within 4 months of the Parties agreeing to such mechanism, AbbVie then Licensee shall be required have the right to resume purchasing execute the Applicable Percentage of AbbVie Product Requirements from Company but shall be excused from purchasing that portion attributable to the permitted purchases from the Third Party manufacturer under Manufacturing Option set forth in Section 4.2.2(c)6.18 below.

Appears in 1 contract

Samples: License and Collaboration Agreement (Tercica Inc)

Failure to Supply. 4.2.1 Atrix shall immediately notify Sanofi-Synthelabo if Atrix is unable to fill any order placed by Sanofi-Synthelabo pursuant to Section 8.07. If Company becomes aware that a Supply Interruption Atrix is reasonably likely unable to occurcure such failure within thirty (30) days after such notice, Company shall promptly notify AbbVie by telephone or by written notification and shall provide AbbVie Atrix shall, upon such failure, make arrangements with the opportunity Second Source to meet in person or Manufacture and sell to Atrix the Product until such time as Atrix is again able to Manufacture the Product; provided, however, any consequent incremental costs which result by teleconference to discuss reason of the details use of the Second Source under this Section 7.06 shall be the sole cost and liability of Atrix. Subject to the extent they are known by Company. 4.2.2 In the event that Company is unablefollowing paragraph, or notifies AbbVie that it if Atrix is unable (including due to reasons of Force Majeure) to supply Product to Sanofi-Synthelabo for a period of ninety (90) days or otherwise receives notice from its CMO more or if Atrix notifies Sanofi-Synthelabo that it Atrix will be unable to supplyperform under this Section 7.06 (or that the Second Source will be unable to perform under Section 7.05), Atrix hereby grants to Sanofi-Synthelabo a nonexclusive, royalty-free license under the Atrigel(R) Technology and any other relevant technology necessary to make or have made the Product, for any reason, except use solely for a Force Majeure Event, sale or distribution in the Territory and solely until such time as Atrix is again able to Manufacture the Product at which time Atrix will regain its exclusive right to Manufacture and supply the Product in accordance to Sanofi-Synthelabo. Sanofi-Synthelabo may grant sublicenses under the foregoing license with the quantities and/or delivery dates specified consent of Atrix, such consent not to be unreasonably withheld. At the request of Sanofi-Synthelabo, Atrix shall provide reasonable technical assistance in connection with the transfer of manufacturing described in this Section. (a) if Atrix's inability to fill any order arises as a result of [**] increase in Sanofi-Synthelabo's order over Sanofi-Synthelabo's prior forecast; or (b) in the event that Atrix must purchase additional equipment or construct a new facility in order to expand its capacity in order to meet purchase orders hereunder, Atrix will be deemed to have satisfied this paragraph by AbbVie placing a purchase order for such Product via Purchase Orders, Company shall have equipment or signing a period of *** days or contract for such longer time as necessary so long as Company is using commercially reasonable efforts to cure such interruption to supply, during which time Company will prioritize AbbVie Purchase Orders of Product over Company or other customer orders. If such interruption to supply continues after such construction within sixty (60) day period, AbbVie may, days of Atrix's receipt of Sanofi-Synthelabo's purchase order showing firm quantities in its sole discretion: (a) cancel outstanding Purchase Orders with Companyexcess of Atrix's capacity; (b) require Company to supply the undelivered Product at provided that Atrix diligently pursues and completes within a future date agreed upon by the Parties; reasonable time thereafter such purchase or (c) at Company’s sole expense, manufacture or have manufactured by a Third Party designated and qualified by AbbVie such quantity of ribavirin as AbbVie may reasonably determine with notice to Company as will meet AbbVie’s worldwide requirements in light of such interruption to supply. AbbVie shall be entitled to receive from Company *** % of AbbVie’s cover damages, comprising cost differences between the Product’s cost and the replacement product’s cost, and reasonable costs associated with procuring replacements for the Product, until such time as Company is capable of resuming its supply obligations under this Agreement. Upon Company’s resolution of the interruption to supply to the reasonable satisfaction of AbbVie, AbbVie shall be required to resume purchasing the Applicable Percentage of AbbVie Product Requirements from Company but shall be excused from purchasing that portion attributable to the permitted purchases from the Third Party manufacturer under Section 4.2.2(c)construction.

Appears in 1 contract

Samples: Collaboration, License and Supply Agreement (QLT Inc/Bc)

Failure to Supply. 4.2.1 If Company becomes aware that at any time, other than during Permitted Unavailability or a Force Majeure event, there is a failure by the Service Provider to perform or observe any one of the covenants set out in Section 5.1(a)(iii) and, in the case of Section 5.1(a)(iii)(C), such failure results in the AESO replacing all or a portion of the TMR Services (“Failure to Supply”) the AESO shall have the right to deduct from the Purchase Price for the applicable Month any payment applicable to such Failure to Supply Interruption is reasonably likely to occurin accordance with Schedule "B", Company shall promptly notify AbbVie by telephone or by written notification and shall provide AbbVie together with the opportunity to meet in person incremental cost of replacing all or by teleconference to discuss that portion of the details to TMR Services that the extent they are known by Company. 4.2.2 In the event that Company is unable, or notifies AbbVie that it is unable or otherwise receives notice from its CMO that it will be unable Service Provider failed to supply, for any reason, except for a Force Majeure Event, to supply Product in accordance with provided that the quantities and/or delivery dates specified by AbbVie AESO shall have no claim for such Product via Purchase Ordersdeduction with respect to TMR Services that have been curtailed in the entirety by the AESO (pursuant to the ISO Rules) during any portion of the hour specified in the relevant Valid Dispatch Instruction for reasons of System Security or transmission congestion management, Company shall have a period of *** days or such longer time as necessary so long as Company is using commercially reasonable efforts to cure such interruption to supply, during which time Company will prioritize AbbVie Purchase Orders of Product over Company or other customer orders. If such interruption to supply continues after such sixty (60) day period, AbbVie may, determined by the AESO in its sole discretion: (a) cancel outstanding Purchase Orders with Company; (b) require Company to supply provided, for clarity, that in the undelivered Product at a future date agreed upon by event that less than the Parties; or (c) at Company’s sole expense, manufacture or have manufactured by a Third Party designated and qualified by AbbVie such quantity entirety of ribavirin as AbbVie may reasonably determine with notice to Company as will meet AbbVie’s worldwide requirements in light of such interruption to supply. AbbVie the TMR Services are so curtailed the AESO shall be entitled to receive claim deduction from Company *** % the Service Provider for the portion of AbbVie’s cover damages, comprising cost differences between the Product’s cost TMR Services which was not actually supplied in compliance with the terms of a Valid Dispatch Instruction for the entire hour specified in such Valid Dispatch Instruction; and the replacement product’s cost, AESO may net and reasonable set-off pursuant to Section 2.3 in Schedule “B” and realize on the Financial Security in accordance with ISO Rule Section 103.7 (Financial Default and Remedies).‌ If in a Month the AESO incurs incremental costs associated with procuring replacements for the Product, until such time as Company is capable of resuming its supply obligations under this Agreement. Upon Company’s resolution replacing all or that portion of the interruption TMR Services as a result of one or more Failures to supply Supply, the AESO shall not deduct for such Month an amount of incremental costs greater than the amount of the Capacity Payment (as defined in Schedule “B”). And if the incremental costs resulting from a single Failure to Supply extend in duration to the reasonable satisfaction following Month(s), the aggregate deductions of AbbVieincremental costs related to such Failure to Supply shall not exceed an amount equal to one (1) Capacity Payment (as defined in Schedule “B”), AbbVie shall provided such Failure to Supply is determined by the AESO, acting reasonably, to be required one (1) Failure to resume purchasing the Applicable Percentage of AbbVie Product Requirements from Company but shall be excused from purchasing that portion attributable Supply and not separate or consecutive Failures to the permitted purchases from the Third Party manufacturer under Section 4.2.2(c)Supply.

Appears in 1 contract

Samples: Transmission Must Run Service Agreement

Failure to Supply. 4.2.1 If Company becomes aware that a Supply Interruption is reasonably likely (a) During the term of this Agreement, EirGenix shall continue to occur, Company shall promptly notify AbbVie by telephone or by written notification and shall provide AbbVie with manufacture the opportunity to meet Antibody at its facilities located in person or by teleconference to discuss the details to the extent they are known by Company. 4.2.2 [***]. In the event that Company is unable, EirGenix foresees or notifies AbbVie that it is unable or otherwise receives notice from its CMO becomes aware that it will be unable to supply, for deliver any reason, except for a Force Majeure Event, to supply Product shipment of the Antibody in accordance with the quantities and/or quantity and by the delivery dates date specified by AbbVie for Bolt in a purchase order (each a “Failure to Supply”), EirGenix shall promptly notify Bolt in writing. In such Product via Purchase Ordersevent, Company the Parties shall have a period of *** days or such longer time as promptly convene to identify the actions necessary so long as Company is using commercially reasonable to address the problem. EirGenix shall use its best efforts to cure such interruption promptly remedy any Failure to supply, during which time Company will prioritize AbbVie Purchase Orders Supply and resume supplying Antibody meeting the requirements of Product over Company or other customer ordersthis Agreement to Bolt as soon as possible. If such interruption All costs and expenses required to supply continues after such sixty (60) day period, AbbVie may, in its sole discretion: (a) cancel outstanding Purchase Orders with Company; remedy a Failure to Supply and incurred by EirGenix shall be borne by EirGenix. (b) require Company In the event of a Failure to Supply, EirGenix shall quickly select and establish an alternative manufacturer (which alternative manufacturer shall be reasonably acceptable to Bolt) (a “CMO”) to continue manufacturing the Antibody. EirGenix will be responsible for technology transfer costs associated with the establishment of such alternative manufacturer. The technology transfer and establishing an alternative manufacturer will be performed diligently by EirGenix but may take [***], and [***]. EirGenix will use its best efforts to continue to supply quantities of [***] to minimize the undelivered Product at impact on Bolt’s clinical development and/or commercialization until sufficient supply is available to meet Bolt’s needs. Bolt shall also have the right to terminate this Agreement in its entirety immediately upon written notice to EirGenix in the event a future date agreed Failure to Supply continues for more than [***]. In addition, Bolt shall have the right to cancel orders for any quantities of Antibody affected by such Failure to Supply effective upon by the Parties; or notice to EirGenix, and Bolt shall have no further obligations to purchase any such cancelled quantities of Antibody. (c) at Company’s sole expenseIn the event of Failure to Supply, and EirGenix does not obtain the regulatory approval from FDA for the Antibody as a standalone biosimilar product, plus if EirGenix could not establish an alternative manufacturer as set forth in Section 4.4(b), both Parties will [***], to the extent necessary or useful for Bolt to manufacture or have manufactured by a Third Party designated and qualified by AbbVie such quantity sufficient supply of ribavirin as AbbVie may reasonably determine with notice to Company as will meet AbbVie’s worldwide requirements in light of such interruption to supply. AbbVie shall be entitled to receive from Company Antibody, [*** % of AbbVie’s cover damages, comprising cost differences between the Product’s cost and the replacement product’s cost, and reasonable costs associated with procuring replacements for the Product, until such time as Company is capable of resuming its supply obligations under this Agreement. Upon Company’s resolution of the interruption to supply to the reasonable satisfaction of AbbVie, AbbVie shall be required to resume purchasing the Applicable Percentage of AbbVie Product Requirements from Company but shall be excused from purchasing that portion attributable to the permitted purchases from the Third Party manufacturer under Section 4.2.2(c)*].

Appears in 1 contract

Samples: Supply Agreement (Bolt Biotherapeutics, Inc.)

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Failure to Supply. 4.2.1 Atrix shall immediately notify Geneva if Atrix is unable or unwilling to fill any order placed by Geneva pursuant to Section 7.06 and advise Geneva of the revised delivery date. Geneva shall then have the option of terminating the purchase order without obligation of payment or of accepting the revised delivery date. If Company becomes aware (i) Atrix fails to supply for any reason Geneva's requirements of such Product as ordered by Geneva hereunder for any three (3) consecutive calendar months, then Atrix shall, upon such failure, make arrangements with a toll manufacturer, the incremental costs of which shall be borne by Atrix, to Manufacture such Product on behalf of Atrix until such time as Atrix is again able to Manufacture that Product. Notwithstanding the foregoing, Atrix shall not be deemed to be unable or unwilling to fill any order placed by Geneva as follows: (a) if Atrix's inability to fill any order arises as a Supply Interruption is reasonably likely to occur, Company shall promptly notify AbbVie by telephone or by written notification and shall provide AbbVie with the opportunity to meet result of a fifty percent (50%) increase in person or by teleconference to discuss the details to the extent they are known by Company.Geneva's order over Geneva's immediately prior forecast; or 4.2.2 In (b) in the event that Company is unableAtrix must purchase additional equipment or construct a new facility in order to expand its capacity in order to meet purchase orders hereunder, or notifies AbbVie that it is unable or otherwise receives notice from its CMO that it Atrix will be unable deemed to supply, for any reason, except for have satisfied this paragraph by placing a Force Majeure Event, to supply Product in accordance with the quantities and/or delivery dates specified by AbbVie purchase order for such Product via Purchase Orders, Company shall have equipment or signing a period of *** days or contract for such longer time as necessary so long as Company is using commercially reasonable efforts to cure such interruption to supply, during which time Company will prioritize AbbVie Purchase Orders of Product over Company or other customer orders. If such interruption to supply continues after such construction within sixty (60) day perioddays of Atrix's receipt of Geneva's purchase order showing firm quantities in excess of Atrix's capacity; provided that Atrix diligently pursues and completes within a reasonable time thereafter such purchase or construction. To reduce the possibility of unanticipated capacity shortfalls, AbbVie may, in its sole discretion: (a) cancel outstanding Purchase Orders with Company; (b) require Company to supply the undelivered Product at a future date agreed upon by the Parties; or (c) at Company’s sole expense, manufacture or have manufactured by a Third Party designated and qualified by AbbVie such quantity of ribavirin as AbbVie may reasonably determine with notice to Company as will meet AbbVie’s worldwide requirements in light of such interruption to supply. AbbVie shall be entitled to receive from Company *** % of AbbVie’s cover damages, comprising cost differences between the Product’s cost and the replacement product’s costadverse impact that would have on sales, the Parties agree to discuss, prior to the commercialization of any Product and reasonable costs associated with procuring replacements at the same time that the forecasts are delivered pursuant to Section 7.06, Atrix's available capacity for the Product, until such time as Company is capable of resuming its supply obligations under this Agreement. Upon Company’s resolution Manufacture of the interruption to supply to Products. In connection therewith, Atrix agrees that the reasonable satisfaction of AbbVie, AbbVie shall Products will be required to resume purchasing treated the Applicable Percentage of AbbVie Product Requirements from Company but shall be excused from purchasing that portion attributable to the permitted purchases from the Third Party manufacturer under Section 4.2.2(c)same as its other products when it plans its manufacturing schedule and allocates its available capacity.

Appears in 1 contract

Samples: Collaboration, Development and Supply Agreement (Atrix Laboratories Inc)

Failure to Supply. 4.2.1 If Company becomes aware that a Supply Interruption is reasonably likely to occur, Company shall promptly notify AbbVie by telephone or by written notification and shall provide AbbVie with During the opportunity to meet Term of this Agreement in person or by teleconference to discuss the details to the extent they are known by Company. 4.2.2 In the event that Company is unable, or notifies AbbVie that it is unable or otherwise receives notice from its CMO that it will be unable to supplywhich Plantex, for any reason, except for a Force Majeure Eventincluding, without limitation, force majeure as defined in Section 12 hereof, fails to supply the requisite quantities of Product for which Plantex is obligated to supply pursuant to Section 3.1.1 within [***] after the date of delivery specified by TransOral in the applicable Purchase Order (accepted and confirmed in writing by Plantex to the extent required by Section 3.3.2), then TransOral may, as its sole remedy, cover such quantities under such Purchase Order through an alternate supplier(s). Any such cover purchases shall be credited against TransOral’s purchase requirements set forth in Sections 2.1 or 2.2, as applicable. In the event Plantex regains its ability to fully resume supplying Product in accordance with the terms hereunder, TransOral’s right to cover under this Article 4 shall terminate immediately upon the delivery by Plantex to TransOral of written notice thereof. Notwithstanding anything to the contrary herein, during the Term of this Agreement in which Plantex, for any reason, including, without limitation, force majeure as defined in Section 12 hereof or pursuant to Section 7.5, fails to ship to TransOral (i) on four (4) separate occasions the requisite quantities and/or delivery of Product in a particular [***] period or (ii) [***] of the requisite quantities of Product in any [***], in each case with respect to quantities of Product for which Plantex is obligated to supply pursuant to Purchase Orders submitted by TransOral pursuant to and in accordance with the terms and conditions of this Agreement within [***] of the dates specified by AbbVie for in such Product via Purchase Orders, Company shall have a period of *** days or such longer time as necessary so long as Company is using commercially reasonable efforts to cure such interruption to supply, during which time Company will prioritize AbbVie Purchase Orders of Product over Company or other customer orders. If in compliance with this Agreement, then such interruption to supply continues after such sixty (60) day period, AbbVie may, in its sole discretion: (a) cancel outstanding Purchase Orders with Company; (b) require Company to supply the undelivered Product at a future date agreed upon by the Parties; or (c) at Company’s sole expense, manufacture or have manufactured by a Third Party designated and qualified by AbbVie such quantity of ribavirin as AbbVie may reasonably determine with notice to Company as will meet AbbVie’s worldwide requirements in light of such interruption to supply. AbbVie event shall be entitled deemed a “Supply Failure.” In the event of a Supply Failure, TransOral’s obligations to receive purchase Product from Company *** % of AbbViePlantex (including TransOral’s cover damagespurchase obligations under Sections 2.1, comprising cost differences between the Product’s cost and the replacement product’s cost2.2, 3.1, 3.2, and reasonable costs associated with procuring replacements for the Product, until such time as Company is capable of resuming its supply obligations 3.3 under this Agreement. Upon Company’s resolution of the interruption to supply to the reasonable satisfaction of AbbVie, AbbVie ) shall terminate and TransOral shall be required free to resume purchasing purchase any amount of Product from any third party for any purpose without restriction. [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Applicable Percentage of AbbVie Product Requirements from Company but shall be excused from purchasing that portion attributable to the permitted purchases from the Third Party manufacturer under Section 4.2.2(c)Securities and Exchange Commission.

Appears in 1 contract

Samples: Supply Agreement (Transcept Pharmaceuticals Inc)

Failure to Supply. 4.2.1 If Company becomes aware (A) Notwithstanding the provisions of Section 9.1 (Force Majeure Events), in the event that SNBTS shall be unable or unwilling or shall fail to supply any Product which conforms to the Product Requirements in such quantities as OCD shall request and in compliance with the delivery periods set forth in Article 6.0 (Forecasts and Ordering) (hereinafter referred to as a Supply Interruption “Failure to Supply”), then the following provisions shall apply: (1) during the initial ninety (90) days of any Failure to Supply, SNBTS shall use its best efforts to resume its supply obligations hereunder and, at its sole option, shall have the right to either: (A) designate a third-party manufacturer of the Products that is reasonably likely approved in writing by OCD (such approval not to occurbe unreasonably withheld) and license to or otherwise make available to such approved third-party manufacturer all Know How and any other technical and proprietary materials, Company shall promptly notify AbbVie by telephone intellectual property, information and techniques necessary or helpful for such third-party manufacturer to procure required raw materials, including the documents held in escrow pursuant to Section 9.3 below; or (B) by written notification notice to OCD, activate the Licenses granted pursuant to Section 9.4 of this Umbrella Agreement and make available to OCD or an alternative supplier designated by OCD and approved in writing by SNBTS (such approval not to be unreasonably withheld) all Know How and any other technical and proprietary materials, intellectual property, information and techniques necessary or helpful for OCD or its designee to procure required raw materials or to produce Products, including the documents held in escrow pursuant to Section 9.3 below. (2) if SNBTS has not resumed its supply obligations within ninety (90) days after the commencement of a Failure to Supply and: (A) OCD has not received Products by such date from an approved third-party manufacturer designated by SNBTS or has not had its Licenses activated by SNBTS by such date and (B) after consultation between SNBTS and OCD, SNBTS has failed to demonstrate to OCD’s satisfaction likely prospects of success at either ending the Failure to Supply or securing an alternative supply of Products to OCD and OCD determines in its sole discretion that it can more quickly secure such alternative supplies by acting in accordance with clause (B) of the paragraph above, then upon written notice to SNBTS by OCD the Licenses shall provide AbbVie be deemed activated and the provisions of clause (B) of the paragraph above shall apply. (B) OCD shall have no obligation to purchase Products from SNBTS for the duration of any Failure to Supply and until any contractual obligations that OCD has assumed in connection with the opportunity producing Products or obtaining them from a substitute source of supply shall have terminated. OCD shall have no obligation to meet in person or by teleconference to discuss the details affirmatively terminate any such contractual arrangement; provided, however, that OCD shall, to the extent they are known by Companythat it is commercially reasonable, make a good faith effort to limit such contractual obligations to the anticipated duration and scope of such Failure to Supply. 4.2.2 In (C) Notwithstanding anything to the contrary contained in this Umbrella Agreement, in the event that Company OCD shall make or have made the Products, pursuant to this Section 9.2, OCD shall be permitted to disclose to any third party any Confidential Information as is unablereasonably necessary in connection with such activities (subject to such third party agreeing in writing to be bound by the terms of Section 21.1 (Confidential Information) hereof). (D) Notwithstanding the foregoing provisions of this Section 9.2, if such inability, unwillingness or notifies AbbVie that it is unable or otherwise receives notice from its CMO that it will be unable to supply, for any reason, except for a Force Majeure Event, failure to supply Product in accordance Products which conform with the quantities and/or applicable Product Requirements within the delivery dates specified by AbbVie for period set forth herein occurs more than once in any calendar quarter such Product via Purchase Ordersinability, Company shall have a period of *** days unwillingness or such longer time as necessary so long as Company is using commercially reasonable efforts to cure such interruption to supply, during which time Company will prioritize AbbVie Purchase Orders of Product over Company or other customer orders. If such interruption to supply continues after such sixty (60) day period, AbbVie may, in its sole discretion: (a) cancel outstanding Purchase Orders with Company; (b) require Company to supply the undelivered Product at a future date agreed upon by the Parties; or (c) at Company’s sole expense, manufacture or have manufactured by a Third Party designated and qualified by AbbVie such quantity of ribavirin as AbbVie may reasonably determine with notice to Company as will meet AbbVie’s worldwide requirements in light of such interruption to supply. AbbVie failure shall be entitled to receive from Company *** % deemed a material breach of AbbVie’s cover damages, comprising cost differences between the Product’s cost and the replacement product’s cost, and reasonable costs associated with procuring replacements for the Product, until such time as Company is capable of resuming its supply obligations under this Umbrella Agreement. Upon Company’s resolution of the interruption to supply to the reasonable satisfaction of AbbVie, AbbVie shall be required to resume purchasing the Applicable Percentage of AbbVie Product Requirements from Company but shall be excused from purchasing that portion attributable to the permitted purchases from the Third Party manufacturer under Section 4.2.2(c).

Appears in 1 contract

Samples: Supply Umbrella Agreement (Quotient LTD)

Failure to Supply. 4.2.1 If Company becomes aware that a Innovator shall maintain sufficient capacity to manufacture Sandoz’s projected needs for Product based on each Firm Order and each Rolling Forecast during the Supply Interruption is reasonably likely to occur, Company Term. Innovator shall promptly notify AbbVie by telephone or by written notification and shall provide AbbVie with the opportunity to meet in person or by teleconference to discuss the details to the extent they are known by Company. 4.2.2 In the event that Company is unable, or notifies AbbVie Sandoz if Innovator anticipates that it is unable or otherwise receives notice from its CMO that it will shall be unable to supply, for any reason, except for deliver at least [**] percent ([**]%) of the quantity of Product ordered pursuant to the terms of this Agreement. If Innovator fails to deliver at least [**] percent ([**]%) of the quantity of Product on or before the delivery date specified in the Firm Order (other than as a result of a Force Majeure Event, any material breach of this Agreement by Sandoz or its Affiliates, or any gross negligence or willful misconduct on the part of Sandoz or its Affiliates) (a “Supply Failure”), then Sandoz may: (i) cancel some or all existing Firm Orders for Product that are subject to supply the Supply Failure without penalty; and/or (ii) recover from Innovator all actual damages, incurred and payable to third parties by Sandoz arising directly from the Supply Failure and resultant disruption (Sandoz having taken reasonable steps to mitigate such damages), including all costs and expenses reasonably incurred by Sandoz as a result thereof, including, without limitation, any amounts Sandoz pays to its customers or any other third party purchasers of Product, such as group purchasing organizations (“FTS Damages”), provided that the recovery of FTS Damages by Sandoz per Supply Failure shall be capped at the first [**] days of FTS Damages incurred and payable by Sandoz for the applicable Supply Failure. Notwithstanding anything contained herein to the contrary, upon Innovator’s provision of notice to Sandoz that it is no longer subject to a Supply Failure and is able to recommence supplying the Product to Sandoz in accordance with the quantities and/or delivery dates specified by AbbVie for such Product via Purchase Ordersthis Agreement, Company Sandoz shall have a no further rights pursuant to subsection (i) above in connection with the applicable Supply Failure, provided that Sandoz shall have the right to recover all actual damages arising from the Supply Failure that occur in the period of *** days or such longer time as necessary so long as Company is using commercially reasonable efforts to cure such interruption to supply, during which time Company will prioritize AbbVie Purchase Orders of Product over Company or other customer orders. If such interruption to supply continues after such sixty (60) day period, AbbVie may, in its sole discretion: (a) cancel outstanding Purchase Orders with Company; (b) require Company to supply the undelivered Product at a future date agreed upon by the Parties; or (c) at Companybetween Innovator’s sole expense, manufacture or have manufactured by a Third Party designated and qualified by AbbVie such quantity of ribavirin as AbbVie may reasonably determine with notice to Company as will meet AbbVie’s worldwide requirements in light provision of such interruption to supply. AbbVie shall be entitled to receive from Company *** % of AbbVie’s cover damages, comprising cost differences between the Product’s cost notice and the replacement product’s cost, and reasonable costs associated with procuring replacements for the Product, until such time as Company is capable of resuming its supply obligations under this Agreement. Upon Company’s resolution of the interruption to actual confirmed supply to the reasonable satisfaction of AbbVieSandoz by Innovator, AbbVie shall be required to resume purchasing the Applicable Percentage of AbbVie Product Requirements from Company but shall be excused from purchasing that portion attributable subject at all times to the permitted purchases from the Third Party manufacturer under Section 4.2.2(climitations set forth above in subsection (ii). The remedies set forth in subsections (i) and (ii) will be Sandoz sole remedy with respect to any Supply Failure.

Appears in 1 contract

Samples: Supply and Distribution Agreement (Medicines Co /De)

Failure to Supply. 4.2.1 If Company becomes aware that a Supply Interruption is reasonably likely to occurNotwithstanding the provisions of Section 11.01, Company shall promptly notify AbbVie by telephone or by written notification and shall provide AbbVie with the opportunity to meet in person or by teleconference to discuss the details to the extent they are known by Company. 4.2.2 In the event that Company is unable, or notifies AbbVie that it is Supplier shall be unable or otherwise receives notice from its CMO that it will be unable unwilling or shall fail to supply, for supply any reason, except for Product in such quantities as Buyer shall request and in compliance with the 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 supply as a “Failure to Supply”), then Buyer shall be permitted (after the expiration of a ***** day cure period following written notice from Buyer to supplier of such Failure to Supply and 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 accordance 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 quantities and/or delivery dates specified by AbbVie manufacturing equipment. Supplier’s obligations under this Section shall survive the termination of this Agreement for such Product via Purchase Orders, Company shall have a period of ***** days or months. Upon the occurrence of any such longer Failure to Supply and through and until such time as necessary so long as Company is using commercially reasonable efforts to cure such interruption to supply, during which time Company will prioritize AbbVie Purchase Orders of Product over Company or other customer orders. If such interruption to Supplier fully resumes its supply continues after such sixty (60) day period, AbbVie may, in its sole discretionobligations hereunder: (a) cancel outstanding Purchase Orders with CompanySupplier 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) require Company Supplier shall (at no cost to supply Supplier) make available to Buyer or its designee access to any and all Intellectual * Confidential information has been omitted and filed separately with the undelivered Product at Securities and Exchange Commission pursuant to a future date agreed upon by confidential treatment request. Property Rights (to the Partiesextent 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; or (c) Supplier shall (at Company’s sole expenseno 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 sentence once Supplier has cured the failure to supply. As soon as reasonably practicable after an uncured Failure to Supply, Supplier shall 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 a Third Party designated and qualified by AbbVie such quantity of ribavirin as AbbVie may reasonably determine with notice to Company as will meet AbbVie’s worldwide requirements in light of such interruption to supply. AbbVie shall be entitled to receive from Company *** % of AbbVie’s cover damages, comprising cost differences between the Product’s cost and the replacement product’s cost, and reasonable costs associated with procuring replacements for the Product, until such time as Company is capable of resuming its supply obligations under this Agreement. Upon Company’s resolution of the interruption to supply to the reasonable satisfaction of AbbVie, AbbVie shall be required to resume purchasing the Applicable Percentage of AbbVie Product Requirements from Company but shall be excused from purchasing that portion attributable to the permitted purchases from the Third Party manufacturer under Section 4.2.2(c).

Appears in 1 contract

Samples: Supply Agreement (Novavax Inc)

Failure to Supply. 4.2.1 If Company becomes aware that a Supply Interruption is reasonably likely to occur, Company shall promptly notify AbbVie by telephone or by written notification and shall provide AbbVie with the opportunity to meet in person or by teleconference to discuss the details to the extent they are known by Company. 4.2.2 In the event MDS cannot supply or does not deliver any MDS PRODUCT(S) (whether as a result of force majeure or otherwise) within and for the time period pursuant to the agreement between MDS and DVA’s chosen MDS CONTRACT DISTRIBUTOR, MDS agrees that Company it shall give notice as promptly as is unablepracticable under the circumstances to DVA, unless an order of a regulatory agency or other action arising out of patient safety concerns requires the giving of shorter notice. In the event MDS is unable to fulfill MDS CONTRACT DISTRIBUTOR’S contractually placed orders within the provisions of such agreement at any time during the Term of this Agreement, other than by action of the FDA, DVA’s chosen MDS CONTRACT DISTRIBUTOR shall be entitled, at a minimum, to have the same proportion of its purchase orders fulfilled at all times as other purchasers of the MDS PRODUCTS and, upon written request, MDS shall provide written assurances of same to DVA and its chosen MDS CONTRACT DISTRIBUTOR. In addition, in such circumstances, (a) any purchases of other codes of MDS bloodlines or access devices, as the case may be, or notifies AbbVie that it other manufacturers’ products by DVA shall count as MDS PRODUCT unit purchases for purposes of the BLOODLINE commitment, the AVF COMMITMENT and any MEDIC COMMITMENT and for purposes of the tier pricing and rebates for MEDIC products not subject to any MEDIC COMMITMENT set forth in Schedule B; and (b) MDS has the right to offer to DVA substitute MDS PRODUCTS at effective pricing no greater than as listed on Schedule B; and (c) if the failure to supply was not the result of force majeure [**] then MDS shall [**] and what DVA [**], but in no case shall MDS be liable for payment to DVA of such difference in excess of $[**] per pair for BLOOD TUBING PRODUCTS, $[**] per each equivalent for AVF NEEDLE SETS or $[**] per each equivalent for MEDIC. Notwithstanding the foregoing, if MDS’ failure to supply MDS PRODUCTS persists for longer than sixty (60) days and MDS is unable or otherwise receives notice from its CMO that it will be unable to supplyprovide reasonably acceptable alternative MDS PRODUCTS, for any reason, except for a Force Majeure Event, to supply Product in accordance with DVA may terminate this Agreement effective at the quantities and/or delivery dates specified by AbbVie for such Product via Purchase Orders, Company shall have a period end of *** days or such longer time as necessary so long as Company is using commercially reasonable efforts to cure such interruption to supply, during which time Company will prioritize AbbVie Purchase Orders of Product over Company or other customer orders. If such interruption to supply continues after such sixty (60) day period, AbbVie may, in its sole discretion: (a) cancel outstanding Purchase Orders with Company; (b) require Company to supply the undelivered Product at a future date agreed upon by the Parties; or (c) at Company’s sole expense, manufacture or have manufactured by a Third Party designated and qualified by AbbVie such quantity of ribavirin as AbbVie may reasonably determine with notice to Company as will meet AbbVie’s worldwide requirements in light of such interruption to supply. AbbVie shall be entitled to receive from Company *** % of AbbVie’s cover damages, comprising cost differences between the Product’s cost and the replacement product’s cost, and reasonable costs associated with procuring replacements for the Product, until such time as Company is capable of resuming its supply obligations under this Agreement. Upon Company’s resolution of the interruption to supply to the reasonable satisfaction of AbbVie, AbbVie shall be required to resume purchasing the Applicable Percentage of AbbVie Product Requirements from Company but shall be excused from purchasing that portion attributable to the permitted purchases from the Third Party manufacturer under Section 4.2.2(c).

Appears in 1 contract

Samples: Distribution Agreement (NxStage Medical, Inc.)

Failure to Supply. 4.2.1 If Company becomes aware that a Supply Interruption is reasonably likely to occurELITE shall notify LXXXXXX as promptly as possible, Company shall promptly notify AbbVie by telephone or by written notification and shall provide AbbVie with the opportunity to meet but in person or by teleconference to discuss the details to the extent they are known by Company. 4.2.2 In the no event that Company is unablelater than five (5) Business Days, or notifies AbbVie that it is unable or otherwise receives notice from its CMO after ELITE discovers that it will not be unable able to supply the quantity of Products ordered by the delivery date specified in a Purchase Order. In such event: (i) ELITE shall cooperate with LXXXXXX in taking all actions that LXXXXXX xxxxx reasonably necessary in order to remedy such inability to supply, for any reason, except for a Force Majeure Event, at ELITE’s expense; and (ii) If ELITE’s inability to supply Product continues past twenty (20) days from the required delivery date set forth in accordance with the quantities and/or delivery dates specified by AbbVie for Purchase Order at LANNETT’s election, any or all outstanding Purchase Orders relating to such Product via may be cancelled and LANNETT shall have no obligations with respect to such Purchase Orders; provided, Company however, ELITE must cover any Failure to Supply (as defined below) obligations set forth in this Section. Compliance by ELITE with this Article 4.4 shall have not relieve ELITE of any other obligation or liability under this Agreement. LANNETT shall otherwise retain all of its rights under this Agreement and/or at law against ELITE for its failure to deliver all or any portion of the quantity of Products ordered by LXXXXXX. With regards to a period Binding Forecast or if ELITE accepted a Purchase Order from LANNETT, pursuant to the procedures defined in Section 4.2 of *** days this Agreement, then ELITE shall be responsible for the late charges and any penalties assessed against LANNETT by its Customers or such longer time as necessary so long as Company any other third party or any costs, fees, charges, or penalties incurred by Lxxxxxx (“Failure to Supply”), unless the delay is using attributable to (i) action or controls imposed by the DEA that do not result from ELITE’s negligence, gross negligence or willful misconduct; or (ii) demonstrable raw material shortages that are beyond ELITE’s control, but ELITE will use commercially reasonable efforts to cure such interruption keep three (3) to supply, during which time Company will prioritize AbbVie Purchase Orders six (6) months of Product over Company or other customer ordersraw materials inventory on hand at all times. If such interruption to supply continues after such sixty (60) day period, AbbVie may, in its sole discretion: (a) cancel outstanding Purchase Orders with Company; (b) require Company to supply the undelivered Product at a future date agreed upon Late charges and any penalties assessed against ELITE by the Parties; or (c) at Company’s sole expense, manufacture or have manufactured by a Third Party designated and qualified by AbbVie such quantity of ribavirin as AbbVie may reasonably determine with notice to Company as will meet AbbVie’s worldwide requirements in light of such interruption to supply. AbbVie shall be entitled to receive from Company *** % of AbbVie’s cover damages, comprising cost differences between the Product’s cost and the replacement product’s cost, and reasonable costs associated with procuring replacements for the Product, until such time as Company is capable of resuming its supply obligations LXXXXXX under this Agreement. Upon Company’s resolution paragraph are due and payable within thirty (30) days of the interruption being invoiced by LXXXXXX and, if not timely paid, may be deducted against amounts owed by LXXXXXX to supply to the reasonable satisfaction of AbbVie, AbbVie shall be required to resume purchasing the Applicable Percentage of AbbVie Product Requirements from Company but shall be excused from purchasing that portion attributable to the permitted purchases from the Third Party manufacturer under Section 4.2.2(c)ELITE.

Appears in 1 contract

Samples: License, Supply and Distribution Agreement (Elite Pharmaceuticals Inc /Nv/)

Failure to Supply. 4.2.1 If Company becomes aware that a Supply Interruption is reasonably likely (a) During the term of this Agreement, EirGenix shall continue to occur, Company shall promptly notify AbbVie by telephone or by written notification and shall provide AbbVie with manufacture the opportunity to meet Antibody at its facilities located in person or by teleconference to discuss the details to the extent they are known by Company. 4.2.2 [***]. In the event that Company is unable, EirGenix foresees or notifies AbbVie that it is unable or otherwise receives notice from its CMO becomes aware that it will be unable to supply, for deliver any reason, except for a Force Majeure Event, to supply Product shipment of the Antibody in accordance with the quantities and/or quantity and by the delivery dates date specified by AbbVie for Bolt in a purchase order (each a “Failure to Supply”), EirGenix shall promptly notify Bolt in writing. In such Product via Purchase Ordersevent, Company the Parties shall have a period of *** days or such longer time as promptly convene to identify the actions necessary so long as Company is using commercially reasonable to address the problem. EirGenix shall use its best efforts to cure such interruption promptly remedy any Failure to supply, during which time Company will prioritize AbbVie Purchase Orders Supply and resume supplying Antibody meeting the requirements of Product over Company or other customer ordersthis Agreement to Bolt as soon as possible. If such interruption All costs and expenses required to supply continues after such sixty (60) day period, AbbVie may, in its sole discretion: (a) cancel outstanding Purchase Orders with Company; remedy a Failure to Supply and incurred by EirGenix shall be borne by EirGenix. (b) require Company In the event of a Failure to Supply, EirGenix shall quickly select and establish an alternative manufacturer (which alternative manufacturer shall be reasonably acceptable to Bolt) (a “CMO”) to continue manufacturing the Antibody. EirGenix will be responsible for technology transfer costs associated with the establishment of such alternative manufacturer. The technology transfer and establishing an alternative manufacturer will be performed diligently by EirGenix but may take [***], and [***]. EirGenix will use its best efforts to continue to supply quantities of EG12014 to minimize the undelivered Product at impact on Bolt’s clinical development and/or commercialization until sufficient supply is available to meet Bolt’s needs. Bolt shall also have the right to terminate this Agreement in its entirety immediately upon written notice to EirGenix in the event a future date agreed Failure to Supply continues for more than [***]. In addition, Bolt shall have the right to cancel orders for any quantities of Antibody affected by such Failure to Supply effective upon by notice to EirGenix, and if so cancelled, EirGenix shall refund any payments already made for the Parties; or affected order(s) and Bolt shall have no further obligations to purchase any such cancelled quantities of Antibody. (c) at Company’s sole expenseIn the event of Failure to Supply, and EirGenix does not obtain the regulatory approval from FDA for the Antibody as a standalone biosimilar product, plus if EirGenix could not establish an alternative manufacturer as set forth in Section (b), both Parties will [***], to the extent necessary or useful for Bolt to manufacture or have manufactured by a Third Party designated and qualified by AbbVie such quantity sufficient supply of ribavirin as AbbVie may reasonably determine with notice to Company as will meet AbbVie’s worldwide requirements in light of such interruption to supply. AbbVie shall be entitled to receive from Company Antibody, [*** % of AbbVie’s cover damages, comprising cost differences between the Product’s cost and the replacement product’s cost, and reasonable costs associated with procuring replacements for the Product, until such time as Company is capable of resuming its supply obligations under this Agreement. Upon Company’s resolution of the interruption to supply to the reasonable satisfaction of AbbVie, AbbVie shall be required to resume purchasing the Applicable Percentage of AbbVie Product Requirements from Company but shall be excused from purchasing that portion attributable to the permitted purchases from the Third Party manufacturer under Section 4.2.2(c)*].

Appears in 1 contract

Samples: Supply Agreement (Bolt Biotherapeutics, Inc.)

Failure to Supply. 4.2.1 If Company becomes aware that a Supply Interruption is reasonably likely to occurELITE shall notify LANNETT as promptly as possible, Company shall promptly notify AbbVie by telephone or by written notification and shall provide AbbVie with the opportunity to meet but in person or by teleconference to discuss the details to the extent they are known by Company. 4.2.2 In the no event that Company is unablelater than five (5) Business Days, or notifies AbbVie that it is unable or otherwise receives notice from its CMO after ELITE discovers that it will not be unable able to supply the quantity of Products ordered by the delivery date specified in a Purchase Order. In such event: (i) ELITE shall cooperate with LANNETT in taking all actions that XXXXXXX xxxxx reasonably necessary in order to remedy such inability to supply, for any reason, except for a Force Majeure Event, at ELITE’s expense; and (ii) If ELITE’s inability to supply Product continues past twenty (20) days from the required delivery date set forth in accordance with the quantities and/or delivery dates specified by AbbVie for Purchase Order at LANNETT’s election, any or all outstanding Purchase Orders relating to such Product via may be cancelled and LANNETT shall have no obligations with respect to such Purchase Orders; provided, Company however, ELITE must cover any Failure to Supply (as defined below) obligations set forth in this Section. Compliance by ELITE with this Article 4.4 shall have not relieve ELITE of any other obligation or liability under this Agreement. LANNETT shall otherwise retain all of its rights under this Agreement and/or at law against ELITE for its failure to deliver all or any portion of the quantity of Products ordered by LANNETT. With regards to a period Binding Forecast or if ELITE accepted a Purchase Order from LANNETT, pursuant to the procedures defined in Section 4.2 of *** days this Agreement, then ELITE shall be responsible for the late charges and any penalties assessed against LANNETT by its Customers or such longer time as necessary so long as Company any other third party or any costs, fees, charges, or penalties incurred by Lannett (“Failure to Supply”), unless the delay is using attributable to (i) action or controls imposed by the DEA that do not result from ELITE’s negligence, gross negligence or willful misconduct; or (ii) demonstrable raw material shortages that are beyond ELITE’s control, but ELITE will use commercially reasonable efforts to cure such interruption keep three (3) to supply, during which time Company will prioritize AbbVie Purchase Orders six (6) months of Product over Company or other customer ordersraw materials inventory on hand at all times. If such interruption to supply continues after such sixty (60) day period, AbbVie may, in its sole discretion: (a) cancel outstanding Purchase Orders with Company; (b) require Company to supply the undelivered Product at a future date agreed upon Late charges and any penalties assessed against ELITE by the Parties; or (c) at Company’s sole expense, manufacture or have manufactured by a Third Party designated and qualified by AbbVie such quantity of ribavirin as AbbVie may reasonably determine with notice to Company as will meet AbbVie’s worldwide requirements in light of such interruption to supply. AbbVie shall be entitled to receive from Company *** % of AbbVie’s cover damages, comprising cost differences between the Product’s cost and the replacement product’s cost, and reasonable costs associated with procuring replacements for the Product, until such time as Company is capable of resuming its supply obligations LANNETT under this Agreement. Upon Company’s resolution paragraph are due and payable within thirty (30) days of the interruption being invoiced by LANNETT and, if not timely paid, may be deducted against amounts owed by LANNETT to supply to the reasonable satisfaction of AbbVie, AbbVie shall be required to resume purchasing the Applicable Percentage of AbbVie Product Requirements from Company but shall be excused from purchasing that portion attributable to the permitted purchases from the Third Party manufacturer under Section 4.2.2(c)ELITE.

Appears in 1 contract

Samples: License, Supply and Distribution Agreement (Elite Pharmaceuticals Inc /Nv/)

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