Common use of Supply Continuity Clause in Contracts

Supply Continuity. (a) In the event Blu determines that it will not be able to supply Journey Products to Journey in material satisfaction of the most recent orders and/or Forecasts, Blu shall promptly notify Journey in writing of such determination, which notice shall provide Journey with the details on the extent of the expected shortfall of supply, the causes of such inability to supply, and Blu's proposed solution to the problem. (b) In the event Journey reasonably believes that Blu will be unable to meet Journey's forecasts for a Journey Product for more than thirty (30) days (a "Supply Interruption"), then Journey shall have the right, upon thirty (30) days written notice to Blu ("Manufacturing Notice"), to manufacture or have manufactured by a Backup Manufacturer (as defined below) the Journey Products unless Journey has, during such thirty (30) day period (the "Assurance Period"), received reasonable evidence of Blu's ability to meet such forecasts and reasonably determined that Blu will be able to meet such forecasts ("Supply Continuity Assurance Confirmation"). Without limiting the generality of the foregoing, a Supply Interruption shall be deemed to occur if: (i) Blu, with respect to any order of Journey Product, fails to supply, on a timely basis, at least 90% of Journey Product under such order conforming to the Journey Product Requirements; (ii) a Force Majeure Event affecting the performance of Blu specified in Article 8 shall continue for more than sixty (60) days; or (iii) any facility involved in manufacturing-related activities regarding the Journey Product (including, without limitation, packaging, labeling, testing, storing and release) is prohibited from, or materially adversely affected in its ability to, produce, store, or otherwise be in involved in the Manufacture or provision of such Journey Product to Journey under this. Supply Agreement by Regulatory Authorities or due to a failure to comply with Applicable Laws or cGMP. (c) Notwithstanding anything to the contrary herein, Journey shall at any time during the Term be entitled to qualify itself, its Affiliates and/or one or more Third Parties ("Backup Manufacturers"), to manufacture Journey Products for the purpose of such Backup Manufacturers supplying Journey with Journey Product upon a Supply Interruption. Blu acknowledges that the manufacture of Journey Product by a Backup Manufacturer shall not be a violation of this Agreement or any rights of Blu or its Affiliates. (d) Subject to Blu's right to reject a Backup Manufacturer as described below, upon Journey's written request at any time (the "Backup Manufacturer Request"), Blu shall promptly (i) file (within thirty (30) days of Blu's receipt from Journey of all information reasonably necessary to file) with the FDA a supplement to the Blu ANDA and any other documents necessary to designate, qualify, authorize and obtain FDA approval of, Backup Manufacturers identified by Journey in the Backup Manufacturer Request to manufacture Journey Product and (ii) take any other actions reasonably requested by Journey to (x) accomplish such designation, qualification, authorization or approval and (y) obtain approvals necessary for Blu to manufacture or have manufactured Journey Product. Blu shall not take any action that would result in the termination of, or otherwise adversely affect, such designation and authorization. Journey shall reimburse Blu for its reasonable, documented out-of-pocket third party costs incurred in performing its obligations under this Section 4.11(d). If Blu, within seven (7) days of a receipt of a Backup Manufacturer Request, reasonably determines that a Backup Manufacturer identified therein (i) will not be able to manufacture Product in compliance with the Product Requirements, (ii) is at such time a manufacturer of doxycycline or a product which directly competes with Doxycycline, or (iii) reasonably unsuitable from a compliance or risk standpoint, then it may reject such Backup Manufacturer by providing to Journey written notice of the same during such seven (7) day period, which notice shall include reasonably detailed reasons for such rejection. INFORMATION HAS BEEN MARKED WITH “[***]. (e) Within thirty (30) days of the Effective Date, Blu shall deliver to Journey (and/or any Backup Manufacturer designated thereby), copies of the Data Package and any other information, including technical information, that is owned or controlled by, or in the possession of, Blu or any Affiliate thereof, that is reasonably necessary or useful to permit a Backup Manufacturer to manufacture Journey Product, including but not limited to information regarding acquiring raw materials from Blu's sources of such raw materials (the "Transferred Know-How"). Blu shall promptly provide any other information requested by Journey from time to time during the Term that is reasonably necessary or useful to permit a Backup Manufacturer to manufacture Journey Product. Blu shall provide Journey or any Third Party designee thereof reasonable assistance, at Journey's request, with respect to understanding and implementing such Transferred Know-How. (f) Blu hereby grants Journey a license, until the expiration of the then-current Term to and under all Product Intellectual Property Rights, Transferred Know-How and the Blu ANDA (including a right to reference the Blu ANDA) to (i) use, make and have made Journey Products worldwide for Qualification Purposes-and (ii) sell, offer for sale and import such Journey Products in the Territory. "Qualification Purposes" means (x) qualifying as a manufacturer of Journey Products and (y) maintaining qualification as a manufacturer of Journey Products.

Supply Continuity. (a) In the event Blu determines case Celltrion is unable to, or reasonably believes that it will not be able to, supply Rani’s requirements of Drug Product and/or Drug Substance under this Agreement, Celltrion will promptly notify Rani of any actual or potential disruption to its ability to supply Journey Products Drug Product and/or Drug Substance to Journey Rani in material satisfaction of the most recent orders and/or Forecasts, Blu shall promptly notify Journey full in writing of such determination, which notice shall provide Journey accordance with the details on the extent terms of the expected shortfall of supplythis Agreement (a “Supply Disruption”). In such event, the causes of Parties will promptly meet to discuss such inability situation and to supply, and Blu's proposed solution seek a mutually agreeable mitigation or resolution to the problem. Supply Disruption (b) In the event Journey reasonably believes that Blu will be unable which could include, without limitation, build-up of inventory, or other solutions). During any Supply Disruption, Rani, subject to meet Journey's forecasts for a Journey Product for more than thirty (30) days (a "Supply Interruption"), then Journey shall have the right, upon thirty (30) days [*] days’ prior written notice to Blu Celltrion, will have the right to obtain supply of Drug Product and/or Drug Substance or other adalimumab biosimilar for use in Product from Third Parties ("Manufacturing Notice"), “Alternate Supply”) as it determines to manufacture be reasonably necessary or have manufactured by a Backup Manufacturer (as defined below) the Journey Products unless Journey has, during such thirty (30) day period (the "Assurance Period"), received reasonable evidence of Blu's ability appropriate to meet such forecasts and reasonably determined that Blu will be able to meet such forecasts ("Supply Continuity Assurance Confirmation"). Without limiting the generality of the foregoing, avoid or remedy a Supply Interruption shall be deemed to occur if: (i) Blu, with respect to any order of Journey Product, fails to supply, on a timely basis, at least 90% of Journey Product under such order conforming to the Journey Product Requirements; (ii) a Force Majeure Event affecting the performance of Blu specified in Article 8 shall continue for more than sixty (60) days; or (iii) any facility involved in manufacturing-related activities regarding the Journey Product Disruption (including, without limitation, packaging, labeling, testing, storing and releasesuch period(s) is prohibited from, or materially adversely affected quantities of supply to which Rani has to reasonably commit in its ability to, produce, store, or otherwise be in involved in the Manufacture or provision of order to obtain supply from such Journey Product to Journey under this. Supply Agreement by Regulatory Authorities or due to a failure to comply with Applicable Laws or cGMP. (c) Notwithstanding anything to the contrary herein, Journey shall at any time during the Term be entitled to qualify itself, its Affiliates and/or one or more Third Parties ("Backup Manufacturers"), to manufacture Journey Products for the purpose of such Backup Manufacturers supplying Journey with Journey Product upon a Supply Interruption. Blu acknowledges that the manufacture of Journey Product by a Backup Manufacturer shall not be a violation of this Agreement or any rights of Blu or its Affiliates. (d) Subject to Blu's right to reject a Backup Manufacturer as described below, upon Journey's written request at any time (the "Backup Manufacturer Request"), Blu shall promptly (i) file (within thirty (30) days of Blu's receipt from Journey of all information reasonably necessary to file) with the FDA a supplement to the Blu ANDA and any other documents necessary to designate, qualify, authorize and obtain FDA approval of, Backup Manufacturers identified by Journey in the Backup Manufacturer Request to manufacture Journey Product and (ii) take any other actions reasonably requested by Journey to (x) accomplish such designation, qualification, authorization or approval and (y) obtain approvals necessary for Blu to manufacture or have manufactured Journey Product. Blu shall not take any action that would result in the termination of, or otherwise adversely affect, such designation and authorization. Journey shall reimburse Blu for its reasonable, documented out-of-pocket third party costs incurred in performing its obligations under this Section 4.11(d). If Blu, within seven (7) days of a receipt of a Backup Manufacturer Request, reasonably determines that a Backup Manufacturer identified therein (i) will not be able to manufacture Product in compliance with the Product Requirements, (ii) is at such time a manufacturer of doxycycline or a product which directly competes with Doxycycline, or (iii) reasonably unsuitable from a compliance or risk standpoint, then it may reject such Backup Manufacturer by providing to Journey written notice of the same during such seven (7) day period, which notice shall include reasonably detailed reasons for such rejection. INFORMATION HAS BEEN MARKED WITH “[***]. (e) Within thirty (30) days of the Effective Date, Blu shall deliver to Journey (and/or any Backup Manufacturer designated thereby), copies of the Data Package and any other information, including technical information, that is owned or controlled by, or in the possession of, Blu or any Affiliate thereof, that is reasonably necessary or useful to permit a Backup Manufacturer to manufacture Journey Product, including but not limited to information regarding acquiring raw materials from Blu's sources of such raw materials (the "Transferred Know-How"). Blu shall promptly provide any other information requested by Journey from time to time during the Term that is reasonably necessary or useful to permit a Backup Manufacturer to manufacture Journey Product. Blu shall provide Journey or any Third Party designee thereof reasonable assistance, at Journey's request, with respect to understanding and implementing such Transferred Know-How. (f) Blu hereby grants Journey a licenseSupply Disruption). If, until the expiration as of the then-current Term time Celltrion has remedied a Supply Disruption (and no further Supply Disruption is foreseeable), Rani will use reasonable efforts to transition back to use of Celltrion supply of DP and/or DS hereunder if and under all when reasonably practicable, provided that it would not unduly interfere with Xxxx’s continued development, manufacture or commercialization of Product Intellectual Property Rights, Transferred Know-How as determined by Rani in its reasonable judgment. Celltrion will reimburse Rani for the difference between the costs of obtaining Alternate Supply and the Blu ANDA cost of obtaining such supply from Celltrion, as well as costs associated with mitigation activities with respect to a Supply Disruption hereunder (including a right and Rani may offset such costs against any amounts owed to reference the Blu ANDA) Celltrion hereunder), in addition to (i) use, make and have made Journey Products worldwide for Qualification Purposes-and (ii) sell, offer for sale and import such Journey Products any other remedies available at law or in the Territory. "Qualification Purposes" means (x) qualifying as a manufacturer of Journey Products and (y) maintaining qualification as a manufacturer of Journey Productsequity.

Supply Continuity. (a) In the event Blu determines case Celltrion is unable to, or reasonably believes that it will not be able to, supply Rani’s requirements of Drug Product and/or Drug Substance under this Agreement, Celltrion will promptly notify Rani of any actual or potential disruption to its ability to supply Journey Products Drug Product and/or Drug Substance to Journey Rani in material satisfaction of the most recent orders and/or Forecasts, Blu shall promptly notify Journey full in writing of such determination, which notice shall provide Journey accordance with the details on the extent terms of the expected shortfall of supplythis Agreement (a “Supply Disruption”). In such event, the causes of Parties will promptly meet to discuss such inability situation and to supply, and Blu's proposed solution seek a mutually agreeable mitigation or resolution to the problem. Supply Disruption (b) In the event Journey reasonably believes that Blu will be unable which could include, without limitation, build-up of inventory, or other solutions). During any Supply Disruption, Rani, subject to meet Journey's forecasts for a Journey Product for more than thirty (30) days (a "Supply Interruption"), then Journey shall have the right, upon thirty (30) days [*] days’ prior written notice to Blu Celltrion, will have the right to obtain supply of Drug Product and/or Drug Substance or other ustekinumab biosimilar for use in Product from Third Parties ("Manufacturing Notice"), “Alternate Supply”) as it determines to manufacture be reasonably necessary or have manufactured by a Backup Manufacturer (as defined below) the Journey Products unless Journey has, during such thirty (30) day period (the "Assurance Period"), received reasonable evidence of Blu's ability appropriate to meet such forecasts and reasonably determined that Blu will be able to meet such forecasts ("Supply Continuity Assurance Confirmation"). Without limiting the generality of the foregoing, avoid or remedy a Supply Interruption shall be deemed to occur if: (i) Blu, with respect to any order of Journey Product, fails to supply, on a timely basis, at least 90% of Journey Product under such order conforming to the Journey Product Requirements; (ii) a Force Majeure Event affecting the performance of Blu specified in Article 8 shall continue for more than sixty (60) days; or (iii) any facility involved in manufacturing-related activities regarding the Journey Product Disruption (including, without limitation, packaging, labeling, testing, storing and releasesuch period(s) is prohibited from, or materially adversely affected quantities of supply to which Rani has to reasonably commit in its ability to, produce, store, or otherwise be in involved in the Manufacture or provision of order to obtain supply from such Journey Product to Journey under this. Supply Agreement by Regulatory Authorities or due to a failure to comply with Applicable Laws or cGMP. (c) Notwithstanding anything to the contrary herein, Journey shall at any time during the Term be entitled to qualify itself, its Affiliates and/or one or more Third Parties ("Backup Manufacturers"), to manufacture Journey Products for the purpose of such Backup Manufacturers supplying Journey with Journey Product upon a Supply Interruption. Blu acknowledges that the manufacture of Journey Product by a Backup Manufacturer shall not be a violation of this Agreement or any rights of Blu or its Affiliates. (d) Subject to Blu's right to reject a Backup Manufacturer as described below, upon Journey's written request at any time (the "Backup Manufacturer Request"), Blu shall promptly (i) file (within thirty (30) days of Blu's receipt from Journey of all information reasonably necessary to file) with the FDA a supplement to the Blu ANDA and any other documents necessary to designate, qualify, authorize and obtain FDA approval of, Backup Manufacturers identified by Journey in the Backup Manufacturer Request to manufacture Journey Product and (ii) take any other actions reasonably requested by Journey to (x) accomplish such designation, qualification, authorization or approval and (y) obtain approvals necessary for Blu to manufacture or have manufactured Journey Product. Blu shall not take any action that would result in the termination of, or otherwise adversely affect, such designation and authorization. Journey shall reimburse Blu for its reasonable, documented out-of-pocket third party costs incurred in performing its obligations under this Section 4.11(d). If Blu, within seven (7) days of a receipt of a Backup Manufacturer Request, reasonably determines that a Backup Manufacturer identified therein (i) will not be able to manufacture Product in compliance with the Product Requirements, (ii) is at such time a manufacturer of doxycycline or a product which directly competes with Doxycycline, or (iii) reasonably unsuitable from a compliance or risk standpoint, then it may reject such Backup Manufacturer by providing to Journey written notice of the same during such seven (7) day period, which notice shall include reasonably detailed reasons for such rejection. INFORMATION HAS BEEN MARKED WITH “[***]. (e) Within thirty (30) days of the Effective Date, Blu shall deliver to Journey (and/or any Backup Manufacturer designated thereby), copies of the Data Package and any other information, including technical information, that is owned or controlled by, or in the possession of, Blu or any Affiliate thereof, that is reasonably necessary or useful to permit a Backup Manufacturer to manufacture Journey Product, including but not limited to information regarding acquiring raw materials from Blu's sources of such raw materials (the "Transferred Know-How"). Blu shall promptly provide any other information requested by Journey from time to time during the Term that is reasonably necessary or useful to permit a Backup Manufacturer to manufacture Journey Product. Blu shall provide Journey or any Third Party designee thereof reasonable assistance, at Journey's request, with respect to understanding and implementing such Transferred Know-How. (f) Blu hereby grants Journey a licenseSupply Disruption). If, until the expiration as of the then-current Term time Celltrion has remedied a Supply Disruption (and no further Supply Disruption is foreseeable), Rani will use reasonable efforts to transition back to use of Celltrion supply of DP and/or DS hereunder if and under all when reasonably practicable, provided that it would not unduly interfere with Xxxx’s continued development, manufacture or commercialization of Product Intellectual Property Rights, Transferred Know-How as determined by Rani in its reasonable judgment. Celltrion will reimburse Rani for the difference between the costs of obtaining Alternate Supply and the Blu ANDA cost of obtaining such supply from Celltrion, as well as costs associated with mitigation activities with respect to a Supply Disruption hereunder (including a right and Rani may offset such costs against any amounts owed to reference the Blu ANDA) Celltrion hereunder), in addition to (i) use, make and have made Journey Products worldwide for Qualification Purposes-and (ii) sell, offer for sale and import such Journey Products any other remedies available at law or in the Territory. "Qualification Purposes" means (x) qualifying as a manufacturer of Journey Products and (y) maintaining qualification as a manufacturer of Journey Productsequity.