Obligations on Termination. (a) If a Product Agreement is completed, expires, is terminated by Patheon in accordance with Section 8.2(a), (b) or (e), or is terminated by Client in accordance with Section 8.2(c), 8.2(d) or 8.2(f), in whole or in part for any reason, then: (i) Client will take delivery of and pay for all undelivered Products that are manufactured and/or packaged in accordance with this Agreement under a Firm Order, at the Price in effect at the time the Firm Order was placed; (ii) Client will purchase, at Patheon's cost (including all third party costs incurred by Patheon for the purchase and handling of the Inventory), the Inventory applicable to the Products which was purchased, maintained or produced by Patheon in contemplation of filling Firm Orders or in accordance with Section 5.2; (iii) Client will satisfy the purchase price payable under Patheon's orders with suppliers of Components, if the orders were made by Patheon in reliance on Firm Orders or in accordance with Section 5.2; (iv) Client acknowledges that no Patheon Competitor will be permitted access to the Manufacturing Site; and (v) Client will make commercially reasonable efforts, at its own expense, to remove from Patheon site(s), within [***] days, all unused Active Material and Client-Supplied Components, all applicable Inventory and Materials (whether current or obsolete), supplies, undelivered Product, chattels, equipment or other moveable property owned by Client, related to the Agreement and located at a Patheon site or that is otherwise under Patheon’s care and control (“Client Property”). If Client fails to remove Client Property within [***] days following the completion, termination, or expiration of the Product Agreement, Client will pay Patheon [***] for storing Client Property and will assume any third party storage charges invoiced to Patheon regarding Client Property. Patheon will invoice Client for the storage charges as set forth in Section 5.5 of this Agreement. If Client asks Patheon to destroy any Client Property, Client will be responsible for the cost of destruction. (b) If a Product Agreement is terminated by Client in accordance with Section 8.2(a) because Patheon has delivered Product that does not conform to the Specifications, cGMPs or Applicable Laws, then (i) Section 8.3(a)(i) shall apply but only to the extent that the Product conforms to the Specifications, cGMPs or Applicable Laws, (ii) Section 8.3(a)(iv) shall apply, and (iii) Section 8.4(a)(v) shall apply but only with respect to all Client Property other than Inventory and Materials (but including Client-Supplied Components). (c) Any completion, termination or expiration of this Agreement or a Product Agreement will not affect any outstanding obligations or payments due prior to the completion, termination or expiration, nor will it prejudice any other remedies that the parties may have under this Agreement or a Product Agreement or any related Capital Equipment Agreement. For greater certainty, completion, termination or expiration of this Agreement or of a Product Agreement for any reason will not affect the obligations and responsibilities of the parties under Articles 6, 10, 11 and 13 and Sections 2.2, 5.4, 5.5, 7.3 and 7.7 and this Section 8.4 and any other provisions of this Agreement which by their terms are expressed to survive any completion, termination or expiration, all of which survive any completion, termination or expiration.
Appears in 2 contracts
Samples: Master Manufacturing Services Agreement, Master Manufacturing Services Agreement (Recro Pharma, Inc.)
Obligations on Termination. (a) If a Product Agreement is completed, expires, is terminated by Patheon in accordance with Section 8.2(a), (b) or (e), or is terminated by Client in accordance with Section 8.2(c), 8.2(d) or 8.2(f), in whole or in part for any reason, then:
(ia) Client will take delivery of and pay for all undelivered Products that are manufactured and/or packaged in accordance with this Agreement under a Firm Order, at the Price price in effect at the time the Firm Order was placed;
(iib) Client will purchase, at Patheon's cost (including all third party costs incurred by Patheon for the purchase and plus [***] handling of the Inventory)fee, the Inventory applicable to the Products which was purchased, produced or maintained or produced by Patheon in contemplation of filling Firm Orders or in accordance with Section 5.25.2 prior to notice of termination being given; provided that Patheon will make commercially reasonable efforts to mitigate any costs payable by Client in connection therewith, which may include canceling any pending orders for such Components, returning or selling items in the Inventory back to its supplier(s) if possible, or otherwise utilizing such Inventory or Components with other Patheon clients or otherwise in Patheon’s business;
(iiic) Client will satisfy the purchase price payable under Patheon's orders with suppliers of Components, if the orders were made by Patheon in reliance on Firm Orders or in accordance with Section 5.2, and thereafter Client will have sole right, title and interest in and to such Components;
(ivd) Client acknowledges that no Patheon Competitor will be permitted access to the Manufacturing Site; and;
(ve) Client will make commercially reasonable efforts, at its own expense, to remove from Patheon site(s), within [***] days], all unused Active Material and Client-Supplied Components, all applicable Inventory and Materials (whether current or obsolete), supplies, undelivered Product, chattels, equipment or other moveable property owned by Client, related to the Agreement and located at a Patheon site or that is otherwise under Patheon’s care and control (“Client Property”). If Client fails to remove the Client Property within [***] days following the completion, termination, or expiration of the Product Agreement, Client will pay Patheon [***] per pallet, per month, one pallet minimum (except, if applicable, Client will pay [***] per pallet, per month, one pallet minimum, for any of the Client Property that contains controlled substances, requires refrigeration or other special storage requirements) thereafter for storing the Client Property and will assume any third party storage charges invoiced to Patheon regarding the Client Property; provided that no such charges shall be applicable and payable by Client if Client notifies Patheon to destroy/dispose of such Client Property. Patheon will invoice Client for the storage charges as set forth in Section 5.5 of this Agreement. If ;
(f) Pursuant to a reasonable written request from Client asks to Patheon, Patheon shall transfer to destroy Client and/or its designee any and all Client Intellectual Property in Patheon’s possession and shall provide to Client and/or its designee Patheon Intellectual Property, so as to permit Client will be responsible for the cost of destruction.
(band/or its designee(s) If a Product Agreement is terminated by Client to produce/manufacture Products with such technical assistance being provided in accordance with Section 8.2(aa plan provided to Patheon by Client. To the extent transferable, Patheon shall also transfer any license(s) because obtained specifically for the production/manufacture of Products under this Agreement. Patheon has delivered Product hereby grants to Client [***] any and all Patheon Intellectual Property to make, have made, use, offer for sale, sell, and import Products, which license shall survive termination of this Agreement. However, no Competitor of Patheon in the business of contract development or manufacture of drug products will be permitted to have access to Patheon’s manufacturing site. The third party manufacturer will be required to sign a customary and appropriate confidentiality agreement with Patheon concerning the nondisclosure of Patheon confidential information that does not conform may be involved in the transfer;
(g) Except to the Specificationsextent necessary to complete performance pursuant to subsection (f) or to exercise rights that survive the termination of this Agreement, cGMPs each party as a receiving party shall deliver to the disclosing party such disclosing party’s Confidential Information in the receiving party’s possession or Applicable Lawscontrol. Notwithstanding anything in this Agreement that may be to the contrary, then Client (and its designees) may continue to retain and use Patheon Confidential Information that is required to maintain marketing approval for a Product and/or is useful to production/manufacture of the Product;
(h) Promptly following any notice of termination of expiration, Patheon will update and confirm the technical information and specifications for the Product as set forth in the Specifications (Schedule A), Stability Testing protocols and procedures (Schedule C) and the Quality Agreement (Exhibit B) as applicable, to the extent required to reflect any needed changes to manufacturing and validation methods;
(i) Section 8.3(a)(i) shall apply but only Each party will continue to the extent that the Product conforms to the Specifications, cGMPs or comply with their obligations under Applicable Laws, (ii) Section 8.3(a)(iv) shall apply, and (iii) Section 8.4(a)(v) shall apply but only with respect to all Client Property other than Inventory and Materials (but including Client-Supplied Components).
(c) Law which survive termination of this Agreement; Any completion, termination or expiration of this Agreement or a Product Agreement will not affect any outstanding obligations or payments due prior to the completion, termination or expiration, nor will it prejudice any other remedies that the parties may have under this Agreement or a Product Agreement or any related Capital Equipment Agreement. For greater certainty, completion, termination or expiration of this Agreement or of a Product Agreement for any reason will not affect the obligations and responsibilities of the parties under Articles 6, 10, 11 11, 12 and 13 and Sections 2.21.3, 5.41.5, 5.51.6, 7.3 1.7, 6.2, 6.3, 6.4, 6.5, 6.6, 7.2, 7.3, 7.4, 7.5, 7.6, 7.8, and 7.7 and this Section 8.4 and any other provisions of this Agreement which by their terms are expressed to survive any completion, termination or expiration8.4, all of which survive any completion, termination or expirationtermination.
Appears in 2 contracts
Samples: Master Manufacturing Services Agreement (Akebia Therapeutics, Inc.), Master Manufacturing Services Agreement (Keryx Biopharmaceuticals Inc)
Obligations on Termination. (a) If a Product Agreement is completed, expires, is terminated by Patheon in accordance with Section 8.2(a), (b) or (e), or is terminated by Client in accordance with Section 8.2(c), 8.2(d) or 8.2(f), in whole or in part for any reason, then:
(ia) Client will take delivery of and pay for all undelivered Products that are manufactured and/or packaged in accordance with this Agreement under a Firm OrderOrder and in compliance with the terms of this Agreement, at the Price price in effect at the time the Firm Order was placed;
(iib) Client will purchase, at Patheon's actual cost (including all third party costs incurred by Patheon for the purchase and handling of the Inventory), the Inventory applicable to the Products which was purchased, produced and maintained or produced by Patheon in contemplation of filling Firm Orders or in accordance with Section 5.2;
(iiic) Client will satisfy reimburse Patheon for the purchase price payable under Patheon's orders with suppliers of Components, if the orders were made by Patheon in reliance on Firm Orders or in accordance with Section 5.2;
(ivd) Client acknowledges that no Patheon Competitor will be permitted access to the Manufacturing Site; and
(ve) Client will make commercially reasonable efforts, at its own expense, to remove from Patheon site(s), within [***] 30 days, all unused Active Material and Client-Supplied Components, all applicable Inventory and Materials (whether current or obsolete), supplies, undelivered Product, chattels, equipment or other moveable property owned by Client, related to the Agreement and located at a Patheon site or that is otherwise under Patheon’s care and control (“Client Property”). If Client fails to remove the Client Property within [***] 30 days following the completion, termination, or expiration of the Product Agreement, Client will pay Patheon [***] $100.00 per pallet, per month, one pallet minimum (except that Client will pay $200 per pallet, per month, one pallet minimum, for any of the Client Property that contains controlled substances, requires refrigeration or other special storage requirements) thereafter for storing the Client Property and will assume any third party storage charges invoiced to Patheon regarding the Client Property. Patheon will invoice Client for the storage charges as set forth in Section 5.5 of this Agreement. If Client asks Patheon to destroy any Client Property, Client will be responsible for the cost of destruction.
(b) If a Product Agreement is terminated by Client in accordance with Section 8.2(a) because Patheon has delivered Product that does not conform to the Specifications, cGMPs or Applicable Laws, then (i) Section 8.3(a)(i) shall apply but only to the extent that the Product conforms to the Specifications, cGMPs or Applicable Laws, (ii) Section 8.3(a)(iv) shall apply, and (iii) Section 8.4(a)(v) shall apply but only with respect to all Client Property other than Inventory and Materials (but including Client-Supplied Components).
(c) Any completion, termination or expiration of this Agreement or a Product Agreement will not affect any outstanding obligations or payments due prior to the completion, termination or expiration, nor will it prejudice any other remedies that the parties Parties may have under this Agreement or a Product Agreement or any related Capital Equipment Agreement. For greater certainty, completion, expiration or termination or expiration of this Agreement or of a Product Agreement for any reason will not affect the obligations and responsibilities of the parties Parties under Articles 6, 10, 11 and 13 12 and Sections 2.2, 5.4, 5.55.6, 7.3 6.3, 6.4, 6.5, 6.6, 7.3, 7.4, 8.4, 13.1, 13.2, 13.3, 13.11, 13.15 and 7.7 and this Section 8.4 and any other provisions of this Agreement which by their terms are expressed to survive any completion, termination or expiration13.16, all of which survive any completion, termination or expirationtermination.
Appears in 2 contracts
Samples: Master Manufacturing Services Agreement (Acadia Pharmaceuticals Inc), Master Manufacturing Services Agreement (Acadia Pharmaceuticals Inc)
Obligations on Termination. (a) If a Product this Agreement is completed, expires, is terminated by Patheon in accordance with Section 8.2(a), (b) or (e), or is terminated by Client in accordance with Section 8.2(c), 8.2(d) or 8.2(f), in whole or in part for any reason, then:
(ia) Client will take delivery of and pay for all undelivered Products that are manufactured and/or packaged in accordance with this Agreement under a Firm OrderOrder and comply with their Specifications, at the Price price in effect at the time the Firm Order was placed;
(iib) Client will purchase, at Patheon's ’s cost (including all third party costs incurred by Patheon for the purchase and handling of the Inventory), the Inventory applicable to the Products which was purchased, produced or maintained or produced by Patheon in contemplation of filling Firm Orders or in accordance with Section 5.25.2 prior to notice of termination being given, provided that such Inventory complies with and is maintained in accordance with its Specifications;
(iiic) Client will satisfy the purchase price payable under Patheon's ’s orders with suppliers of Components, if the orders were made by Patheon in reliance on Firm Orders or in *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. accordance with Section 5.2, and the Components comply with and are maintained in accordance with their specifications;
(ivd) Patheon will return to Client or Client’s designee, as noted by Client in writing, all unused Active Materials (with shipping and related expenses, if any, to be borne by Client); and
(e) Client acknowledges that no competitor of Patheon Competitor will be permitted access to the Manufacturing Site; and.
(vf) Client will make commercially reasonable efforts, at its own expense, to remove from Patheon site(s), within [***] daysBusiness Days, all unused Active Material and of Client-Supplied ’s Components, all applicable Inventory and Materials (whether current or obsolete), supplies, undelivered Product, chattels, equipment or other moveable property owned by Client, related to the Agreement and located at a Patheon site or that is otherwise under Patheon’s care and control (“Client Property”). If Client fails to remove the Client Property within [***] days Business Days following the completion, termination, or expiration of the Product Agreement, Agreement Client will pay Patheon $[***] per pallet, per month, one pallet minimum ($[***] per pallet, per month, one pallet minimum, for any of the Client Property that contains controlled substances or requires refrigeration) thereafter for storing the Client Property and will assume any third party storage charges invoiced to Patheon regarding the Client Property. Patheon will invoice Client for the storage charges as set forth in Section 5.5 5.6 of this Agreement. If Client asks Patheon to destroy any Client Property, Client will be responsible for the cost of destruction.
(b) If a Product Agreement is terminated by Client in accordance with Section 8.2(a) because Patheon has delivered Product that does not conform to the Specifications, cGMPs or Applicable Laws, then (i) Section 8.3(a)(i) shall apply but only to the extent that the Product conforms to the Specifications, cGMPs or Applicable Laws, (ii) Section 8.3(a)(iv) shall apply, and (iii) Section 8.4(a)(v) shall apply but only with respect to all Client Property other than Inventory and Materials (but including Client-Supplied Components).
(c) Any completion, termination or expiration of this Agreement or a Product Agreement will not affect any outstanding obligations or payments due hereunder prior to the completion, termination or expiration, nor will it prejudice any other remedies that the parties may have under this Agreement or a Product Agreement or any related Capital Equipment Agreement. For greater certainty, completion, termination or expiration of this Agreement or of a Product Agreement for any reason will not affect the obligations and responsibilities of the parties under Articles 6, 10, 10 and 11 and 13 and Sections 2.2, 5.4, 5.55.6, 7.3 8.4, 13.1, 13.2, 13.3, and 7.7 and this Section 8.4 and any other provisions of this Agreement which by their terms are expressed to survive any completion, termination or expiration13.15, all of which survive any completion, termination or expirationtermination.
Appears in 2 contracts
Samples: Manufacturing Services Agreement (Santarus Inc), Manufacturing Services Agreement (Santarus Inc)
Obligations on Termination. (a) If a Product Agreement is completed, expires, is terminated by Patheon in accordance with Section 8.2(a), (b) or (e), or is terminated by Client in accordance with Section 8.2(c), 8.2(d) or 8.2(f), in whole or in part for any reason, then:
(i) Subject to Article 6, Client will take delivery of and pay for all undelivered Products that are manufactured and/or packaged under a Firm Order in accordance with this Agreement under a Firm OrderAgreement, at the Price in effect at the time the Firm Order was placed;
(ii) Client will purchase, at Patheon's cost (including all third party costs incurred by Patheon for the purchase and handling of the Inventory), the Inventory applicable to the Products which was purchased, produced or maintained or produced by Patheon in contemplation of filling as reasonably necessary to fill Firm Orders or in accordance with Section 5.2;
(iii) Client will satisfy the purchase price payable under Patheon's orders with suppliers of Components, if the orders were made by Patheon in reliance on Firm Orders or in accordance with Section 5.2;
(iv) Client acknowledges that no Patheon Competitor will be permitted access to the Manufacturing Site; and
(v) Client will make commercially reasonable efforts, at its own expense, to remove from Patheon site(s), within [***] days, all unused Active Material and Client-Supplied Components, all applicable Inventory and Materials (whether current or obsolete), supplies, undelivered Product, chattels, equipment or other moveable property owned by Client, related to the Agreement and located at a Patheon site or that is otherwise under Patheon’s care and control (“Client Property”). If Client fails to remove the Client Property within [***] days following the completion, termination, or expiration of the Product Agreement, Client will pay Patheon $[**] / EUR [**] per pallet, per month, one pallet minimum (except that Client will pay $[**] / EUR [**] per pallet, per month, one pallet minimum, for any of the Client Property that contains controlled substances, requires refrigeration or other special storage requirements) thereafter for storing the Client Property and will assume any third party storage charges invoiced to Patheon regarding the Client Property. Patheon will invoice Client for the storage charges as set forth in Section 5.5 of this Agreement. If Client asks Patheon to destroy any Client Property, Client will be responsible for the cost of destruction.
(b) If Upon Client’s request Patheon shall reasonably assist Client for a reasonable period of time in the transfer of the manufacture to a Third Party, including providing all Product Agreement is terminated data and any non-Confidential Information regarding the manufacturing process provided that Client will reimburse Patheon for its fees and all documented costs and out-of-pocket expenses incurred in connection with such assistance (Patheon would provide a quotation for the services that Client requires pursuant to this Section 8.4(b) and on acceptance by Client in accordance with Section 8.2(a) because of the same and signature by the parties, Patheon has delivered Product that does not conform to will provide the Specifications, cGMPs or Applicable Laws, then (i) Section 8.3(a)(i) shall apply but only to the extent that the Product conforms to the Specifications, cGMPs or Applicable Laws, (ii) Section 8.3(a)(iv) shall apply, and (iii) Section 8.4(a)(v) shall apply but only with respect to all Client Property other than Inventory and Materials (but including Client-Supplied Components)services stated therein.
(c) Any completion, termination or expiration of this Agreement or a Product Agreement will not affect any accrued rights or outstanding obligations or payments due prior to the completion, termination or expiration, nor will it prejudice any other remedies that the parties may have under this Agreement or a Product Agreement or any related Capital Equipment Agreement. For greater certainty, completion, termination or expiration of this Agreement or of a Product Agreement for any reason will not affect the obligations and responsibilities of the parties under Articles 6, 10, 10 and 11 and 13 and Sections 2.2, 5.4, 5.5, 7.3 8.4, 13.1, 13.2, 13.3, 13.16 and 7.7 and this Section 8.4 and any other provisions of this Agreement which by their terms are expressed to survive any completion, termination or expiration13.17, all of which survive any completion, termination or expiration.
Appears in 2 contracts
Samples: Master Manufacturing Services Agreement (La Jolla Pharmaceutical Co), Master Manufacturing Services Agreement (Tetraphase Pharmaceuticals Inc)
Obligations on Termination. (a) If a Product this Agreement is completed, expires, is terminated by Patheon in accordance with Section 8.2(a), (b) or (e), or is terminated by Client in accordance with Section 8.2(c), 8.2(d) or 8.2(f), in whole or in part for any reason, then:
(ia) Client will take delivery of and pay for all undelivered Products that are have been manufactured and/or packaged in accordance with this Agreement under a Firm Order, at the Price price in effect at the time the Firm Order was placed;
(iib) Client will purchase, at Patheon's ’s cost (including all third party costs incurred by Patheon for the purchase and handling of the Inventory), the Inventory applicable to the Products which that was purchased, produced or maintained or produced by Patheon for use in contemplation of filling then-current Firm Orders or in accordance with Section 5.2and prior to the notice of termination being given;
(iii) Client will satisfy the purchase price payable under Patheon's orders with suppliers of Components, if the orders were made by Patheon in reliance on Firm Orders or in accordance with Section 5.2;
(ivc) Client acknowledges that no Patheon will not be required to permit a Patheon Competitor will be permitted to access to the Manufacturing Site; and
(vd) Client will make commercially reasonable efforts, at its own expense, to remove from Patheon site(s)the Manufacturing Site, within [***] 30 days, all unused Active Material and Client-Supplied ComponentsMaterial, all applicable Inventory inventory and Materials (whether current or obsolete), supplies, undelivered Product, chattels, equipment or other moveable property owned by Client, related to the Product Agreement and located at a Patheon site Manufacturing Site or that is otherwise under Patheon’s care and control (“Client Property”). If Client fails to remove the Client Property within [***] 30 days following written notice from Patheon describing the nature and location of all Client Property to be removed by Client due to the completion, termination, termination or expiration of the a Product Agreement, Client will pay Patheon $[***] per pallet, per month, one pallet minimum (except that Client will pay $[***] per pallet, per month, one pallet minimum, for any of the Client Property that contains controlled substances, requires refrigeration or other special storage requirements) thereafter for storing the Client Property and will assume any reasonable third party storage charges invoiced to Patheon regarding the Client Property. Patheon will invoice Client for the storage charges as set forth in Section 5.5 of this Agreement. If Client asks Patheon to destroy any Client Property, Client will be responsible for the cost of destruction.
(b) If a Product Agreement is terminated by Client in accordance with Section 8.2(a) because Patheon has delivered Product that does not conform to the Specifications, cGMPs or Applicable Laws, then (i) Section 8.3(a)(i) shall apply but only to the extent that the Product conforms to the Specifications, cGMPs or Applicable Laws, (ii) Section 8.3(a)(iv) shall apply, and (iii) Section 8.4(a)(v) shall apply but only with respect to all Client Property other than Inventory and Materials (but including Client-Supplied Components).
(c) Any completion, termination or expiration of this Agreement or a Product Agreement will not affect any outstanding obligations or payments due that have arisen prior to the completion, termination or expirationtermination, nor will it prejudice any other remedies that the parties may have under this Agreement or a Product Agreement or any related Capital Equipment Agreement. For greater certainty, completion, termination or expiration The provisions of this Agreement or of a Product Agreement for any reason will not affect the obligations and responsibilities of the parties under Articles 6, 7, 9, 10, 11 and 13 12, and Sections 2.2, 4.6, 5.4, 5.5, 7.3 and 7.7 13.1, 13.2, 13.3, 13.9, 13.19, 13.20 and this Section 8.4 and any other provisions 8.4, will survive termination of this Agreement which by their terms are expressed to survive any completion, termination or expiration, all of which survive any completion, termination or expirationAgreement.
Appears in 2 contracts
Samples: Master Manufacturing Services Agreement (Jaguar Animal Health, Inc.), Master Manufacturing Services Agreement (Jaguar Animal Health, Inc.)
Obligations on Termination. (a) If a Product Agreement is completed, expires, is terminated by Patheon in accordance with Section 8.2(a), (b) or (e), or is terminated by Client in accordance with Section 8.2(c), 8.2(d) or 8.2(f), in whole or in part for any reason, then:
(i) Client Indivior will take delivery of and pay for all undelivered Products that are manufactured and/or packaged in accordance with this Agreement under a Firm Order, at the Price in effect at the time the Firm Order was placed;
(ii) Client Indivior will purchase, at Patheon's cost (including all third party costs incurred by Patheon for the purchase purchase, handling, and handling processing of the Inventory), the Inventory applicable to the Products which was purchased, maintained or produced by Patheon in contemplation of filling Firm Orders or in accordance with Section 5.2;
(iii) Client Indivior will satisfy the purchase price payable under Patheon's orders with suppliers of Components, if the orders were made by Patheon in reliance on Firm Orders or in accordance with Section 5.2;
(iv) Client Indivior acknowledges that no Patheon Competitor will be permitted access to the Manufacturing Site; and
(v) Client Indivior will make commercially reasonable efforts, at its own expense, to remove from Patheon site(s)the Manufacturing Site, within [***] days60 days of receipt of written notice, all unused Active Material and ClientIndivior-Supplied Components, all applicable Inventory and Materials (whether current or obsolete), supplies, undelivered Product, chattels, equipment or other moveable property owned by ClientIndivior, related to the Product Agreement and located at a Patheon site Manufacturing Site or that is otherwise under Patheon’s care and control (“Client Indivior Property”). The written notice shall detail the Indivior Property remaining on the Manufacturing Site. If Client Indivior fails to remove Client Indivior Property within such timeframe, Indivior will pay Patheon $[***] per pallet, per month, [***] pallet minimum (except that Indivior will pay $[***] per pallet, per month, [***] pallet minimum, for any of Indivior Property that contains controlled substances, requires refrigeration or other special storage requirements) thereafter for storing Indivior Property and will assume any third party storage charges invoiced to Patheon regarding Indivior Property. Patheon will invoice Indivior for the storage charges as set forth in Section 5 of this Agreement. If Indivior fails to remove Indivior Property within 30 days following the completion, termination, or expiration of the Product Agreement, Client Indivior will pay Patheon [***] for storing Client assume all risk of loss or damage to the stored Indivior Property and it will assume any third party storage charges invoiced be Indivior’s responsibility to Patheon regarding Client Property. Patheon will invoice Client have appropriate insurance coverage in place for the storage charges as set forth in Section 5.5 of this Agreementrisk. If Client Indivior asks Patheon to destroy any Client Indivior Property, Client Indivior will be responsible for the cost of destruction.
(b) If a Upon termination of this Agreement or any Product Agreement is terminated by Client for any reason, Patheon and Indivior will work together in accordance with Section 8.2(a) because Patheon has delivered good faith to discontinue any third party agreements used exclusively to support the Manufacturing Services under this Agreement or applicable Product that does not conform to the Specifications, cGMPs or Applicable Laws, then (i) Section 8.3(a)(i) shall apply but only to the extent that the Product conforms to the Specifications, cGMPs or Applicable Laws, (ii) Section 8.3(a)(iv) shall apply, and (iii) Section 8.4(a)(v) shall apply but only with respect to all Client Property other than Inventory and Materials (but including Client-Supplied Components)Agreement.
(c) Any completion, termination or expiration of this Agreement or a Product Agreement will not affect any outstanding obligations or payments due prior to the completion, termination or expiration, nor will it prejudice any other remedies that the parties may have under this Agreement or a Product Agreement or any related Capital Equipment Agreement. For greater certainty, completion, termination or expiration of this Agreement or of a Product Agreement for any reason will not affect the obligations and responsibilities of the parties under Articles 6, 10, 11 11, 12, and 13 14, and Sections 2.25.3, 5.4, 5.57.5(ii), 7.3 8.3, 13.1, 13.2, 13.3, 13.9, 13.10, 13.11, 13.15, 13.16, and 7.7 and this Section 8.4 and any other provisions of this Agreement which by their terms are expressed to survive any completion, termination or expiration13.17, all of which survive any completion, termination or expiration.
Appears in 2 contracts
Samples: Master Manufacturing Services Agreement (Indivior PLC), Master Manufacturing Services Agreement (Indivior PLC)
Obligations on Termination. (a) If a Product Agreement is completed, expires, is terminated by Patheon in accordance with Section 8.2(a), (b) or (e), or is terminated by Client in accordance with Section 8.2(c), 8.2(d) or 8.2(f), in whole or in part for any reason, then:
(ia) Client will take delivery of and pay for all undelivered Products that are manufactured and/or packaged in accordance with this Agreement under a Firm Order, at the Price price in effect at the time the Firm Order was placed, subject to Client’s right to reject any such Product as described in Article 6 of this Agreement;
(iib) Client will purchase, at Patheon's ’s cost (including all third party costs incurred by Patheon for the purchase and handling of the Inventory), the Inventory applicable to the Products which was purchased, produced or maintained or produced by Patheon in contemplation of filling Firm Orders or in accordance with Section 5.2, but not including Components which Patheon can use in its other Manufacturing operations and not including any Inventory that has been stored or otherwise maintained in an environment that a Regulatory Authority has determined, or would reasonably determine, is not cGMP compliant;
(iiic) Client will satisfy the purchase price payable under Patheon's ’s orders with suppliers of Components, if the orders were made by Patheon in reliance on Firm Orders or in accordance with Section 5.2;
(ivd) Client acknowledges that no Patheon Competitor will be permitted access to the Manufacturing Site; and
(ve) Client will make commercially reasonable efforts, at its own expense, to remove from Patheon site(s), within [...***...] days, all unused Active Material and Client-Supplied Components, all applicable Inventory and Materials (whether current or obsolete), supplies, undelivered Product, chattels, equipment [E]equipment or other moveable property owned by Client, related to the Agreement and located at a Patheon site or that is otherwise under Patheon’s care and control (“Client Property”). If Client fails to remove the Client Property within […***…] days following the completion, termination, or expiration of the Product Agreement, Client will pay Patheon $[…***…] per pallet, per month, one pallet minimum (except that Client will pay $[…***…] per pallet, per month, one pallet minimum, for any of the Client Property that contains controlled substances, requires refrigeration or other special storage requirements) thereafter for storing the Client Property and will assume any third party storage charges invoiced to Patheon regarding the Client Property. Patheon will invoice Client for the storage charges as set forth in Section 5.5 5.6 of this Agreement. If Client asks Patheon to destroy any Client Property, Client will be responsible for the cost of destruction.
(bf) If The parties will reasonably cooperate to support the transfer of the manufacture of the Products to a Product Agreement is terminated by Client in accordance with Section 8.2(a) because Patheon has delivered Product that does not conform to the Specifications, cGMPs or Applicable Laws, then (i) Section 8.3(a)(i) shall apply but only to the extent that the Product conforms to the Specifications, cGMPs or Applicable Laws, (ii) Section 8.3(a)(iv) shall apply, and (iii) Section 8.4(a)(v) shall apply but only with respect to all Client Property other than Inventory and Materials (but including Client-Supplied Components).
(c) third party manufacturer. Any completion, termination or expiration of this Agreement or a Product Agreement will not affect any outstanding obligations or payments due prior to the completion, termination or expiration, nor will it prejudice any other remedies that the parties may have under this Agreement or a Product Agreement or any related Capital Equipment Agreement. For greater certainty, completion, termination or expiration of this Agreement or of a Product Agreement for any reason will not affect the obligations and responsibilities of the parties under Articles 6, 10, 10 and 11 and 13 and Sections 2.2, 5.4, 5.55.6, 7.3 8.4, 13.1, 13.2, 13.3, and 7.7 and this Section 8.4 and any other provisions of this Agreement which by their terms are expressed to survive any completion, termination or expiration13.16, all of which survive any completion, termination or expirationtermination.
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (Horizon Pharma, Inc.)
Obligations on Termination. (a) If a Product this Agreement is completed, expires, is terminated by Patheon in accordance with Section 8.2(a), (b) or (e), or is terminated by Client in accordance with Section 8.2(c), 8.2(d) or 8.2(f), in whole or in part for any reason, then:
(ia) Patheon will cease the manufacture of Products and will terminate any unfilled orders with third parties that Patheon may have previously submitted with respect to Components, to the extent such orders may be terminated or revoked;
(b) Client will (i) take delivery of and pay for all any undelivered Products that are manufactured and/or packaged in accordance with this Agreement under a Firm OrderProducts, at the Price in effect at the time the Firm Order order for such Products was placed, and (ii) take delivery of any unused Active Materials. Patheon will cooperate with Client in the surrender, delivery and transfer of these items as promptly as is commercially reasonable, with any shipping and related expenses to be borne by Client;
(iic) Client will purchase, at Patheon's cost ’s out-of-pocket costs (including all third party such costs incurred by Patheon for the purchase and handling of the Inventory), the Inventory applicable to the Products which was purchased, produced or maintained or produced by Patheon in contemplation of filling Firm Orders or in accordance with Section 5.25.2 prior to notice of termination being given;
(iiid) Client will satisfy the purchase price payable under Patheon's ’s non-cancellable orders with suppliers of Components, if the orders were made by Patheon prior to notice of termination being given and in reliance on Firm Orders or in accordance with Section 5.2;
(ive) Client acknowledges that no will purchase from Patheon Competitor will any existing work-in-process held by Patheon, at a price to be permitted access mutually agreed in good faith. But if Client terminates this Agreement under Section 8.3(a), Client, at its option, may purchase from Patheon any existing work-in-progress held by Patheon, at a price to the Manufacturing Site; andbe mutually agreed in good faith.
(vf) Client will make commercially reasonable efforts, at its own expense, to remove from Patheon site(s), within [***] days30 Business Days, all unused Active Material and of Client-Supplied ’s Components, all applicable Inventory and Materials (whether current or obsolete), supplies, undelivered Product, chattels, capital equipment or other moveable property owned by Client, related to the Agreement and located at a Patheon site or that is otherwise under Patheon’s care and control (“Client Property”). If Client fails to remove the Client Property within [***] days 30 Business Days following the completion, termination, or expiration of the Product Agreement, Agreement Client will pay Patheon [***] $100.00 per pallet, per month, one pallet minimum ($200 per pallet, per month, one pallet minimum, for any of the Client Property that contains controlled substances or requires refrigeration) thereafter for storing the Client Property and will assume any third party storage charges invoiced to Patheon regarding the Client Property. Patheon will invoice Client for the storage charges as set forth in Section 5.5 5.6 of this Agreement. If ; and
(g) upon the request of Client, and at Client’s expense, Patheon will provide such assistance as is reasonably necessary to assist Client asks in transferring the manufacture of the Product to another facility; provided, however, that Client acknowledges that no competitor of Patheon to destroy any Client Property, Client will be responsible for the cost of destruction.
(b) If a Product Agreement is terminated by Client in accordance with Section 8.2(a) because Patheon has delivered Product that does not conform permitted access to the Specifications, cGMPs or Applicable Laws, then (i) Section 8.3(a)(i) shall apply but only to the extent that the Product conforms to the Specifications, cGMPs or Applicable Laws, (ii) Section 8.3(a)(iv) shall apply, Manufacturing Site; and (iii) Section 8.4(a)(v) shall apply but only with respect to all Client Property other than Inventory and Materials (but including Client-Supplied Components).
(c) Any completion, termination or expiration of this Agreement or a Product Agreement will not affect any outstanding obligations or payments due hereunder prior to the completion, termination or expiration, nor will it prejudice any other remedies that the parties may have under this Agreement or a Product Agreement or any related Capital Equipment Agreement. For greater certainty, completion, termination or expiration of this Agreement or of a Product Agreement for any reason will not affect the obligations and responsibilities of the parties under Articles 6, 10, 10 and 11 and 13 and Sections 2.2, 5.4, 5.5, 7.3 8.4, 13.1, 13.2, 13.3, and 7.7 and this Section 8.4 and any other provisions of this Agreement which by their terms are expressed to survive any completion, termination or expiration13.15, all of which survive any completion, termination or expirationtermination.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Orexigen Therapeutics, Inc.)
Obligations on Termination. (a) If a Product this Agreement is completed, expires, is terminated by Patheon in accordance with Section 8.2(a), (b) or (e), expires or is terminated by Client in accordance with Section 8.2(c), 8.2(d) or 8.2(f), in whole or in part for any reason, then:then (in addition to any other remedies Patheon may have in the event of default by Customer):
(ia) Client will Customer shall take delivery of and pay for all undelivered Products that are manufactured and/or packaged in accordance with this Agreement under pursuant to a Firm Order, at the Price price in effect at the time the Firm Order was placed;
(iib) Client will Customer shall purchase, at Patheon's external cost (including all third party costs incurred by Patheon for associated to the purchase and handling disposition of the such Inventory), the Inventory applicable to the Products which was purchased, produced or maintained or produced by Patheon in contemplation of filling Firm Orders or in accordance with Section 5.25.2 prior to notice of termination being given;
(iiic) Client will Customer shall satisfy the purchase price payable under pursuant to Patheon's orders with suppliers of Components, if the provided such orders were made by Patheon in reliance on Firm Orders or in accordance with Section 5.2;; [ * ] = 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.
(ivd) Client Patheon shall promptly return to Customer all unused Active Materials (with shipping and related expenses, if any, to be borne by Customer); and
(e) Customer acknowledges that no competitor of Patheon Competitor will shall be permitted access to the Manufacturing Site; and.
(vf) Client will Customer shall make commercially reasonable efforts, at its own expense, to remove from Patheon site(s), within [***] days[ * ], all unused Active Material and Client-Supplied of Customer’s Components, all applicable Inventory and Materials (whether current or obsolete), supplies, undelivered Product, chattels, equipment Equipment or other moveable property owned by ClientCustomer, related to the Agreement and located at a Patheon Patheon’s site or that is otherwise under Patheon’s care and control (“Client Customer Property”). If Client fails Customer shall pay to remove Client Patheon a [ * ] per square foot per month storage fee for all Customer Property within [***] days remaining at Patheon’s site(s) after the above mentioned term following the completion, termination, termination or expiration of the Product Agreement, Client will pay Patheon [***] for storing Client Property Agreement and will assume any third party storage charges invoiced to Patheon regarding Client any such Customer Property. Patheon will invoice Client Customer for the such storage charges as set forth in Section according to the provisions of section 5.5 of this Agreement. If Client asks Patheon to destroy any Client Property, Client will be responsible for the cost of destruction.
(b) If a Product Agreement is terminated by Client in accordance with Section 8.2(a) because Patheon has delivered Product that does not conform to the Specifications, cGMPs or Applicable Laws, then (i) Section 8.3(a)(i) shall apply but only to the extent that the Product conforms to the Specifications, cGMPs or Applicable Laws, (ii) Section 8.3(a)(iv) shall apply, and (iii) Section 8.4(a)(v) shall apply but only with respect to all Client Property other than Inventory and Materials (but including Client-Supplied Components).
(c) Any completion, termination or expiration of this Agreement or a Product Agreement will shall not affect any outstanding obligations or payments due hereunder prior to the completion, such termination or expiration, nor will shall it prejudice any other remedies that the parties may have under this Agreement or a Product Agreement or any related Capital Equipment Agreement. For greater certainty, completion, termination or expiration of this Agreement or of a Product Agreement for any reason will shall not affect the obligations and responsibilities of the parties under Articles 6, 10, 11 and 13 and Sections 2.2, 5.4, 5.5, 7.3 and 7.7 and this Section 8.4 and any other provisions which are explicitly or impliedly intended to survive termination or expiry of this Agreement which by their terms are expressed to and such provisions shall survive any completion, termination or expiration, all of which survive any completion, termination or expirationtermination.
Appears in 1 contract
Obligations on Termination. (a) If a Product Agreement is completed, expires, is terminated by Patheon in accordance with Section 8.2(a), (b) or (e), or is terminated by Client in accordance with Section 8.2(c), 8.2(d) or 8.2(f), in whole or in part for any reason, then:
(ia) Client will take delivery of and pay for all undelivered Products that are manufactured and/or packaged in accordance with this Agreement under a Firm OrderOrder and in compliance with the terms of this Agreement, at the Price price in effect at the time the Firm Order was placed;
(iib) Client will purchase, at Patheon's ’s actual cost (including all third party costs incurred by Patheon for the purchase and handling of the Inventory), the Inventory applicable to the Products which was purchased, produced and maintained or produced by Patheon in contemplation of filling Firm Orders or in accordance with Section 5.2;
(iiic) Client will satisfy reimburse Patheon for the purchase price payable under Patheon's ’s orders with suppliers of Components, if the orders were made by Patheon in reliance on Firm Orders or in accordance with Section 5.2;
(ivd) Client acknowledges that no Patheon Competitor will be permitted access to the Manufacturing Site; and
(ve) Client will make commercially reasonable efforts, at its own expense, to remove from Patheon site(s), within [***] 30 days, all unused Active Material and Client-Supplied Components, all applicable Inventory and Materials (whether current or obsolete), supplies, undelivered Product, chattels, equipment or other moveable property owned by Client, related to the Agreement and located at a Patheon site or that is otherwise under Patheon’s care and control (“Client Property”). If Client fails to remove the Client Property within [***] 30 days following the completion, termination, or expiration of the Product Agreement, Client will pay Patheon [***] $100.00 per pallet, per month, one pallet minimum (except that Client will pay $200 per pallet, per month, one pallet minimum, for any of the Client Property that contains controlled substances, requires refrigeration or other special storage requirements) thereafter for storing the Client Property and will assume any third party storage charges invoiced to Patheon regarding the Client Property. Patheon will invoice Client for the storage charges as set forth in Section 5.5 of this Agreement. If Client asks Patheon to destroy any Client Property, Client will be responsible for the cost of destruction.
(b) If a Product Agreement is terminated by Client in accordance with Section 8.2(a) because Patheon has delivered Product that does not conform to the Specifications, cGMPs or Applicable Laws, then (i) Section 8.3(a)(i) shall apply but only to the extent that the Product conforms to the Specifications, cGMPs or Applicable Laws, (ii) Section 8.3(a)(iv) shall apply, and (iii) Section 8.4(a)(v) shall apply but only with respect to all Client Property other than Inventory and Materials (but including Client-Supplied Components).
(c) Any completion, termination or expiration of this Agreement or a Product Agreement will not affect any outstanding obligations or payments due prior to the completion, termination or expiration, nor will it prejudice any other remedies that the parties Parties may have under this Agreement or a Product Agreement or any related Capital Equipment Agreement. For greater certainty, completion, expiration or termination or expiration of this Agreement or of a Product Agreement for any reason will not affect the obligations and responsibilities of the parties Parties under Articles 6, 10, 11 and 13 12 and Sections 2.2, 5.4, 5.55.6, 7.3 6.3, 6.4, 6.5, 6.6, 7.3, 7.4, 8.4, 13.1, 13.2, 13.3, 13.11, 13.15 and 7.7 and this Section 8.4 and any other provisions of this Agreement which by their terms are expressed to survive any completion, termination or expiration13.16, all of which survive any completion, termination or expirationtermination.
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (Acadia Pharmaceuticals Inc)
Obligations on Termination. (a) If a Product this Agreement is completed, expires, is terminated by Patheon in accordance with Section 8.2(a), (b) or (e), or is terminated by Client in accordance with Section 8.2(c), 8.2(d) or 8.2(f), in whole or in part for any reason, then:
(i) Client will take delivery of and pay for all undelivered Products that are manufactured and/or packaged in accordance with this Agreement under a Firm Order, at the Price in effect at the time the Firm Order was placed;
(ii) Client will purchase, at Patheon's ’s cost (including all third party costs incurred by Patheon for the purchase purchase, handling, and handling processing of the Inventory), the Inventory applicable to the Products which was purchased, maintained or produced by Patheon in contemplation of filling Firm Orders or in accordance with Section 5.2;
(iii) Client will satisfy the purchase price payable under Patheon's ’s orders with suppliers of Components, if the orders were made by Patheon in reliance on Firm Orders or in accordance with Section 5.2;
(iv) Client acknowledges that no Patheon Competitor will be permitted access to the Manufacturing Site; and
(v) Client will make commercially reasonable efforts, at its own expense, to remove from Patheon site(s), within [***] days, all unused Active Material and Client-Supplied Components, all applicable Inventory and Materials (whether current or obsolete), supplies, undelivered Product, chattels, equipment or other moveable property owned by Client, related to the Agreement and located at a Patheon site or that is otherwise under Patheon’s care and control (“Client Property”). If Client fails to remove Client Property within [***] days following the completion, termination, or expiration of the Product this Agreement, Client will pay Patheon EURO [**] per pallet, per month, one pallet minimum (except that Client will pay EURO [**] per pallet, per month, one pallet minimum, for any of Client Property that contains controlled substances, requires refrigeration or other special storage requirements) thereafter for storing Client Property and will assume any third party storage charges invoiced to Patheon regarding Client Property. Patheon will invoice Client for the storage charges as set forth in Section 5.5 of this Agreement. If Client fails to remove Client Property within [**] days following the completion, termination, or expiration of the Product Agreement, Client will assume all risk of loss or damage to the stored Client Property and it will be Client’s responsibility to have appropriate insurance coverage in place for this risk. If Client asks Patheon to destroy any Client Property, Client will be responsible for the cost of destruction.
(b) If a Product Agreement is terminated by Client in accordance with Section 8.2(a) because Patheon has delivered Product that does not conform to the Specifications, cGMPs or Applicable Laws, then (i) Section 8.3(a)(i) shall apply but only to the extent that the Product conforms to the Specifications, cGMPs or Applicable Laws, (ii) Section 8.3(a)(iv) shall apply, and (iii) Section 8.4(a)(v) shall apply but only with respect to all Client Property other than Inventory and Materials (but including Client-Supplied Components).
(c) Any completion, termination or expiration of this Agreement or a Product Agreement will not affect any outstanding obligations or payments due prior to the completion, termination or expiration, nor will it prejudice any other remedies that the parties may have under this Agreement or a Product Agreement or any related Capital Equipment Agreement. For greater certainty, completion, termination or expiration of this Agreement or of a Product Agreement for any reason will not affect the obligations and responsibilities of the parties under Articles 6, 10, 10 and 11 and 13 and Sections 2.2, 5.4, 5.5, 7.3 8.3, 13.1, 13.2, 13.3 and 7.7 and this Section 8.4 and any other provisions of this Agreement which by their terms are expressed to survive any completion, termination or expiration13.16, all of which survive any completion, termination or expiration.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Nabriva Therapeutics PLC)
Obligations on Termination. (a) If a Product this Agreement is completed, expires, is terminated by Patheon in accordance with Section 8.2(a), (b) or (e), or is terminated by Client in accordance with Section 8.2(c), 8.2(d) or 8.2(f), in whole or in part for any reason, then:
(ia) Client will take delivery of and pay for all undelivered Products that are manufactured and/or or packaged in accordance with this Agreement under a Firm Order, at the Price in effect at the time the Firm Order was placed;released; 17 CFR 240.24b-2, confidential information has been omitted in places marked “[***]” and has been filed separately with the Securities and Exchange Commission pursuant to a Confidential Treatment Application filed with the Commission.
(iib) Client will purchase, at Patheon's cost purchase all Inventory that was purchased (including all third party costs incurred by Patheon or will be purchased under existing unfulfilled orders for the purchase and handling of the InventoryComponents), the Inventory applicable to the Products which was purchased, maintained or produced by Patheon in contemplation of filling Firm Orders or in accordance with Section 5.2, at Patheon's cost (including all costs incurred by Patheon for the purchase, handling, and processing of the Inventory);
(iiic) Client will satisfy the purchase price payable under Patheon's orders with suppliers of Components, if the orders were made by Patheon in reliance on Firm Orders or in accordance with Section 5.2;
(iv) Client acknowledges that no Patheon Competitor will be permitted access to the Manufacturing Site; and
(v) Client will make commercially reasonable effortsClient, at its own expense, to will remove from Patheon site(s)the Manufacturing Site, within [***] daysdays following the completion, all unused Active Material and Client-Supplied Componentstermination, or expiration of this Agreement, all applicable Inventory and Materials (whether current or obsolete), supplies, undelivered Product, chattels, equipment or other moveable property owned by Client, related to the Agreement and located at a Patheon site the Manufacturing Site or that is otherwise under Patheon’s care and control (“Client Property”). If Client fails to Client, at its own expense, will remove Client Property from the Manufacturing Site, within [***] days following the completion, termination, or expiration of this Agreement, all equipment or other moveable property owned by Client related to the Product AgreementAgreement and located at the Manufacturing Site or that is otherwise under Patheon’s care and control (“Client Property”).If Client fails to remove Client Property within the applicable [***] day period, Client will pay Patheon [***] per pallet, per month, one pallet minimum after that for storing Client Property and will assume any third party storage charges invoiced to Patheon regarding Client PropertyProperty (which Patheon may incur at its discretion). Patheon may ship Client Property to Client or to an external warehouse at Client’s risk and expense. Patheon will invoice Client for the these storage charges as set forth out in Section 5.5 5.3 of this Agreement. If Client fails to remove Client Property within the applicable [***] days following the completion, termination, or expiration of this Agreement, Client will assume all risk of loss or damage to the stored Client Property and it will be Client’s responsibility to have appropriate insurance coverage in place for this risk. If Client asks Patheon to destroy any Client Property, Client will be responsible for the cost of destruction.; and
(bd) If a Product Agreement is terminated by Client in accordance with Section 8.2(a) because Patheon has delivered Product that does not conform to the Specifications, cGMPs or Applicable Laws, then (i) Section 8.3(a)(i) shall apply but only to the extent that the Product conforms to the Specifications, cGMPs or Applicable Laws, (ii) Section 8.3(a)(iv) shall apply, and (iii) Section 8.4(a)(v) shall apply but only with respect to all Client Property other than Inventory and Materials (but including Client-Supplied Components).
(c) Any any completion, termination or expiration of this Agreement or a Product Agreement will not affect any prior outstanding obligations or payments due prior to the completion, termination or expiration, nor will it prejudice any other remedies that the parties may have under this Agreement or a Product Agreement or any related Capital Equipment Agreement. For greater certainty, completionCompletion, termination or expiration of this Agreement or of a Product Agreement for any reason will not affect the obligations and responsibilities of the parties under Articles 6Sections 5.1(e), 10, 11 and 13 and Sections 2.25.1(f), 5.4, 5.5, 7.3 8.3, 10, 11, 12, 13.14, 13.15 and 7.7 and this Section 8.4 and any other provisions of this Agreement which by their terms are expressed to survive any completion, termination or expiration13.16, all of which survive any completion, termination or expiration, as well as any other provisions that are by implication or otherwise intended to survive any completion, termination or expiration. Where Patheon has agreed to provide stability services beyond the final supply of Product, the relevant provisions of this Agreement will survive for the agreed duration of those stability services.
Appears in 1 contract
Obligations on Termination. (a) If a Product this Agreement is completed, expires, is terminated by Patheon in accordance with Section 8.2(a), (b) or (e), or is terminated by Client in accordance with Section 8.2(c), 8.2(d) or 8.2(f), in whole or in part for any reason, then:
(ia) Patheon will cease the manufacture of Products and will terminate any unfilled orders with third parties that Patheon may have previously submitted with respect to Components, to the extent such orders may be terminated or revoked using commercially reasonable efforts.
(b) Client will take delivery of and pay for all undelivered Products that are manufactured and/or packaged in accordance with this Agreement under a Firm Order, at the Price price in effect at the time the Firm Order was placed;
(iic) Client will purchase, at Patheon's ’s direct out-of-pocket cost (including all third party costs incurred by Patheon for the purchase and handling of the Inventory), the Inventory applicable to the Products which was purchased, produced or maintained or produced by Patheon in contemplation of filling Firm Orders or in accordance with Section 5.2;
(iiid) Client will satisfy the purchase price payable under Patheon's ’s orders with suppliers of Components, if the orders were made by Patheon in reliance on Firm Orders or in accordance with Section 5.2;
(ive) Patheon will return to Client all unused Active Materials (with shipping and related expenses, if any, to be borne by Client); and
(f) Client acknowledges that no Patheon Competitor competitor will be permitted access to the Manufacturing Site; and.
(vg) Client will make commercially reasonable efforts, at its own expense, to remove from Patheon site(s), within fifteen Business Days, all of Client’s Components, Inventory and [***] days, all unused Active Material Confidential treatment requested; certain information omitted and Client-Supplied Components, all applicable Inventory and filed separately with the SEC. Materials (whether current or obsolete), supplies, undelivered Product, chattels, equipment or other moveable property owned by Client, related to the Agreement and located at a Patheon site or that is otherwise under Patheon’s care and control (“Client Property”). If Client fails to remove the Client Property within [***] days Business Days following the completion, termination, or expiration of the Product Agreement, Agreement Client will pay Patheon $[**] per pallet, per month, one pallet minimum ($[*] per pallet, per month, one pallet minimum, for any of the Client Property that contains controlled substances or requires refrigeration) thereafter for storing the Client Property and will assume any third party storage charges invoiced to Patheon regarding the Client Property. Patheon will invoice Client for the storage charges as set forth in Section 5.5 5.6 of this Agreement. If Client asks Patheon to destroy any Client Property, Client will be responsible for the cost of destruction.
(b) If a Product Agreement is terminated by Client in accordance with Section 8.2(a) because Patheon has delivered Product that does not conform to the Specifications, cGMPs or Applicable Laws, then (i) Section 8.3(a)(i) shall apply but only to the extent that the Product conforms to the Specifications, cGMPs or Applicable Laws, (ii) Section 8.3(a)(iv) shall apply, and (iii) Section 8.4(a)(v) shall apply but only with respect to all Client Property other than Inventory and Materials (but including Client-Supplied Components).
(c) Any completion, termination or expiration of this Agreement or a Product Agreement will not affect any outstanding obligations or payments due hereunder prior to the completion, termination or expiration, nor will it prejudice any other remedies that the parties may have under this Agreement or a Product Agreement or any related Capital Equipment Agreement. For greater certainty, completion, termination or expiration of this Agreement or of a Product Agreement for any reason will not affect the obligations and responsibilities of the parties under Articles 6, 10, 10 and 11 and 13 and Sections 2.2, 5.4, 5.55.6, 7.3 8.4, 13.1, 13.2, 13.3, and 7.7 and this Section 8.4 and any other provisions of this Agreement which by their terms are expressed to survive any completion, termination or expiration13.15, all of which survive any completion, termination or expirationtermination.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Chelsea Therapeutics International, Ltd.)
Obligations on Termination. (a) If a Product this Agreement is completed, expires, is terminated by Patheon in accordance with Section 8.2(a), (b) or (e), expires or is terminated by Client in accordance with Section 8.2(c), 8.2(d) or 8.2(f), in whole or in part for any reason, then:then following the expiration or termination of this Agreement, or the end of the Wind-Down Period, if applicable (in addition to any other remedies either party may have in the event of default by the other party):
(ia) the Client will shall take delivery of and pay for (in accordance with Section 5.6) all undelivered Products that are manufactured and/or packaged in accordance with this Agreement under pursuant to a Firm Order, at the Price price in effect at the time the Firm Order was placed;.
(iib) the Client will shall purchase, at Patheon's ’s cost (including all third party costs incurred by Patheon for the purchase and handling of the Inventory)****, the Inventory applicable to the Products remaining Components which was purchased, maintained or produced were purchased by Patheon in contemplation of filling Firm Orders or in accordance with Section 5.2;
5.2 prior to notice of termination being given to the extent that such Components cannot be returned or used to produce product for another client; and (iiiii) Client will satisfy the purchase price payable under Patheon's orders with suppliers of Components, if the orders were made all remaining work-in-process produced by Patheon in reliance on contemplation of filling Firm Orders or prior to notice of termination being given. If the parties are unable to agree on what costs incurred by Patheon are reasonable, then the parties shall resolve such issue in accordance with Section 5.2;12.1
(ivc) the Client acknowledges that no competitor of Patheon Competitor will (as defined in Section 8.2(d)) shall be permitted access to the Manufacturing Site; and.
(vd) Client will make commercially reasonable efforts, at its own expenseexpense but with Patheon’s reasonable cooperation, to remove from Patheon site(s), within [***] days*, all unused Active Material and of Client-Supplied ’s Components, all applicable Inventory Active Materials and Materials (whether current or obsolete), supplies, undelivered ProductProduct and works-in-progress, chattels, equipment or other moveable property owned by Client, related to the Agreement and located at a Patheon site or that is otherwise under Patheon’s care and control (“Client Property”). If Client fails to remove the Client Property within [***] days * following the completion, termination, termination or expiration of the Product AgreementAgreement (or following the end of the Wind-Down Period, if applicable), Client will pay Patheon [***] * per pallet, per month, one pallet minimum (**** per pallet, per month, one pallet minimum, for any of the Client Property that contains controlled substances or requires refrigeration) thereafter for storing the Client Property and will assume any third party storage charges invoiced to Patheon regarding the Client Property. Patheon will invoice Client for the storage charges as set forth in Section 5.5 5.6 of this Agreement. If Client asks Patheon to destroy any Client Property, Client will be responsible for the cost of destruction.
(b) If a Product this Agreement expires or is terminated by Client in accordance with Section 8.2(a) because Patheon has delivered Product that does not conform to the Specifications, cGMPs or Applicable Lawswhole for any reason, then (i) Section 8.3(a)(i) in addition to any other remedies the Client may have in the event of default by Patheon), Patheon shall apply but only **** CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. return to the extent that the Product conforms to the Specifications, cGMPs or Applicable Laws, (ii) Section 8.3(a)(iv) shall apply, and (iii) Section 8.4(a)(v) shall apply but only with respect to Client all Client Property other than Inventory (with shipping and Materials (but including related expenses, if any, to be borne by the Client), following such expiration or termination or the end of the Wind-Supplied Components).
(c) Any completionDown Period, if applicable. In addition, for a period of **** after the termination or expiration of this Agreement (the “Wind-Down Period”), Client may continue to order Manufacturing, and Patheon shall continue to provide Manufacturing in accordance with such orders from Client (if any), in each case subject to the terms and conditions of this Agreement. In the event of termination by Patheon pursuant to Section 8.2(a) due to Client’s failure to pay undisputed amounts, Patheon may require that Client pay such amounts before filling any Firm Orders and may require that Client pre-pay for any Manufacturing provided during the Wind-Down Period. Furthermore, upon reasonable request by Client, Patheon will use commercially reasonable and good faith efforts to discuss with Client and come to an agreement with Client with respect to the terms for the performance of other transition services that are reasonably requested by Client. Without limiting the foregoing, upon termination of this Agreement by Client pursuant to sections 8.1, 8.2 (a) or a Product (b) or 13.7, Client shall have the right, where applicable, to ****. In such circumstances, Patheon and its affiliates will co-operate, and use its commercially reasonable efforts to cause its approved subcontractors to co-operate, in good faith with Client to ****. Any termination or expiration of this Agreement will shall not affect any outstanding obligations or payments due hereunder prior to the completion, such termination or expiration, nor will shall it prejudice any other remedies that the parties may have under this Agreement or a Product Agreement or any related Capital Equipment Agreement. For greater certainty, completion, termination or expiration of this Agreement or of a Product Agreement for any reason will shall not affect the obligations and responsibilities of the parties under pursuant to Articles 6, 8, 9, 10, 11 11, 12 and 13 and Sections 2.21.1, 5.47.3, 5.57.4, 7.3 7.5, 7.6 and 7.7 and this Section 8.4 and any other provisions of this Agreement which by their terms are expressed to survive any completion, termination or expiration7.7, all of which survive any completion, termination or expirationtermination.
Appears in 1 contract
Samples: Manufacturing Agreement (Vanda Pharmaceuticals Inc.)
Obligations on Termination. (a) If a Product Agreement is completed, expires, is terminated by Patheon in accordance with Section 8.2(a), (b) or (e), or is terminated by Client in accordance with Section 8.2(c), 8.2(d) or 8.2(f), in whole or in part for any reason, then:
(ia) Client will take delivery of and pay for all undelivered Products Product that are was manufactured and/or packaged in accordance compliance with the Product Agreement and this Agreement under a Firm Order, Order at the Price price in effect at the time the Firm Order was placed;
(iib) Client will purchase, at Patheon's cost (including all third party costs incurred by Patheon plus a [*] handling fee for the purchase and handling of the InventoryComponents), the Inventory applicable to the Products which was purchased, produced or maintained or produced by Patheon in contemplation of filling reliance on Firm Orders or in accordance with Section 5.25.2 prior to notice of termination being given;
(iiic) Client will satisfy the purchase price payable under Patheon's orders with suppliers of Components, if the orders were made by Patheon in reliance on Firm Orders or in accordance with Section 5.2;
(ivd) Patheon will return to Client all unused Active Materials (with shipping and related expenses, if any, to be borne by Client).
(e) Client acknowledges that no Patheon Competitor will be permitted access to the Manufacturing Site; and
(vf) Client will make commercially reasonable efforts, at its own expense, to remove from Patheon site(s), within [***] days, all unused Active Material and Client-Supplied Components, all applicable Inventory and Materials (whether current or obsolete), supplies, undelivered Product, chattels, equipment or other moveable property owned by Client, related to the Agreement and located at a Patheon site or that is otherwise under Patheon’s care and control (“Client Property”). If Client fails to remove the Client Property within [***] days following the completion, termination, or expiration of the Product Agreement, Client will pay Patheon [**] per pallet, per month, [*] minimum (except that Client will pay [*] per pallet, per month, [*] minimum, for any of the Client Property that contains controlled substances, requires refrigeration or other special storage requirements) thereafter for storing the Client Property and will assume any third party storage charges invoiced to Patheon regarding the Client Property. Patheon will invoice Client for the storage charges as set forth in Section 5.5 of this Agreement.
(g) In connection with the expiration or termination of this Agreement or any Product Agreement hereunder, at Client’s request, Patheon will provide assistance reasonably required to transfer the Manufacturing Services. If Such assistance may include, without limitation, providing documents required for the Manufacturing Services, attending meetings (in person or via teleconference), and subject to the confidentiality provisions hereof, hosting a Manufacturing Site visit. Except in cases of termination by Client asks Patheon pursuant to destroy any Client PropertySection 8.2, Client will be responsible reimburse Patheon for the cost of destruction.
(b) If a Product Agreement is terminated by Client its costs incurred in providing such assistance in accordance with Section 8.2(a) because Patheon has delivered Product that does not conform to a tech transfer plan and budget negotiated in good faith and agreed upon by the Specifications, cGMPs or Applicable Laws, then (i) Section 8.3(a)(i) shall apply but only to the extent that the Product conforms to the Specifications, cGMPs or Applicable Laws, (ii) Section 8.3(a)(iv) shall apply, and (iii) Section 8.4(a)(v) shall apply but only with respect to all Client Property other than Inventory and Materials (but including Client-Supplied Components).
(c) Any completionparties. Any, termination or expiration of this Agreement or a Product Agreement will not affect any outstanding obligations or payments due prior to the completion, termination or expiration, nor will it prejudice any other remedies that the parties may have under this Agreement or a Product Agreement or any related Capital Equipment Agreement. For greater certainty, completion, the termination or expiration of this Agreement or of a Product Agreement for any reason will not affect the obligations and responsibilities of the parties under Articles 69, 10, 10 and 11 and 13 and Sections 2.2, 5.4, 5.5, 7.3 8.5, 13.1, 13.2 and 7.7 and this Section 8.4 and any other provisions of this Agreement which by their terms are expressed to survive any completion, termination or expiration13.3, all of which survive any completion, termination or expiration.
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (Jazz Pharmaceuticals PLC)
Obligations on Termination. (a) If a Product Agreement is completed, expires, is terminated by Patheon in accordance with Section 8.2(a), (b) or (e), or is terminated by Client in accordance with Section 8.2(c), 8.2(d) or 8.2(f), in whole or in part for any reason, then:
(ia) Client will take delivery of and pay for all undelivered Products that are manufactured and/or or packaged in accordance with this Agreement under a Firm Order, at the Price in effect at the time the Firm Order was placedreleased;
(iib) Client will purchase, at Patheon's cost purchase all Inventory that was purchased (including all third party costs incurred by Patheon or will be purchased under existing unfulfilled orders for the purchase and handling of the InventoryComponents), the Inventory applicable to the Products which was purchased, maintained or produced by Patheon in contemplation of filling Firm Orders or in accordance with Section 5.2, at Patheon’s cost (including all costs incurred by Patheon for the purchase, handling, and processing of the Inventory);
(iiic) Client will satisfy the purchase price payable under Patheon's orders with suppliers of Components, if the orders were made by Patheon in reliance on Firm Orders or in accordance with Section 5.2;
(iv) Client acknowledges that no Patheon Competitor will be permitted access to the Manufacturing Site; and
(v) Client will make commercially reasonable effortsClient, at its own expense, to will remove from Patheon site(s)the Manufacturing Site, within [***] daysfollowing the completion, termination, or expiration of the Product Agreement, all unused Active Material API and Client-Supplied Components, all applicable Inventory and Materials (whether current or obsolete), supplies, undelivered Product, chattels, equipment or other moveable property owned by Client, related to the Agreement and located at a Patheon site the Manufacturing Site or that is otherwise under Patheon’s care and control (“Client Property”). If Client fails to remove Client Property within the [***] days following period, which may be extended by the completionClient for unforeseen circumstances, termination, or expiration of the Product Agreementfor up to an additional [***] period, Client will then pay Patheon [***] per pallet, per month, one pallet minimum (except that Client will pay [***] per pallet, per month, one pallet minimum, for any of Client Property that contains controlled substances, requires refrigeration or other special storage requirements) after that for storing Client Property and will assume any third party storage charges invoiced to Patheon regarding Client PropertyProperty (which Patheon may incur at its discretion). Patheon may ship Client Property to Client or to an external warehouse at Client’s risk and expense. Patheon will invoice Client for the these storage charges as set forth out in Section 5.5 5.3 of this Agreement. If Client fails to remove Client Property within [***] following the completion, termination, or expiration of the Product Agreement, which may be extended by the Client for unforeseen circumstances, for up to an additional [***] period, Client will assume all risk of loss or damage to the stored Client Property and it will be Client’s responsibility to have appropriate insurance coverage in place for this risk. If Client asks Patheon to destroy any Client Property, Client will be responsible for the cost of destruction.; and
(bd) If a Product Agreement is terminated by Client in accordance with Section 8.2(a) because Patheon has delivered Product that does not conform to the Specifications, cGMPs or Applicable Laws, then (i) Section 8.3(a)(i) shall apply but only to the extent that the Product conforms to the Specifications, cGMPs or Applicable Laws, (ii) Section 8.3(a)(iv) shall apply, and (iii) Section 8.4(a)(v) shall apply but only with respect to all Client Property other than Inventory and Materials (but including Client-Supplied Components).
(c) Any any completion, termination or expiration of this Agreement or a Product Agreement will not affect any prior outstanding obligations or undisputed payments due prior to the completion, termination or expiration, nor will it prejudice any other remedies that the parties may have under this Agreement or a Product Agreement or any related Capital Equipment Agreement. For greater certainty, completionCompletion, termination or expiration of this Agreement or of a Product Agreement for any reason will not affect the obligations and responsibilities of the parties under Articles 6Sections 5.1(e), 10, 11 and 13 and Sections 2.25.1(f), 5.4, 5.5, 7.3 8.3, 10, 11, 12, 13.14, 13.15 and 7.7 and 13.16, all of which shall survive any completion, termination or expiration of this Section 8.4 and Agreement of a Product Agreement, as well as any other provisions of this Agreement which that are by their terms are expressed implication or otherwise intended to survive any completion, termination or expiration. Where Patheon has agreed to provide stability services beyond the final supply of Product, all the relevant provisions of which this Agreement will survive any completion, termination or expirationfor the agreed duration of those stability services.
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (Amylyx Pharmaceuticals, Inc.)
Obligations on Termination. (a) If a Product Agreement is completed, expires, is terminated by Patheon in accordance with Section 8.2(a), (b) or (e), expires or is terminated by Client in accordance with Section 8.2(c), 8.2(d) or 8.2(f), in whole or in part for any reason, then:then (in addition to any other remedies Patheon may have in the event of default by Éclat):
(ia) Client will Éclat shall take delivery of and pay for all undelivered Products that are manufactured and/or packaged in accordance with this Agreement under pursuant to a Firm Order, at the Price price in effect at the time the Firm Order was placed;
(iib) Client will Éclat shall purchase, at Patheon's ’s cost (including all third party costs incurred by Patheon for in connection with the purchase and handling of the such Inventory), the Inventory applicable to the Products which was purchased, produced or maintained or produced by Patheon in contemplation of filling Firm Orders or in accordance with Section 5.25.2 prior to notice of termination being given;
(iiic) Client will Éclat shall satisfy the purchase price payable under pursuant to Patheon's ’s orders with suppliers of ComponentsComponents unique to, if the or specifically purchased for, Éclat’s product(s), provided such orders were made by Patheon in reliance on Firm Orders or in accordance with Section 5.2;
(ivd) Client Patheon shall return to Éclat all unused Active Materials (with shipping and related expenses, if any, to be borne by Éclat); and
(e) Éclat acknowledges that no competitor of Patheon Competitor will shall be permitted access to the Manufacturing Site; and.
(vf) Client will Éclat shall make commercially reasonable efforts, at its own expense, to remove from Patheon site(s), within [***] daysten (10) Business Days, all unused Active Material and Client-Supplied of Éclat’s Components, all applicable Inventory and Materials (whether current or obsolete), supplies, undelivered Product, chattels, equipment Equipment or other moveable property owned by ClientÉclat, related to the Product Agreement and located at a Patheon Patheon’s site or that is otherwise under Patheon’s care and control (“Client Éclat Property”). If Client fails Éclat shall pay to remove Client Patheon a thirty dollar ($30.00) per square foot per month storage fee for all Éclat Property within [***] days remaining at Patheon’s site(s) after the tenth (10th) Business Day following the completion, termination, termination or expiration of the Product Agreement, Client will pay Patheon [***] for storing Client Property Agreement and will assume any third party storage charges invoiced to Patheon regarding Client any such Éclat Property. Patheon will invoice Client Éclat for the such storage charges as set forth in Section according to the provisions of section 5.5 of this Agreement. If Client asks Patheon to destroy any Client Property, Client will be responsible for the cost of destruction.
(b) If a Product Agreement is terminated by Client in accordance with Section 8.2(a) because Patheon has delivered Product that does not conform to the Specifications, cGMPs or Applicable Laws, then (i) Section 8.3(a)(i) shall apply but only to the extent that the Product conforms to the Specifications, cGMPs or Applicable Laws, (ii) Section 8.3(a)(iv) shall apply, and (iii) Section 8.4(a)(v) shall apply but only with respect to all Client Property other than Inventory and Materials (but including Client-Supplied Components).
(c) Any completion, termination or expiration of this Agreement or a Product Agreement will shall not affect any outstanding obligations or payments due hereunder prior to the completion, such termination or expiration, nor will shall it prejudice any other remedies that the parties may have under this Agreement or a the Product Agreement or any related Capital Equipment Agreement. For greater certainty, completion, termination or expiration of this Agreement or of a Product Agreement for any reason will shall not affect the obligations and responsibilities of the parties under Articles 6, 10, 11 and 13 and Sections 2.2, 5.4, 5.5, 7.3 and 7.7 and this Section 8.4 and any other provisions which are explicitly or impliedly intended to survive termination or expiry of the Product Agreement (as stated in this Agreement which by their terms are expressed to or said Product Agreement) and such provisions shall survive any completion, termination or expiration, all of which survive any completion, termination or expirationtermination.
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (Avadel Pharmaceuticals PLC)
Obligations on Termination. (a) If a Product Agreement is completed, expires, is terminated by Patheon in accordance with Section 8.2(a), (b) or (e), or is terminated by Client in accordance with Section 8.2(c), 8.2(d) or 8.2(f), in whole or in part for any reason, then:
(i) Client will take delivery of and pay for all undelivered Products that are manufactured and/or packaged in accordance with this Agreement under a Firm Order, at the Price in effect at the time the Firm Order was placed;
(ii) Client will purchase, at Patheon's ’s cost (including all third party costs incurred by Patheon for the purchase and handling of the Inventory), the Inventory applicable to the Products which was purchased, maintained or produced by Patheon in contemplation of filling Firm Orders or in accordance with Section 5.2;
(iii) Client will satisfy the purchase price payable under Patheon's ’s orders with suppliers of Components, if the orders were made by Patheon in reliance on Firm Orders or in accordance with Section 5.2;
(iv) Client acknowledges that no Patheon Competitor will be permitted access to the Manufacturing Site; and
(v) Client will make commercially reasonable efforts, at its own expense, to remove from Patheon site(s), within [***] days, all unused Active Material and Client-Supplied Components, all applicable Inventory and Materials (whether current or obsolete), supplies, undelivered Product, chattels, equipment or other moveable property owned by Client, related to the Agreement and located at a Patheon site or that is otherwise under Patheon’s care and control (“Client Property”). If Client fails to remove Client Property within [***] days following the completion, termination, or expiration of the Product Agreement, Client will pay Patheon [***] for storing Client Property and will assume any third party storage charges invoiced to Patheon regarding Client Property. Patheon will invoice Client for the storage charges as set forth in Section 5.5 of this Agreement. If Client asks Patheon to destroy any Client Property, Client will be responsible for the cost of destruction.
(b) If a Product Agreement is terminated by Client in accordance with Section 8.2(a) because Patheon has delivered Product that does not conform to the Specifications, cGMPs or Applicable Laws, then (i) Section 8.3(a)(i) shall apply but only to the extent that the Product conforms to the Specifications, cGMPs or Applicable Laws, (ii) Section 8.3(a)(iv) shall apply, and (iii) Section 8.4(a)(v) shall apply but only with respect to all Client Property other than Inventory and Materials (but including Client-Supplied Components).
(c) Any completion, termination or expiration of this Agreement or a Product Agreement will not affect any outstanding obligations or payments due prior to the completion, termination or expiration, nor will it prejudice any other remedies that the parties may have under this Agreement or a Product Agreement or any related Capital Equipment Agreement. For greater certainty, completion, termination or expiration of this Agreement or of a Product Agreement for any reason will not affect the obligations and responsibilities of the parties under Articles 6, 10, 11 and 13 and Sections 2.2, 5.4, 5.5, 7.3 and 7.7 and this Section 8.4 and any other provisions of this Agreement which by their terms are expressed to survive any completion, termination or expiration, all of which survive any completion, termination or expiration.
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (Baudax Bio, Inc.)
Obligations on Termination. (a) If a Product this Agreement is completed, expires, is terminated by Patheon in accordance with Section 8.2(a), (b) or (e), expires or is terminated by Client in accordance with Section 8.2(c), 8.2(d) or 8.2(f), in whole or in part for any reason, then:then (in addition to any other remedies Patheon may have if Client defaults):
(ia) Client will take delivery of and pay for all undelivered Products that are manufactured and/or packaged in accordance with this Agreement under a Firm Order, at the Price price in effect at the time the Firm Order was placed;
(iib) Client will purchase, at Patheon's cost (including all third party costs incurred by Patheon for the purchase and handling of the Inventory), the Inventory applicable to the Products which was purchased, produced or maintained or produced by Patheon in contemplation of filling Firm Orders or in accordance with Section 5.25.2 prior to notice of termination being given;
(iiic) Client will satisfy the purchase price payable under Patheon's non-cancellable orders with suppliers of Components, if the provided such orders were made by Patheon in reliance on Firm Orders or in accordance with Section 5.2;
(ivd) Patheon will return to Client all unused API (with shipping and related expenses, if any, to be borne by Client); and
(e) Client acknowledges that no Competitor of Patheon Competitor will be permitted access to the Manufacturing Site; andprovided, however that this does not include Client’s Licensor, Elan Corporation or Client’s Licensee, Biogen Idec;
(vf) Client will make commercially reasonable efforts, at its own expense, to remove from Patheon site(s), within [***] days**], all unused Active Material and of Client-Supplied ’s Components, all applicable Inventory and Materials (whether current or obsolete), supplies, undelivered Product, chattels, equipment or other moveable property owned by Client, related to the Agreement and located at a Patheon site or that is otherwise under Patheon’s care and control (“Client Property”). If Client fails to remove the Client Property within [***] days five Business Days following the completion, termination, termination or expiration of the Product Agreement, Agreement Client will pay Patheon [*****] per pallet, per month, one pallet minimum ([*****] per pallet, per month, one pallet minimum, for any of the Client Property this contains controlled substances or requires refrigeration) thereafter for storing the Client Property and will assume any third party storage charges invoiced to Patheon regarding the Client Property. Patheon will invoice Client for the storage charges as set forth in according to the provisions of Section 5.5 of this Agreement. If Client asks Patheon to destroy any Client Property, Client will be responsible for the cost of destruction.
(b) If a Product Agreement is terminated by Client in accordance with Section 8.2(a) because Patheon has delivered Product that does not conform to the Specifications, cGMPs or Applicable Laws, then (i) Section 8.3(a)(i) shall apply but only to the extent that the Product conforms to the Specifications, cGMPs or Applicable Laws, (ii) Section 8.3(a)(iv) shall apply, and (iii) Section 8.4(a)(v) shall apply but only with respect to all Client Property other than Inventory and Materials (but including Client-Supplied Components).
(c) Any completion, termination or expiration of this Agreement or a Product Agreement will not affect any outstanding obligations or payments due hereunder prior to the completion, termination or expiration, nor will it prejudice any other remedies that the parties may have under this Agreement or a Product Agreement or any related Capital Equipment Agreement. For greater certainty, completion, termination or expiration of this Agreement or of a Product Agreement for any reason will not affect the obligations and responsibilities of the parties under Articles 6, 10, 10 and 11 and 13 and Sections 2.2, 5.4, 5.55.6, 7.3 8.4, 13.1, 13.2, 13.3 and 7.7 and this Section 8.4 and any other provisions of this Agreement which by their terms are expressed to survive any completion, termination or expiration13.15, all of which survive any completion, termination or expirationtermination.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Acorda Therapeutics Inc)
Obligations on Termination. (a) If a Product Agreement is completed, expires, is terminated by Patheon in accordance with Section 8.2(a), (b) or (e), or is terminated by Client in accordance with Section 8.2(c), 8.2(d) or 8.2(f), in whole or in part for any reason, then:
(ia) Client will take delivery of and pay for all undelivered Products Product that are was manufactured and/or packaged in accordance compliance with the Product Agreement and this Agreement under a Firm Order, Order at the Price price in effect at the time the Firm Order was placed;
(iib) Client will purchase, at Patheon's cost (including all third party costs incurred by Patheon plus a [*] handling fee for the purchase and handling of the InventoryComponents), the Inventory applicable to the Products which was purchased, produced or maintained or produced by Patheon in contemplation of filling reliance on Firm Orders or in accordance with Section 5.25.2 prior to notice of termination being given;
(iiic) Client will satisfy the purchase price payable under Patheon's orders with suppliers of Components, if the orders were made by Patheon in reliance on Firm Orders or in accordance with Section 5.2;
(ivd) Patheon will return to Client all unused Active Materials (with shipping and related expenses, if any, to be borne by Client).
(e) Client acknowledges that no Patheon Competitor will be permitted access to the Manufacturing Site; and
(vf) Client will make commercially reasonable efforts, at its own expense, to remove from Patheon site(s), within [***] days, all unused Active Material and Client-Supplied Components, all applicable Inventory and Materials (whether current or obsolete), supplies, undelivered Product, chattels, equipment or other moveable property owned by Client, related to the Agreement and located at a Patheon site or that is otherwise under Patheon’s care and control (“Client Property”). If Client fails to remove the Client Property within [***] days following the completion, termination, or expiration of the Product Agreement, Client will pay Patheon [**] per pallet, per month, [*] minimum (except that Client will pay [*] per pallet, per month, [*] minimum, for any of the Client Property that contains controlled substances, requires refrigeration or other special storage requirements) thereafter for storing the Client Property and will assume any third party storage charges invoiced to Patheon regarding the Client Property. Patheon will invoice Client for the storage charges as set forth in Section 5.5 of this Agreement. If Client asks Patheon to destroy any Client Property, Client will be responsible for the cost of destruction.
(bg) If a Product Agreement is terminated by Client in accordance In connection with Section 8.2(a) because Patheon has delivered Product that does not conform to the Specifications, cGMPs expiration or Applicable Laws, then (i) Section 8.3(a)(i) shall apply but only to the extent that the Product conforms to the Specifications, cGMPs or Applicable Laws, (ii) Section 8.3(a)(iv) shall apply, and (iii) Section 8.4(a)(v) shall apply but only with respect to all Client Property other than Inventory and Materials (but including Client-Supplied Components).
(c) Any completion, termination or expiration of this Agreement or a any Product Agreement hereunder, at Client’s request, Patheon will not affect any outstanding obligations provide assistance reasonably required to transfer the Manufacturing Services. Such assistance may include, without limitation, providing documents required for the Manufacturing Services, attending meetings (in person or payments due prior via teleconference), and subject to the completionconfidentiality provisions hereof, hosting a Manufacturing Site visit. Except in cases of termination or expirationby Client pursuant to Section 8.2, nor Client will it prejudice any other remedies that the parties may have under this Agreement or a Product Agreement or any related Capital Equipment Agreement. For greater certainty, completion, termination or expiration of this Agreement or of a Product Agreement reimburse Patheon for any reason will not affect the obligations and responsibilities of the parties under Articles 6, 10, 11 and 13 and Sections 2.2, 5.4, 5.5, 7.3 and 7.7 and this Section 8.4 and any other provisions of this Agreement which by their terms are expressed to survive any completion, termination or expiration, all of which survive any completion, termination or expiration.its costs incurred in providing
Appears in 1 contract
Samples: Manufacturing Services Agreement
Obligations on Termination. (a) If a Product Agreement is completed, expires, is terminated by Patheon in accordance with Section 8.2(a), (b) or (e), or is terminated by Client in accordance with Section 8.2(c), 8.2(d) or 8.2(f), in whole or in part for any reason, then:
(i) Client will take delivery of and pay for all undelivered Products that are manufactured and/or packaged in accordance with this Agreement under a Firm Order, at the Price in effect at the time the Firm Order was placed;
(ii) Client will purchase, at Patheon's ’s cost (including all third party costs incurred by Patheon for the purchase purchase, handling, and handling processing of the Inventory), the Inventory applicable to the Products which was purchased, maintained or produced by Patheon in contemplation of filling Firm Orders or in accordance with Section 5.2;
(iii) Client will satisfy the purchase price payable under Patheon's ’s orders with suppliers of Components, if the orders were made by Patheon in reliance on Firm Orders or in accordance with Section 5.2;
(iv) Client acknowledges that no Patheon Competitor will be permitted access to the Manufacturing Site; and
(v) Client will make commercially reasonable efforts, at its own expense, to remove from Patheon site(s), within […***…] days, all unused Active Material and Client-Supplied Components, all applicable Inventory and Materials (whether current or obsolete), supplies, undelivered Product, chattels, equipment or other moveable property owned by Client, related to the Agreement and located at a Patheon site or that is otherwise under Patheon’s care and control (“Client Property”). If Client fails to remove Client Property within […***…] days following the completion, termination, or expiration of the Product Agreement, Client will pay Patheon $[…***…] per pallet, per month, one pallet minimum (except that Client will pay $[…***…] per pallet, per month, one pallet minimum, for any of Client Property that contains controlled substances, requires refrigeration or other special storage requirements) thereafter for storing Client Property and will assume any third party storage charges invoiced to Patheon regarding Client Property. Patheon will invoice Client for the storage charges as set forth in Section 5.5 of this Agreement. If Client fails to remove Client Property within […***…] days following the completion, termination, or expiration of the Product Agreement, Client will assume all risk of loss or damage to the stored Client Property and it will be Client’s responsibility to have appropriate insurance coverage in place for this risk. If Client asks Patheon to destroy any Client Property, Client will be responsible for the cost of destruction.
(b) If a Product Agreement is terminated by Client in accordance with Section 8.2(a) because Patheon has delivered Product that does not conform to the Specifications, cGMPs or Applicable Laws, then (i) Section 8.3(a)(i) shall apply but only to the extent that the Product conforms to the Specifications, cGMPs or Applicable Laws, (ii) Section 8.3(a)(iv) shall apply, and (iii) Section 8.4(a)(v) shall apply but only with respect to all Client Property other than Inventory and Materials (but including Client-Supplied Components).
(c) Any completion, termination or expiration of this Agreement or a Product Agreement will not affect any outstanding obligations or payments due prior to the completion, termination or expiration, nor will it prejudice any other remedies that the parties may have under this Agreement or a Product Agreement or any related Capital Equipment Agreement. For greater certainty, completion, termination or expiration of this Agreement or of a Product Agreement for any reason will not affect the obligations and responsibilities of the parties under Articles 6, 10, 10 and 11 and 13 and Sections 2.2, 5.4, 5.5, 7.3 8.3, 13.1, 13.2, 13.3 and 7.7 and this Section 8.4 and any other provisions of this Agreement which by their terms are expressed to survive any completion, termination or expiration13.16, all of which survive any completion, termination or expiration.
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (Neurocrine Biosciences Inc)
Obligations on Termination. (a) If a Product Agreement is completed, expires, is terminated by Patheon in accordance with Section 8.2(a), (b) or (e), or is terminated by Client in accordance with Section 8.2(c), 8.2(d) or 8.2(f), in whole or in part for any reason, then:
(ia) Client will take delivery of and pay for all undelivered Products that are manufactured and/or packaged in accordance with this Agreement under a Firm Order, at the Price price in effect at the time the Firm Order was placed, subject to Client's right to reject any such Product as described in Article 6 of this Agreement;
(iib) Client will purchase, at Patheon's cost (including all third party costs incurred by Patheon for the purchase and handling of the Inventory), the Inventory applicable to the Products which was purchased, produced or maintained or produced by Patheon in contemplation of filling Firm Orders or in accordance with Section 5.2, but not including Components which Patheon can use in its other Manufacturing operations and not including any Inventory that has been stored or otherwise maintained in an environment that a Regulatory Authority has determined, or would reasonably determine, is not cGMP compliant;
(iiic) Client will satisfy the purchase price payable under Patheon's orders with suppliers of Components, if the orders were made by Patheon in reliance on Firm Orders or in accordance with Section 5.2;
(ivd) Client acknowledges that no Patheon Competitor will be permitted access to the Manufacturing Site; and
(ve) Client will make commercially reasonable efforts, at its own expense, to remove from Patheon site(s), within [***] days, all unused Active Material and Client-Supplied Components, all applicable Inventory and Materials (whether current or obsolete), supplies, undelivered Product, chattels, equipment Equipment or other moveable property owned by Client, related to the Agreement and located at a Patheon site or that is otherwise under Patheon’s 's care and control (“"Client Property”"). If Client fails to remove the Client Property within [***] days following the completion, termination, or expiration of the Product Agreement, Client will pay Patheon $[***] per pallet, per month, one pallet minimum (except that Client will pay $[***] per pallet, per month, one pallet minimum, for any of the Client Property that contains controlled substances, requires refrigeration or other special storage requirements) thereafter for storing the Client Property and will assume any third party storage charges invoiced to Patheon regarding the Client Property. Patheon will invoice Client for the storage charges as set forth in Section 5.5 5.6 of this Agreement. If Client asks Patheon to destroy any Client Property, Client will be responsible for the cost of destruction.
(bf) If The parties will reasonably cooperate to support the transfer of the manufacture of the Products to a Product Agreement is terminated by Client in accordance with Section 8.2(a) because Patheon has delivered Product that does not conform to the Specifications, cGMPs or Applicable Laws, then (i) Section 8.3(a)(i) shall apply but only to the extent that the Product conforms to the Specifications, cGMPs or Applicable Laws, (ii) Section 8.3(a)(iv) shall apply, and (iii) Section 8.4(a)(v) shall apply but only with respect to all Client Property other than Inventory and Materials (but including Client-Supplied Components).
(c) third party manufacturer. Any completion, termination or expiration of this Agreement or a Product Agreement will not affect any outstanding obligations or payments due prior to the completion, termination or expiration, nor will it prejudice any other remedies that the parties may have under this Agreement or a Product Agreement or any related Capital Equipment Agreement. For greater certainty, completion, termination or expiration of this Agreement or of a Product Agreement for any reason will not affect the obligations and responsibilities of the parties under Articles 6, 10, 10 and 11 and 13 and Sections 2.2, 5.4, 5.55.6, 7.3 8.4, 13.1, 13.2, 13.3, and 7.7 and this Section 8.4 and any other provisions of this Agreement which by their terms are expressed to survive any completion, termination or expiration13.16, all of which survive any completion, termination or expirationtermination.
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (Horizon Therapeutics Public LTD Co)
Obligations on Termination. (a) If a Product this Agreement is completed, expires, is terminated by Patheon in accordance with Section 8.2(a), (b) or (e), expires or is terminated by Client in accordance with Section 8.2(c), 8.2(d) or 8.2(f), in whole or in part for any reason, then:
(ib) Client will take delivery of and pay for all undelivered Products that are manufactured and/or or packaged in accordance with this Agreement under a Firm Order, at the Price in effect at the time the Firm Order was placedreleased;
(iic) Client will purchase, at Patheon's cost purchase all Inventory that was purchased (including all third party costs incurred by Patheon or will be purchased under existing unfulfilled orders for the purchase and handling of the InventoryComponents), the Inventory applicable to the Products which was purchased, maintained or produced by Patheon in contemplation of filling Firm Orders or in accordance with Section 5.2, at Patheon's cost (including all costs incurred by Patheon for the purchase, handling, and processing of the Inventory);
(iiid) Client will satisfy Unless otherwise agreed by the purchase price payable under Patheon's orders with suppliers of Componentsparties in writing, if the orders were made by Patheon in reliance on Firm Orders or in accordance with Section 5.2;
(iv) Client acknowledges that no Patheon Competitor will be permitted access to the Manufacturing Site; and
(v) Client will make commercially reasonable effortsClient, at its own expense, to will remove from Patheon site(s)the Manufacturing Site, within [***] daysfollowing the termination or expiration of this Agreement, all unused Active Material API and Client-Supplied Components, all applicable Inventory and Materials (whether current or obsolete), supplies, undelivered Product, chattels, equipment or other moveable property owned by Client, Client related to the Agreement and located at a Patheon site the Manufacturing Site or that is otherwise under Patheon’s care and control (“Client Property”). If Client fails to remove Client Property within the [***] days following the completion, termination, or expiration of the Product Agreementperiod, Client will pay Patheon [**], per month, [**] minimum after that for storing Client Property and will assume any third party storage charges invoiced to Patheon regarding Client Property[**]. Patheon will invoice may ship Client for Property to Client or to an external warehouse [**]. If Client fails to remove Client Property within [**] following the storage charges as set forth in Section 5.5 termination or expiration of this Agreement, Client will [**] the stored Client Property and it will be [**]. If Client asks Patheon to destroy any Client Property, Client will be responsible for the cost of destruction.; and
(be) If With exception to any termination for a Product material breach under this Agreement is terminated by Client in accordance with Section 8.2(a) because Patheon has delivered Product that does not conform to the SpecificationsPatheon, cGMPs or Applicable Laws, then (i) Section 8.3(a)(i) shall apply but only to the extent that the Product conforms to the Specifications, cGMPs or Applicable Laws, (ii) Section 8.3(a)(iv) shall apply, and (iii) Section 8.4(a)(v) shall apply but only with respect to all Client Property other than Inventory and Materials (but including Client-Supplied Components).
(c) Any completion, any termination or expiration of this Agreement or a Product Agreement will not affect any prior outstanding obligations or payments due prior to the completion, termination or expiration, nor will it prejudice any other remedies that the parties may have under this Agreement or a Product Agreement or any related Capital Equipment Agreement. For greater certainty, completion, termination Termination or expiration of this Agreement or of a Product Agreement for any reason will not affect the obligations and responsibilities of the parties under Articles 6Sections 5.1(e), 5.4, 5.5,8.3, 10, 11 11, 12, 13.15, 13.16 and 13 and Sections 2.2, 5.4, 5.5, 7.3 and 7.7 and this Section 8.4 and any other provisions of this Agreement which by their terms are expressed to survive any completion, termination or expiration13.17, all of which survive any completion, termination or expiration, as well as any other provisions that are by implication or otherwise intended to survive any termination or expiration. If Patheon agrees to provide stability services following the termination or expiration of this Agreement, the relevant provisions of this Agreement will survive for the agreed duration of those stability services.
(f) No later than [**] following completion or permanent cessation of the Manufacturing Services at the applicable Manufacturing Site, Client will: (a) ensure that any regulatory filings relating to the Product are withdrawn or amended to remove all references to the Manufacturing Site and, as applicable, Patheon or its Affiliates and their facilities (except in an historic context); and (b) provide to Patheon written confirmation of its compliance with this Section. If this time is not sufficient to meet the requirements of certain Regulatory Authorities, despite Client’s best efforts, then Patheon may agree to extend the period based on the written reassurances of Client.
Appears in 1 contract
Obligations on Termination. (a) If a Product Agreement is completed, expires, is terminated by Patheon in accordance with Section 8.2(a), (b) or (e), or is terminated by Client in accordance with Section 8.2(c), 8.2(d) or 8.2(f), in whole or in part for any reason, then:
(i) Client will take delivery of and pay for all undelivered Products that are manufactured and/or packaged in accordance with this Agreement (i.e. that are conforming Products) that are not unmarketable due to the failure of Patheon or the Manufacturing Site to comply with Specifications, Applicable Laws or cGMPs under a Firm Order, at the Price in effect at the time the Firm Order was placed[* * *];
(ii) Unless Client terminates this Agreement pursuant to [* * *], Client will purchase, at Patheon's cost (including [* * *] all third party costs incurred by Patheon for the purchase and handling of the Inventory), the cGMP-compliant Inventory applicable to the Products which was purchased, maintained or produced by Patheon in contemplation of filling Firm Orders or in accordance with Section 5.2;. [* * *]
(iii) Unless Client terminates this Agreement pursuant to [* * *], Client will satisfy the purchase price payable under Patheon's orders with suppliers of cGMP-compliant Components, if the supplier orders are not able to be cancelled or reduced and were made by Patheon in reliance on Firm Orders or in accordance with Section 5.2;, and all such Components for which Client has paid the purchase price shall be transferred to Client. [* * *]
(iv) Patheon shall provide reasonable support and documentation to Client acknowledges to enable Client to perform a technology transfer of the Product manufacturing process to a third party manufacturer. [* * *];
(v) In the event that no a technology transfer to a third party manufacturer is required on Client’s proper notice of termination of this Agreement, this Agreement shall be extended for a reasonable period to cover the technology transfer and to give the third party manufacturer sufficient time to manufacture Product of sufficient quantity and quality to replace Patheon’s supply. For the avoidance of doubt, all the terms of this Agreement shall continue to apply during this period and all activities must be completed promptly by Client and its third party manufacturer. Client must give Patheon Competitor will be permitted access to accurate monthly written updates on the Manufacturing Siteduration of the extension, which cannot exceed [* * *]; and
(vvi) Client will make commercially reasonable efforts, at its own expense, to remove from Patheon site(s), within [* * ***] days], all unused Active Material and Client-Supplied Components, all applicable Inventory and Materials (whether current or obsolete), supplies, undelivered Product, chattels, equipment or other moveable property owned by Client, related to the Agreement and located at a Patheon site or that is otherwise under Patheon’s care and control (“Client Property”). If Client fails to remove Client Property within [*** * *] days following the completion, termination, or expiration of the Product Agreement, Client will pay Patheon [*** * *] thereafter for storing Client Property and will assume any third party storage charges invoiced to Patheon regarding Client Property. Patheon will invoice Client for the storage charges as set forth in Section 5.5 of this Agreement. If Client fails to remove Client Property within [* * *] following the completion, termination, or expiration of the Product Agreement, Client will assume all risk of loss or damage to the stored Client Property and it will be Client’s responsibility to have appropriate insurance coverage in place for this risk. If Client asks Patheon to destroy any Client Property, Client will be responsible for the cost of destruction.
(b) If a Product Agreement is terminated by Client in accordance with Section 8.2(a) because Patheon has delivered Product that does not conform to the Specifications, cGMPs or Applicable Laws, then (i) Section 8.3(a)(i) shall apply but only to the extent that the Product conforms to the Specifications, cGMPs or Applicable Laws, (ii) Section 8.3(a)(iv) shall apply, and (iii) Section 8.4(a)(v) shall apply but only with respect to all Client Property other than Inventory and Materials (but including Client-Supplied Components).
(c) Any completion, termination or expiration of this Agreement or a Product Agreement will not affect any outstanding obligations or payments due prior to the completion, termination or expiration, nor will it prejudice any other remedies that the parties Parties may have under this Agreement or a Product Agreement or any related Capital Equipment Agreement. For greater certainty, completion, termination or expiration of this Agreement or of a Product Agreement for any reason will not affect the obligations and responsibilities of the parties Parties under Articles 6Sections 1.3 (Definitions) through 1.6 (Singular Terms) (solely to the extent necessary to give meaning to the other surviving sections), 10Section 5.5 (Invoices and Payment), 11 ARTICLE 6 (Product Claims and 13 Recalls), Section 7.3 (Records and Sections 2.2Accounting by Patheon), 5.4Section 7.4 (Inspection), 5.5, 7.3 and 7.7 and this Section 8.4 8.3 (Obligations on Termination), ARTICLE 10 (Remedies and any other provisions of this Agreement which by their terms are expressed to survive any completionIndemnities), termination or expirationARTICLE 11 (Confidentiality), ARTICLE 12 (Dispute Resolution) and ARTICLE 13 (Miscellaneous), all of which survive any completion, termination or expiration.
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (Paratek Pharmaceuticals, Inc.)
Obligations on Termination. (a) If a Product Agreement is completed, expires, is terminated by Patheon in accordance with Section 8.2(a), (b) or (e), or is terminated by Client in accordance with Section 8.2(c), 8.2(d) or 8.2(f), in whole or in part for any reason, then:
(ia) Client will take delivery of and pay for all undelivered Products that are manufactured and/or packaged in accordance with this Agreement under a Firm Order, at the Price price in effect at the time the Firm Order was placed, subject to Client’s right to reject any such Product as described in Article 6 of this Agreement;
(iib) Client will purchase, at Patheon's ’s cost (including all third party costs incurred by Patheon for the purchase and handling of the Inventory), the Inventory applicable to the Products which was purchased, produced or maintained or produced by Patheon in contemplation of filling Firm Orders or in accordance with Section 5.2, but not including Components which Patheon can use in its other Manufacturing operations and not including any Inventory that has been stored or otherwise maintained in an environment that a Regulatory Authority has determined, or would reasonably determine, is not cGMP compliant;
(iiic) Client will satisfy the purchase price payable under Patheon's ’s orders with suppliers of Components, if the orders were made by Patheon in reliance on Firm Orders or in accordance with Section 5.2;
(ivd) Client acknowledges that no Patheon Competitor will be permitted access to the Manufacturing Site; and
(ve) Client will make commercially reasonable efforts, at its own expense, to remove from Patheon site(s), within [***] 30 days, all unused Active Material and Client-Supplied Components, all applicable Inventory and Materials (whether current or obsolete), supplies, undelivered Product, chattels, equipment [E]equipment or other moveable property owned by Client, related to the Agreement and located at a Patheon site or that is otherwise under Patheon’s care and control (“Client Property”). If Client fails to remove the Client Property within [***] 30 days following the completion, termination, or expiration of the Product Agreement, Client will pay Patheon [***] $100.00 per pallet, per month, one pallet minimum (except that Client will pay $200 per pallet, per month, one pallet minimum, for any of the Client Property that contains controlled substances, requires refrigeration or other special storage requirements) thereafter for storing the Client Property and will assume any third party storage charges invoiced to Patheon regarding the Client Property. Patheon will invoice Client for the storage charges as set forth in Section 5.5 5.6 of this Agreement. If Client asks Patheon to destroy any Client Property, Client will be responsible for the cost of destruction.
(bf) If The parties will reasonably cooperate to support the transfer of the manufacture of the Products to a Product Agreement is terminated by Client in accordance with Section 8.2(a) because Patheon has delivered Product that does not conform to the Specifications, cGMPs or Applicable Laws, then (i) Section 8.3(a)(i) shall apply but only to the extent that the Product conforms to the Specifications, cGMPs or Applicable Laws, (ii) Section 8.3(a)(iv) shall apply, and (iii) Section 8.4(a)(v) shall apply but only with respect to all Client Property other than Inventory and Materials (but including Client-Supplied Components).
(c) third party manufacturer. Any completion, termination or expiration of this Agreement or a Product Agreement will not affect any outstanding obligations or payments due prior to the completion, termination or expiration, nor will it prejudice any other remedies that the parties may have under this Agreement or a Product Agreement or any related Capital Equipment Agreement. For greater certainty, completion, termination or expiration of this Agreement or of a Product Agreement for any reason will not affect the obligations and responsibilities of the parties under Articles 6, 10, 10 and 11 and 13 and Sections 2.2, 5.4, 5.55.6, 7.3 8.4, 13.1, 13.2, 13.3, and 7.7 and this Section 8.4 and any other provisions of this Agreement which by their terms are expressed to survive any completion, termination or expiration13.16, all of which survive any completion, termination or expirationtermination.
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (Horizon Pharma, Inc.)
Obligations on Termination. (a) If a Product this Agreement is completed, expires, is terminated by Patheon in accordance with Section 8.2(a), (b) or (e), or is terminated by Client in accordance with Section 8.2(c), 8.2(d) or 8.2(f), in whole or in part for any reasonother than breach by Patheon of the warranty provided in Section 9.3(a), then:
(ia) Client will take delivery of and pay for all undelivered Products that are manufactured and/or packaged in accordance with this Agreement under a Firm Order, at the Price price in effect at the time the Firm Order was placed;
(iib) Client will purchase, at Patheon's cost (including all third party costs incurred by Patheon for the purchase and handling of the Inventoryinventory), the Inventory inventory applicable to the Products which was purchased, produced or maintained or produced by Patheon in contemplation of filling Firm Orders or in accordance with Section 5.25.2 prior to notice of termination being given;
(iiic) Client will satisfy the purchase price payable under Patheon's orders with suppliers of Components, if the orders were made by Patheon in reliance on Firm Orders or in accordance with Section 5.2;
(ivd) Client acknowledges that no competitor of Patheon Competitor will be permitted pennltted access to the Manufacturing Site; and.
(ve) Client will make commercially reasonable efforts, at its Its own expense, to remove from Patheon site(s), within [***] days30 Business Days, all unused Active Material and of Client-Supplied 's Components, all applicable Inventory inventory and Materials (whether current or obsolete), supplies, undelivered Product, chattels, equipment or other moveable property owned by Client, related to the Agreement and located at a Patheon site or that is otherwise under Patheon’s 's care and control (“Client Property”'"). If Client fails to remove the Client Property within [***] days five Business Days following the completion, termination, or expiration of the Product Agreement, Agreement Client will pay Patheon [***] $100.00 per pallet, per month, one pallet minimum ($200 per pallet, per month, one pallet minimum, for any of the Client Property that contains controlled substances or requires refrigeration} thereafter for storing the Client Property and will assume any third party storage charges invoiced to Patheon regarding the Client Property. Patheon will invoice Client for the storage charges as set forth in Section 5.5 of this Agreement. If Client asks Patheon to destroy any Client Property, Client will be responsible for the cost of destruction.
(b) If a Product Agreement is terminated by Client in accordance with Section 8.2(a) because Patheon has delivered Product that does not conform to the Specifications, cGMPs or Applicable Laws, then (i) Section 8.3(a)(i) shall apply but only to the extent that the Product conforms to the Specifications, cGMPs or Applicable Laws, (ii) Section 8.3(a)(iv) shall apply, and (iii) Section 8.4(a)(v) shall apply but only with respect to all Client Property other than Inventory and Materials (but including Client-Supplied Components).
(cf) Any completion, termination or expiration of this Agreement or a Product Agreement will not affect any outstanding obligations or payments due hereunder prior to the completion, termination or expiration, nor will it prejudice any other remedies that the parties may have under this Agreement or a Product Agreement [or any related Capital Equipment Agreement). For greater certainty, completion, termination or expiration of this Agreement or of a Product Agreement for any reason will not affect the obligations and responsibilities of the parties under Articles 6, 10, 10 and 11 and 13 and Sections 2.2, 5.4, 5.5, 7.3 8.4, 13.1, 13.2, 13.3, and 7.7 and this Section 8.4 and any other provisions of this Agreement which by their terms are expressed to survive any completion, termination or expiration13.15, all of which survive any completion, termination or expirationtermination.
Appears in 1 contract
Obligations on Termination. (a) If a Product this Agreement is completed, expires, is terminated by Patheon in accordance with Section 8.2(a), (b) or (e), or is terminated by Client in accordance with Section 8.2(c), 8.2(d) or 8.2(f), in whole or in part for any reason, then::
(ia) If either Party terminates under Section 8.2, Client’s Minimum [***] Requirement will expire upon delivery of the termination notice and Client will have no obligation to [***];
(b) Client will take delivery of and pay for all undelivered Products that are manufactured and/or or packaged in accordance with this Agreement under a Firm Order, at the Price in effect at the time the Firm Order was placedreleased;
(iic) Client will purchase, at Patheon's cost purchase all Inventory that was purchased (including all third party costs incurred by Patheon or will be purchased under existing unfulfilled orders for the purchase and handling of the InventoryComponents), the Inventory applicable to the Products which was purchased, maintained or produced by Patheon in contemplation of filling Firm Orders or in accordance with Section 5.2, at Patheon's cost (including all documented costs incurred by Patheon for the purchase of the Inventory);
(iiid) Client will satisfy the purchase price payable under Patheon's orders with suppliers of Components, if the orders were made by Patheon in reliance on Firm Orders or in accordance with Section 5.2;
(iv) Client acknowledges that no Patheon Competitor will be permitted access to the Manufacturing Site; and
(v) Client will make commercially reasonable effortsClient, at its own expense, to will remove from Patheon site(s)the Manufacturing Site, within [***] daysdays following the completion, termination, or expiration of this Agreement, all unused Active Material API and Client-Supplied Components, all applicable Inventory and Materials (whether current or obsolete), supplies, undelivered Product, chattels, equipment or other moveable property owned by Client, related to the Agreement Client and located at a Patheon site the Manufacturing Site or that is otherwise under Patheon’s care and control (“Client Property”). If Client fails to remove Client Property within the [***] days following the completion, termination, or expiration of the Product Agreementday period, Client will pay Patheon $[***] per pallet, per month, one pallet minimum (except that Client will pay $[***] per pallet, per month, one pallet minimum, for any of Client Property that contains controlled substances, requires refrigeration or other special storage requirements) after that for storing Client Property and will assume any third party storage charges invoiced to Patheon regarding Client PropertyProperty (which Patheon may incur at its discretion). Patheon may ship Client Property to Client or to an external warehouse at Client’s risk and expense. Patheon will invoice Client for the these storage charges as set forth out in Section 5.5 5.3 of this Agreement. If Client fails to remove Client Property within [***] days following the completion, termination, or expiration of this Agreement, Client will assume all risk of loss or damage to the stored Client Property and it will be Client’s responsibility to have appropriate insurance coverage in place for this risk. If Client asks Patheon to destroy any Client Property, Client will be responsible for the cost of destruction.; and
(be) If a Product Agreement is terminated by Client in accordance with Section 8.2(a) because Patheon has delivered Product that does not conform to the Specifications, cGMPs or Applicable Laws, then (i) Section 8.3(a)(i) shall apply but only to the extent that the Product conforms to the Specifications, cGMPs or Applicable Laws, (ii) Section 8.3(a)(iv) shall apply, and (iii) Section 8.4(a)(v) shall apply but only with respect to all Client Property other than Inventory and Materials (but including Client-Supplied Components).
(c) Any any completion, termination or expiration of this Agreement or a Product Agreement will not affect any prior outstanding obligations or payments due prior to the completion, termination or expiration, nor will it prejudice any other rights or remedies that the parties may have under this Agreement or a Product Agreement or any related Capital Equipment Agreement. For greater certainty, completionCompletion, termination or expiration of this Agreement or of a Product Agreement for any reason will not affect the obligations and responsibilities of the parties under Articles Sections 6, 107, 11 8.3, 9.3, 9.5 and 13 and Sections 2.2, 5.4, 5.5, 7.3 and 7.7 and this Section 8.4 and any other provisions of this Agreement which by their terms are expressed to survive any completion, termination or expiration10 through 13, all of which survive any completion, termination or expiration, as well as any other provisions that are by implication or otherwise intended to survive any completion, termination or expiration. Where Patheon has agreed to provide stability services beyond the final supply of Product, the relevant provisions of this Agreement related to stability services will survive for the agreed duration of those stability services.
Appears in 1 contract
Obligations on Termination. (a) If a Product Agreement is completed, expires, is terminated by Patheon in accordance with Section 8.2(a), (b) or (e), or is terminated by Client in accordance with Section 8.2(c), 8.2(d) or 8.2(f), in whole or in part for any reason, then:
(ia) Client will take delivery of and pay for all undelivered Products that are manufactured and/or or packaged in accordance with this Agreement under a Firm Order, at the Price in effect at the time the Firm Order was placedreleased;
(iib) Client will purchase, at Patheon's cost purchase all Inventory that was purchased (including all third party costs incurred by Patheon or will be purchased under existing unfulfilled orders for the purchase and handling of the InventoryComponents), the Inventory applicable to the Products which was purchased, maintained or produced by Patheon in contemplation of filling Firm Orders or in accordance with Section 5.2, at Patheon's cost (including all costs incurred by Patheon for the purchase, handling, and processing of the Inventory);
(iiic) Client will satisfy the purchase price payable under Patheon's orders with suppliers of Components, if the orders were made by Patheon in reliance on Firm Orders or in accordance with Section 5.2;
(iv) Client acknowledges that no Patheon Competitor will be permitted access to the Manufacturing Site; and
(v) Client will make commercially reasonable effortsClient, at its own expense, to will remove from Patheon site(s)the Manufacturing Site, within [***] days30 days following the completion, termination, or expiration of the Product Agreement, all unused Active Material API and Client-Supplied Components, all applicable Inventory and Materials (whether current or obsolete), supplies, undelivered Product, chattels, equipment or other moveable property owned by Client, related to the Agreement and located at a Patheon site the Manufacturing Site or that is otherwise under Patheon’s care and control (“Client Property”). If Client fails to remove Client Property within [***] days following the completion, termination, or expiration of the Product Agreement30 day period, Client will pay Patheon [***] per pallet, per month, one pallet minimum (except that Client will pay [***] per pallet, per month, one pallet minimum, for any of Client Property that contains controlled substances, requires refrigeration or other special storage requirements) after that for storing Client Property and will assume any third party storage charges invoiced to Patheon regarding Client PropertyProperty (which Patheon may incur at its discretion). Patheon may ship Client Property to Client or to an external warehouse at Client’s risk and expense. Patheon will invoice Client for the these storage charges as set forth out in Section 5.5 5.3 of this Agreement. If Client fails to remove Client Property within 30 days following the completion, termination, or expiration of the Product Agreement, Client will assume all risk of loss or damage to the stored Client Property and it will be Client’s responsibility to have appropriate insurance coverage in place for this risk. If Client asks Patheon to destroy any Client Property, Client will be responsible for the cost of destruction.; and
(bd) If a Product Agreement is terminated by Client in accordance with Section 8.2(a) because Patheon has delivered Product that does not conform to the Specifications, cGMPs or Applicable Laws, then (i) Section 8.3(a)(i) shall apply but only to the extent that the Product conforms to the Specifications, cGMPs or Applicable Laws, (ii) Section 8.3(a)(iv) shall apply, and (iii) Section 8.4(a)(v) shall apply but only with respect to all Client Property other than Inventory and Materials (but including Client-Supplied Components).
(c) Any any completion, termination or expiration of this Agreement or a Product Agreement will not affect any prior outstanding obligations or payments due prior to the completion, termination or expiration, nor will it prejudice any other remedies that the parties may have under this Agreement or a Product Agreement or any related Capital Equipment Agreement. For greater certainty, completionCompletion, termination or expiration of this Agreement or of a Product Agreement for any reason will not affect the obligations and responsibilities of the parties under Articles 6Sections 5.1(e), 10, 11 and 13 and Sections 2.25.1(f), 5.4, 5.5, 7.3 8.3, 10, 11, 12, 13.14, 13.15 and 7.7 and this Section 8.4 and any other provisions of this Agreement which by their terms are expressed to survive any completion, termination or expiration13.16, all of which survive any completion, termination or expiration, as well as any other provisions that are by implication or otherwise intended to survive any completion, termination or expiration. Where Patheon has agreed to provide stability services beyond the final supply of Product, the relevant provisions of this Agreement will survive for the agreed duration of those stability services.
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (Savara Inc)
Obligations on Termination. (a) If a Product this Agreement is completed, expires, is terminated by Patheon in accordance with Section 8.2(a), (b) or (e), or is terminated by Client in accordance with Section 8.2(c), 8.2(d) or 8.2(f), in whole or in part for any reason, then:
(ia) Client will take delivery of and pay for all undelivered Products that are manufactured and/or packaged in accordance with this Agreement under a Firm Order, at the Price price in effect at the time the Firm Order was placed;
(iib) Client will purchase, at Patheon's cost (including all third party costs incurred by Patheon for the purchase and handling of the InventoryInventory including a ***% handling fee), the Inventory applicable to the Products which was purchased, produced or maintained or produced by Patheon in contemplation of filling Firm Orders or in accordance with Section 5.25.2 prior to notice of termination being given;
(iiic) Client will satisfy the purchase price payable under Patheon's orders with suppliers of Components, if the orders were made by Patheon in reliance on Firm Orders or in accordance with Section 5.25.2 and which are not currently usable by Patheon to manufacture products for third parties or cannot be returned to suppliers for a full or partial refund;
(ivd) Patheon will return to Client all unused Active Materials (with shipping and related expenses, if any, to be borne by Client);
(e) Client acknowledges that no competitor of Patheon Competitor will be permitted access to the Manufacturing Site; and
(vf) Client will make commercially reasonable efforts, at its own expense, to remove from Patheon site(s), within [***] 30 days, all unused Active Material and of Client-Supplied ’s Components, all applicable Inventory and Materials (whether current or obsolete), supplies, undelivered Product, chattels, equipment Equipment or other moveable property owned by Client, related to the Agreement and located at a Patheon site Manufacturing Site or that is otherwise under Patheon’s care and control (“Client Property”). If Client fails to remove the Client Property within [***] 30 days following the completion, termination, or expiration of the Product Agreement, Agreement Client will pay Patheon [$*** per pallet, per ***] , one pallet minimum ($*** per pallet, per ***, one pallet minimum, for any of the Client Property that contains controlled substances or requires refrigeration) thereafter for storing the Client Property and will assume any third party storage charges invoiced to Patheon regarding the Client Property. Patheon will invoice Client for the storage charges as set forth in Section 5.5 5.6 of this Agreement. If Client asks Patheon to destroy any Client Property, Client will be responsible for the cost of destruction.
(b) If a Product Agreement is terminated by Client in accordance with Section 8.2(a) because Patheon has delivered Product that does not conform to the Specifications, cGMPs or Applicable Laws, then (i) Section 8.3(a)(i) shall apply but only to the extent that the Product conforms to the Specifications, cGMPs or Applicable Laws, (ii) Section 8.3(a)(iv) shall apply, and (iii) Section 8.4(a)(v) shall apply but only with respect to all Client Property other than Inventory and Materials (but including Client-Supplied Components).
(c) Any completion, termination or expiration of this Agreement or a Product Agreement will not affect any outstanding obligations or payments due hereunder prior to the completion, termination or expiration, nor will it prejudice any other remedies that the parties may have under this Agreement or a Product Agreement or any related the Capital Expenditure and Equipment Agreement. For greater certainty, completion, termination or expiration of this Agreement or of a Product Agreement for any reason will not affect the obligations and responsibilities of the parties under Articles 6, 10, 10 and 11 and 13 and Sections 2.2, 5.4, 5.55.6, 7.3 8.4, 13.1, 13.2, 13.3, and 7.7 and this Section 8.4 and any other provisions of this Agreement which by their terms are expressed to survive any completion, termination or expiration13.15, all of which survive any completion, termination or expirationtermination.
Appears in 1 contract
Obligations on Termination. (a) If a Product this Agreement is completed, expires, is terminated by Patheon in accordance with Section 8.2(a), (b) or (e), expires or is terminated by Client in accordance with Section 8.2(c), 8.2(d) or 8.2(f), in whole or in part for any reason, then:then following the expiration or termination of this Agreement, or the end of the Wind-Down Period, if applicable (in addition to any other remedies either party may have in the event of default by the other party):
(ia) the Client will shall take delivery of and pay for (in accordance with Section 5.6) all undelivered Products that are manufactured and/or packaged in accordance with this Agreement under pursuant to a Firm Order, at the Price price in effect at the time the Firm Order was placed;.
(iib) the Client will shall purchase, at Patheon's ’s cost ****, (including all third party costs incurred by Patheon for i) the purchase and handling of the Inventory), the Inventory remaining Components applicable to the Products which was purchased, maintained or produced were purchased by Patheon in contemplation of filling Firm Orders or in accordance with Section 5.2;
5.2 prior to notice of termination being given to the extent that such Components cannot be returned or used to produce product for another client; and (iiiii) Client will satisfy the purchase price payable under Patheon's orders with suppliers of Components, if the orders were made all remaining work-in-process produced by Patheon in reliance on contemplation of filling Firm Orders or in accordance with Section 5.2;prior to notice of termination being given.
(ivc) the Client acknowledges that no competitor of Patheon Competitor will (as defined in Section 8.2(d)) shall be permitted access to the Manufacturing Site; and. ****CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
(vd) Client will make commercially reasonable efforts, at its own expenseexpense but with Patheon’s reasonable cooperation, to remove from Patheon site(s), within [***] days*, all unused Active Material and of Client-Supplied ’s Components, all applicable Inventory and Materials (whether current or obsolete), supplies, undelivered Product, chattels, equipment or other moveable property owned by Client, related to the Agreement and located at a Patheon site or that is otherwise under Patheon’s care and control (“Client Property”). If Client fails to remove the Client Property within [***] days * following the completion, termination, termination or expiration of the Product AgreementAgreement (or following the end of the Wind-Down Period, if applicable), Client will pay Patheon [***] * per pallet, per month, one pallet minimum (**** per pallet, per month, one pallet minimum, for any of the Client Property that contains controlled substances or requires refrigeration) thereafter for storing the Client Property and will assume any third party storage charges invoiced to Patheon regarding the Client Property. Patheon will invoice Client for the storage charges as set forth in Section 5.5 5.6 of this Agreement. If Client asks Patheon to destroy any Client Property, Client will be responsible for the cost of destruction.
(b) If a Product this Agreement expires or is terminated by Client in accordance with Section 8.2(a) because Patheon has delivered Product that does not conform to the Specifications, cGMPs whole or Applicable Lawsin part for any reason, then (i) Section 8.3(a)(i) in addition to any other remedies the Client may have in the event of default by Patheon), Patheon shall apply but only return to the extent that the Product conforms Client promptly all unused Active Materials and provide to the SpecificationsClient all Inventory purchased by the Client (with shipping and related expenses, cGMPs if any, to be borne by the Client), following such expiration or Applicable Lawstermination or the end of the Wind-Down Period, (ii) Section 8.3(a)(iv) shall applyif applicable. In addition, and (iii) Section 8.4(a)(v) shall apply but only with respect to all Client Property other than Inventory and Materials (but including Client-Supplied Components).
(c) Any completion, for a period of **** after the termination or expiration of this Agreement (the “Wind-Down Period”), Client may continue to order Manufacturing, and Patheon shall continue to provide Manufacturing in accordance with such orders from Client (if any), in each case subject to the terms and conditions of this Agreement. In the event of termination by Patheon pursuant to Section 8.2(a) due to Client’s failure to pay undisputed amounts, Patheon may require that Client pay such amounts before filling any Firm Orders and may require that Client pre-pay for any Manufacturing Services provided during the Wind-Down Period. Furthermore, upon reasonable request by Client, Patheon will use commercially reasonable and good faith efforts to discuss with Client and come to an agreement with Client with respect to the terms for the performance of other transition services that are reasonably requested by Client. Any termination or a Product expiration of this Agreement will shall not affect any outstanding obligations or payments due hereunder prior to the completion, such termination or expiration, nor will shall it prejudice any other remedies that the parties may have under this Agreement or a Product Agreement or any related Capital Equipment Agreement. For greater certainty, completion, termination or expiration of this Agreement or of a Product Agreement for any reason will shall not affect the obligations and responsibilities of the parties under pursuant to Articles 6, 8, 9, 10, 11 11, 12 and 13 and Sections 2.21.1, 5.47.3, 5.57.4, 7.3 7.5, 7.6 and 7.7 and this Section 8.4 and any other provisions of this Agreement which by their terms are expressed to survive any completion, termination or expiration7.7, all of which survive any completion, termination or expirationtermination. ****CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Appears in 1 contract
Samples: Manufacturing Agreement (Vanda Pharmaceuticals Inc.)
Obligations on Termination. (a) If a Product this Agreement is completed, expires, is terminated by Patheon in accordance with Section 8.2(a), (b) or (e), or is terminated by Client in accordance with Section 8.2(c), 8.2(d) or 8.2(f), in whole or in part for any reasonreason (other than by Client pursuant to Section 8.2), then:
(ia) Client will take delivery of and pay for all undelivered conforming Products that are manufactured and/or packaged in accordance with this Agreement under a Firm Order, at the Price in effect at the time the Firm Order was placed;.
(iib) Client will purchase, at Patheon's ’s actual cost (including all third party costs incurred by Patheon for the purchase and handling of the Inventory), the Inventory applicable to the Products which was purchased, produced and maintained or produced by Patheon in contemplation of filling Firm Orders or in accordance with Section 5.2;.
(iiic) Client will satisfy reimburse Patheon the purchase price payable actually paid by Patheon under Patheon's ’s non-cancellable orders with suppliers of Components, if the orders were made by Patheon in reliance on Firm Orders or in accordance with Section 5.2;
; and Patheon will, at Client’s option, either return to Client all unused Active Materials (ivwith shipping and related expenses, if any, to be borne by Client) or destroy all unused Active Materials in accordance with Client’s directions and at Client’s expense; and Client acknowledges that no contract manufacturer that is a direct competitor of Patheon Competitor will be permitted access to the Manufacturing Site; andSite unless otherwise agreed in writing by the parties.
(vd) Client will make commercially reasonable efforts, at its own expense, to remove from Patheon site(s), within [***] days30 Business Days, all unused Active Material and of Client-Supplied ’s Components, all applicable Inventory and Active Materials (whether current or obsolete), supplies, undelivered Product, chattels, equipment or other moveable property owned by Client, related to the Agreement and located at a Patheon site or that is otherwise under Patheon’s care and control (“Client Property”). If Client fails to remove the Client Property within [***] days 30 Business Days following the completion, termination, or expiration of the Product Agreement, Agreement Client will pay Patheon $[…***…] per pallet, per month, one pallet minimum ($[…***…] per pallet, per month, one pallet minimum, for any of the Client Property that contains controlled substances or requires refrigeration) thereafter for storing the Client Property and will assume any reasonable, documented third party storage charges invoiced to Patheon regarding the Client Property. Patheon will invoice Client for the storage charges as set forth in Section 5.5 5.6 of this Agreement. If In addition, upon any expiration or termination of this Agreement, Patheon will immediately cease all Manufacturing Services (unless otherwise instructed by Client) and return to Client asks Patheon to destroy any Client Propertyall Confidential Information, Client will be responsible for the cost of destruction.
(b) If a Product Agreement is terminated by Client in accordance with Section 8.2(a) because Patheon has delivered Product that does not conform to the Specificationsunused Active Materials, cGMPs or Applicable Laws, then (i) Section 8.3(a)(i) shall apply but only to the extent that the Product conforms to the Specifications, cGMPs or Applicable Laws, (ii) Section 8.3(a)(iv) shall apply, and (iii) Section 8.4(a)(v) shall apply but only with respect to all Client Property other than Inventory and Materials (but including Client-Supplied Componentssupplied Components and Xxxx Back Items (with reasonable shipping and related expenses, if any, to be borne by Client).
(c) . Any completion, termination or expiration of this Agreement or a Product Agreement will not affect any outstanding obligations or payments due hereunder prior to the completion, termination or expiration, nor will it prejudice any other remedies that the parties may have under this Agreement or a Product Agreement or any related Capital Equipment Agreement. For greater certainty, completion, expiration or termination or expiration of this Agreement or of a Product Agreement for any reason will not affect the obligations and responsibilities of the parties under Articles 6, 10, 11 and 13 12 and Sections 2.2, 5.4, 5.55.5(a), 7.3 5.6, 7.3, 7.4, 8.5, 13.1, 13.2, 13.3, 13.11, 13.15 and 7.7 and this Section 8.4 and any other provisions of this Agreement which by their terms are expressed to survive any completion, termination or expiration13.16, all of which survive any completion, termination expiration or expirationtermination.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Optimer Pharmaceuticals Inc)
Obligations on Termination. (a) If a Product Agreement is completed, expires, is terminated by Patheon in accordance with Section 8.2(a), (b) or (e), or is terminated by Client in accordance with Section 8.2(c), 8.2(d) or 8.2(f), in whole or in part for any reason, then:
(i) Patheon will Manufacture and supply and Client will take delivery Delivery of and pay for all undelivered unDelivered Products that are manufactured Manufactured and/or packaged in accordance with this Agreement under a Firm Order, at the Price in effect at the time the Firm Order was placed;
(ii) Client will purchase, at Patheon's ’s cost (including all third party costs incurred by Patheon for the purchase purchase, handling, and handling processing of the Inventory), the Inventory applicable to the Products which was purchased, maintained or produced by Patheon in contemplation of filling Firm Orders or in accordance with Section 5.2;
(iii) Client will satisfy the purchase price payable any write-off costs (in accordance with IFRS) that Patheon actually incurs under Patheon's ’s orders with suppliers of Components, if the orders were made by Patheon in reliance on Firm Orders or in accordance with Section 5.25.2 and cannot be cancelled;
(iv) Client acknowledges that no Patheon Competitor will be permitted access to the Manufacturing Site;
(v) after expiry or termination of this Agreement, the parties shall provide each other with reasonable support with respect to any investigation carried out by a Regulatory Authority with respect to the Manufacture of any Product under this Agreement, provided that the reasonable costs of the assisting party in providing such assistance shall be reimbursed by the party requesting such assistance; and
(vvi) Client will make commercially reasonable effortsCommercially Reasonable Endeavours, at its own expense, to remove from Patheon site(s), within [***] 30 days, all unused Active Material and Client-Supplied Components, all applicable Inventory and Materials (whether current or obsolete), supplies, undelivered unDelivered Product, chattels, equipment or other moveable property owned by Client, related to the Agreement and located at a Patheon site or that is otherwise under Patheon’s care and control (“Client Property”). Patheon will cooperate in good faith with Client in this regard, providing sufficient access rights and support as is reasonably required by the Client. If Client fails to remove Client Property within [***] 30 days following the completion, termination, or expiration of the Product Agreement, Client will pay Patheon [***] EURO 150 per pallet, per month, one pallet minimum (except that Client will pay EURO 300 per pallet, per month, one pallet minimum, for any of Client Property that contains controlled substances, requires refrigeration or other special storage requirements) thereafter for storing Client Property and will assume any third party storage charges invoiced to Patheon regarding Client Property. Patheon will invoice Client for the storage charges as set forth in Section 5.5 of this Agreement. If Client fails to remove Client Property within 30 days following the completion, termination, or expiration of the Product Agreement, Client will assume all risk of loss or damage to the stored Client Property and it will be Client’s responsibility to have appropriate insurance coverage in place for this risk. If Client asks Patheon to destroy any Client Property, Client will be responsible for the cost of destruction.
(b) If Client may,
(i) at any time during the Term (in respect of the transfer of Manufacturing Services to another Manufacturing Site owned or occupied by Patheon or an Affiliate of Patheon); or
(ii) in the event of expiration or termination of this Agreement, at any time during the Term following notice of termination or within ninety (90) days of termination or expiration (in respect of the transfer of all Manufacturing Services and associated activities to a Product Agreement is terminated third party), in each case except for termination by Patheon pursuant to Section 8.2(a), (b) or (e), or for termination by Client pursuant to Section 8.2(c) or (d) (in relation to the applicable Product), on a Product-by-Product basis, request from Patheon, and, upon terms and conditions agreed with Patheon (with each party acting promptly, reasonably and in good faith), Patheon shall, provide or cause to be provided, technical transfer services to support a smooth and efficient transfer of the Manufacturing Services in respect of any Product or Component thereof from Patheon, its Affiliate(s) and/or subcontractor(s) to Client, or its designee(s) (including an Affiliate of Patheon in respect of a transfer of Manufacturing Site) in accordance with Applicable Laws and any regulatory requirements arising from, or connected to, such technical transfer services. Provided that in agreeing the terms and conditions of the provision of technical transfer services it shall be assumed that:
(iii) in the event of a technical transfer request (i) following or directly arising from a termination of the Agreement or the relevant Product Agreement pursuant to Section 8.2(a) because or 8.2(b) by Client Patheon has delivered Product that does not conform shall (at its cost) provide support to the Specificationstechnology transfer (which shall, cGMPs or Applicable Lawswithout limitation, then (iinclude the provision of such suitably qualified personnel, technical support information) Section 8.3(a)(i) shall apply but only relating to the extent that Manufacturing process and development, as is reasonably required to ensure the smooth and efficient transfer of the production of the Manufacturing of the Products within a reasonable period, including the provision of all necessary documentation); and
(iv) in all other cases the costs of the technical transfer shall be allocated in accordance with the cost allocation principles set out in the Product conforms to the Specifications, cGMPs or Applicable Laws, (ii) Section 8.3(a)(iv) shall apply, and (iii) Section 8.4(a)(v) shall apply but only with respect to all Client Property other than Inventory and Materials (but including Client-Supplied Components)Agreement.
(c) Any completion, termination or expiration of this Agreement or a Product Agreement will not affect any outstanding obligations or payments due prior to the completion, termination or expiration, nor will it prejudice any other remedies that the parties may have under this Agreement or a Product Agreement or any related Capital Equipment Agreement. For greater certainty, completion, termination or expiration of this Agreement or of a Product Agreement for any reason will not affect the obligations and responsibilities of the parties under Articles 6, 10, 10 and 11 and 13 and Sections 2.2, 5.4, 5.5, 7.3 6, 7.3, 8.3, 13.1, 13.2, 13.3, 13.11, 13.16 and 7.7 13.19 and this Section 8.4 and the continuation in force of any other provisions of this Agreement which by their terms are expressed to survive any completion, termination or expirationnecessary for interpretation purposes, all of which survive any completion, termination or expiration.
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (Melinta Therapeutics, Inc. /New/)
Obligations on Termination. (a) If a Product Agreement is completed, expires, is terminated by Patheon in accordance with Section 8.2(a), (b) or (e), or is terminated by Client in accordance with Section 8.2(c), 8.2(d) or 8.2(f), in whole or in part for any reason, then:
(ia) Client will take delivery of and pay for all undelivered Products Product that are was manufactured and/or packaged in accordance compliance with the Product Agreement and this Agreement under a Firm Order, Order at the Price price in effect at the time the Firm Order was placed;
(iib) Client will purchase, at Patheon's cost (including all third party costs incurred by Patheon plus a [*] handling fee for the purchase and handling of the InventoryComponents), the Inventory applicable to the Products which was purchased, produced or maintained or produced by Patheon in contemplation of filling reliance on Firm Orders or in accordance with Section 5.25.2 prior to notice of termination being given;
(iiic) Client will satisfy the purchase price payable under Patheon's orders with suppliers of Components, if the orders were made by Patheon in reliance on Firm Orders or in accordance with Section 5.2;
(ivd) Patheon will return to Client all unused Active Materials (with shipping and related expenses, if any, to be borne by Client).
(e) Client acknowledges that no Patheon Competitor will be permitted access to the Manufacturing Site; and
(vf) Client will make commercially reasonable efforts, at its own expense, to remove from Patheon site(s), within [***] days, all unused Active Material and Client-Supplied Components, all applicable Inventory and Materials (whether current or obsolete), supplies, undelivered Product, chattels, equipment or other moveable property owned by Client, related to the Agreement and located at a Patheon site or that is otherwise under Patheon’s care and control (“Client Property”). If Client fails to remove the Client Property within [***] days following the completion, termination, or expiration of the Product Agreement, Client will pay Patheon [**] per pallet, per month, [*] minimum (except that Client will pay [*] per pallet, per month, [*] minimum, for any of the Client Property that contains controlled substances, requires refrigeration or other special storage requirements) thereafter for storing the Client Property and will assume any third party storage charges invoiced to Patheon regarding the Client Property. Patheon will invoice Client for the storage charges as set forth in Section 5.5 of this Agreement.
(g) In connection with the expiration or termination of this Agreement or any Product Agreement hereunder, at Client’s request, Patheon will provide assistance reasonably required to transfer the Manufacturing Services. If Such assistance may include, without limitation, providing documents required for the Manufacturing Services, attending meetings (in person or via teleconference), and subject to the confidentiality provisions hereof, hosting a Manufacturing Site visit. Except in cases of termination by Client asks Patheon pursuant to destroy any Client PropertySection 8.2, Client will be responsible reimburse Patheon for its costs incurred in providing [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the cost Securities and Exchange Commission pursuant to Rule 24b-2 of destruction.
(b) If a Product Agreement is terminated by Client the Securities Exchange Act of 1934, as amended. such assistance in accordance with Section 8.2(a) because Patheon has delivered Product that does not conform to a tech transfer plan and budget negotiated in good faith and agreed upon by the Specifications, cGMPs or Applicable Laws, then (i) Section 8.3(a)(i) shall apply but only to the extent that the Product conforms to the Specifications, cGMPs or Applicable Laws, (ii) Section 8.3(a)(iv) shall apply, and (iii) Section 8.4(a)(v) shall apply but only with respect to all Client Property other than Inventory and Materials (but including Client-Supplied Components).
(c) Any completionparties. Any, termination or expiration of this Agreement or a Product Agreement will not affect any outstanding obligations or payments due prior to the completion, termination or expiration, nor will it prejudice any other remedies that the parties may have under this Agreement or a Product Agreement or any related Capital Equipment Agreement. For greater certainty, completion, the termination or expiration of this Agreement or of a Product Agreement for any reason will not affect the obligations and responsibilities of the parties under Articles 69, 10, 10 and 11 and 13 and Sections 2.2, 5.4, 5.5, 7.3 8.5, 13.1, 13.2 and 7.7 and this Section 8.4 and any other provisions of this Agreement which by their terms are expressed to survive any completion, termination or expiration13.3, all of which survive any completion, termination or expiration.
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (Jazz Pharmaceuticals PLC)