Common use of Supply of Products Clause in Contracts

Supply of Products. (a) Cipher shall cause its Approved Manufacturer and Contract Finisher to Package the Product for Distributor. Distributor shall purchase from Cipher all of Distributor’s requirements for the Product in the Territory during the Term, pursuant to purchase orders submitted by Distributor or its affiliates to Cipher from time to time in accordance with Section 6.2. (b) Cipher shall supply all Product under this Agreement to Distributor in the agreed upon dosage strengths, labelled package sizes and minimum batch requirements in accordance with the terms and conditions of this Agreement (including Schedule B and Schedule E). Cipher shall exercise Commercially Reasonable Efforts to deliver Product to Distributor that has a shelf life and expiration date of at least [***] (but in no event less than [***]) at the date of shipment (it being understood that the failure to have [***] shelf life is not a reason for a Rejection Notice pursuant to Section 6.7). (c) Cipher and its Approved Manufacturer and its Contract Finisher shall be responsible for the purchase of adequate supplies of all materials, including raw materials, in accordance with the NDA and other filings with Regulatory Authorities for the Product as necessary to supply finished Product to Distributor in accordance to the Specifications and applicable Law. (d) The Product shall be manufactured with Packaging as specified by Distributor acting reasonably, including (i) identifying Cipher’s Approved Manufacturer as the manufacturer of the Products and Distributor as the distributor thereof, (ii) bearing Distributor’s National Drug Code number, and (iii) including appropriate trademark notices. Within five (5) business days after the Effective Date, Distributor shall, at its sole cost and expense, provide Cipher with final specifications for such Packaging for the Products, including all necessary photo-ready artwork (or its substantial equivalent). Distributor, from time to time but not more than one (1) time per year, may update the Packaging specifications. Such updates shall be subject to the prior written approval of Cipher. Distributor shall, at Distributor’s expense, use Commercially Reasonable Efforts to secure any approvals required by the FDA or any other applicable Regulatory Authority to effect such revisions to the Packaging. (e) All costs associated with initial packaging setup incurred by the Contract Finisher will be paid by Cipher and, promptly upon Cipher’s invoice with supporting detail, Distributor shall reimburse Cipher for [***] of such costs, provided that such [***] shall in no event exceed [***]. (f) The terms and conditions of this Agreement shall control the Manufacture and supply of Product by Cipher to Distributor, and no terms or conditions contained in any purchase order, acknowledgment, invoice, xxxx of lading, acceptance or other pre-printed form issued by any Party shall have any force or effect to the extent they are inconsistent with or modify the terms and conditions of this Agreement including those set forth in this Section 6.1, unless mutually agreed in writing by the Parties. (g) Out-of-pocket costs associated with regulatory changes requested by (i) the Regulatory Authority which cause finished product, raw materials, labelling and other materials to be discarded will be borne [***] by Distributor and [***] by Cipher, and (ii) Distributor which cause product, raw materials, labelling and other materials to be discarded will be borne one hundred percent (100%) by Distributor. (h) The costs of implementing chemistry, manufacturing and control changes or ancillary additional Testing not included in the original NDA that is either requested by Distributor or a Regulatory Authority after the First Commercial Sale shall be borne one hundred percent (100%) by Distributor if requested by Distributor and [***] by Distributor and [***] by Cipher if requested by a Regulatory Authority.

Supply of Products. (a) Cipher shall cause its Approved Manufacturer If the Continuing Licensee is not supplying any of the applicable Product or Products under this Agreement, it may either require the other party to continue to supply the applicable Product or Products, upon the terms and Contract Finisher to Package the Product for Distributor. Distributor shall purchase from Cipher all of Distributor’s requirements for the period described below, or cause the other party to transfer the required technology to the Continuing Licensee. If a Continuing Licensee elects to require the other party to continue to supply Products, it shall pay the supplying party, on a quarterly basis, an amount equal to [CONFIDENTIAL TREATMENT REQUESTED] for all Products continued to be supplied hereunder. The supplying party shall only be obligated to supply Products for a reasonable transition period, which period shall not exceed [CONFIDENTIAL TREATMENT REQUESTED] from the date that the Collaborator elects to become a Continuing Licensee. The Continuing Licensee shall use all commercially reasonable efforts to identify a replacement manufacturer or establish a manufacturing facility for the Products in a timely manner. The supplying party shall take such steps as are reasonably required to enable the Continuing Licensee to assume the business of producing the Products. If for any reason the supplying party is not legally permitted to transfer the necessary technology or rights to the Continuing Licensee for these purposes, the supplying party will continue to provide the applicable Product in or Products under this Agreement or to otherwise make available to the Territory during Continuing Licensee the Termbenefits of this Section 16.4, pursuant to purchase orders submitted commercially reasonable terms to be mutually agreed upon by Distributor or its affiliates to Cipher from time to time in accordance with Section 6.2. (b) Cipher shall the parties. Any amounts owed by the Continuing Licensee for Product supply all Product under this Agreement to Distributor in shall be set off against the agreed upon dosage strengthsamount, labelled package sizes and minimum batch requirements in accordance with if any, of unbalanced Allowable Expenses of the terms and conditions Continuing Licensee existing as of the effective termination date of this Agreement Agreement. If a Continuing Licensee elects to cause a transfer of the required technology to manufacture Products, the transferring party shall take such steps as are reasonably required to enable the Continuing Licensee to manufacture (including Schedule B and Schedule E). Cipher shall exercise Commercially Reasonable Efforts to deliver Product to Distributor that has a shelf life and expiration date of at least [***] (but in no event less than [***]or have manufactured) at the date of shipment (it being understood that the failure to have [***] shelf life is not a reason for a Rejection Notice pursuant to Section 6.7). (c) Cipher and its Approved Manufacturer and its Contract Finisher shall be responsible for the purchase of adequate supplies of all materialsProducts, including raw materialsincluding, in accordance with the NDA and other filings with Regulatory Authorities for the Product as necessary to supply finished Product to Distributor in accordance without limitation, by providing to the Specifications Continuing Licensee: (x) all manufacturing information and descriptions of the applicable Law. (d) The Product shall be manufactured with Packaging as specified by Distributor acting reasonably, including (i) identifying Cipher’s Approved Manufacturer as technology and processes in sufficient detail to permit the manufacturer manufacture of the Products and Distributor as the distributor thereof, in commercial quantities in an efficient manner; (iiy) bearing Distributor’s National Drug Code number, samples of all organisms or other biological material used in producing such Products; and (iiiz) including appropriate trademark notices. Within five (5) business days after training of personnel as may be necessary to permit the Effective Date, Distributor shall, at its sole cost and expense, provide Cipher with final specifications for such Packaging for manufacture of the Products. The Continuing Licensee shall pay the transferring party a royalty on sales of Products at a rate to be negotiated by the parties in good faith at the time of such license, including all necessary photo-ready artwork (or its substantial equivalent). Distributor, from time to time but shall not be more than one (1) time per year, may update the Packaging specifications. Such updates shall be subject to the prior written approval of Cipher. Distributor shall, at Distributor’s expense, use Commercially Reasonable Efforts to secure any approvals required by the FDA or any other applicable Regulatory Authority to effect such revisions to the Packaging. (e) All costs associated with initial packaging setup incurred by the Contract Finisher will be paid by Cipher and, promptly upon Cipher’s invoice with supporting detail, Distributor shall reimburse Cipher for [***CONFIDENTIAL TREATMENT REQUESTED] of such costs, provided that such [***] shall in no event exceed [***]the royalties payable by Chiron under Article 8 hereof. (f) The terms and conditions of this Agreement shall control the Manufacture and supply of Product by Cipher to Distributor, and no terms or conditions contained in any purchase order, acknowledgment, invoice, xxxx of lading, acceptance or other pre-printed form issued by any Party shall have any force or effect to the extent they are inconsistent with or modify the terms and conditions of this Agreement including those set forth in this Section 6.1, unless mutually agreed in writing by the Parties. (g) Out-of-pocket costs associated with regulatory changes requested by (i) the Regulatory Authority which cause finished product, raw materials, labelling and other materials to be discarded will be borne [***] by Distributor and [***] by Cipher, and (ii) Distributor which cause product, raw materials, labelling and other materials to be discarded will be borne one hundred percent (100%) by Distributor. (h) The costs of implementing chemistry, manufacturing and control changes or ancillary additional Testing not included in the original NDA that is either requested by Distributor or a Regulatory Authority after the First Commercial Sale shall be borne one hundred percent (100%) by Distributor if requested by Distributor and [***] by Distributor and [***] by Cipher if requested by a Regulatory Authority.

Supply of Products. (a) Cipher Vertical shall cause its the Approved Manufacturer and Contract Finisher to Manufacture and Package the Product for Sub-Distributor, and Vertical shall supply the Product to Sub-Distributor, in accordance with the terms and conditions hereof. Subject to the terms and conditions hereof (including timely supply of Product), Sub-Distributor shall purchase from Cipher Vertical all of Sub-Distributor’s requirements for the Product in the Territory Market during the Term, pursuant to purchase orders submitted by Sub-Distributor or its affiliates Affiliates to Cipher Vertical from time to time in accordance with Section 6.24.2. (b) Cipher Vertical shall supply all Product under this Agreement to Distributor in the agreed upon dosage strengthsSub-Distributor, labelled labeled package sizes and minimum batch requirements in accordance with the terms and conditions of this Agreement (including Schedule B and Schedule E). Cipher shall exercise Commercially Reasonable Efforts to deliver Product to Distributor that has a shelf life and expiration date of at least [***] (but in no event less than [***]) at the date of shipment (it being understood that the failure to have [***] shelf life is not a reason for a Rejection Notice pursuant to Section 6.7)Agreement. (c) Vertical, Cipher and its the Approved Manufacturer and its and/or Contract Finisher shall be responsible (and Vertical shall ensure the performance of Cipher and the Approved Manufacturer and/or Contract Finisher of the same) for the purchase of adequate supplies of all materials, including raw materials, in accordance with the Product NDA and other filings with Regulatory Authorities for the Product as necessary to Manufacture, Test, Package and supply finished Product to Sub-Distributor in accordance to with the Specifications Specifications, Applicable Law and applicable Law. (d) the terms and conditions of this Agreement. The Product shall be manufactured with Packaging as specified in the Product NDA and as required by Distributor acting reasonablyApplicable Law, including (i) identifying Cipher’s the Approved Manufacturer as the manufacturer of the Products and Sub-Distributor as the distributor thereof, (ii) bearing Sub-Distributor’s National Drug Drag Code number, and (iii) including appropriate trademark notices. Within five (5) business days after the Effective Date, Distributor shall, at its sole cost and expense, provide Cipher with final specifications for such Packaging for the Products, including all necessary photo-ready artwork (or its substantial equivalent). Distributor, from time to time but not more than one (1) time per year, may update the Packaging specifications. Such updates shall be subject to the prior written approval of Cipher. Distributor shall, at Distributor’s expense, use Commercially Reasonable Efforts to secure any approvals required by the FDA or any other applicable Regulatory Authority to effect such revisions to the Packaging. (e) All costs associated with initial packaging setup incurred by the Contract Finisher will be paid by Cipher and, promptly upon Cipher’s invoice with supporting detail, Distributor shall reimburse Cipher for [***] of such costs, provided that such [***] shall in no event exceed [***]. (fd) The terms and conditions of this Agreement shall control the Manufacture and supply of Product by Cipher Vertical to Sub-Distributor, and no terms or conditions contained in any purchase order, acknowledgment, invoice, xxxx of lading, acceptance or other pre-printed preprinted form issued by any Party shall have any force or effect to the extent they are inconsistent with or modify the terms and conditions of this Agreement including those set forth in this Section 6.14.1, unless mutually agreed in writing by the Parties. (ge) The Specifications for the Product are as described in the NDA for the Product. The Specifications for the Product shall not be changed except as expressly permitted under this Agreement. (i) With respect to any changes to the Specifications or to any process involved in the Manufacture, Packaging, Labeling, storage, transportation, delivery or Testing of the Product that are required by Applicable Laws or by mandate of an applicable Regulatory Authority (including, but not limited to the FDA), the Parties shall reasonably cooperate in making such changes promptly, and Vertical and Sub-Distributor shall each bear [***] of the costs of implementing such changes, including the cost of scrapping materials (including raw materials, in-process materials, inventory and packaging material) associated with such changes. (ii) With respect to changes to the Specifications or to any process involved in the Manufacture, Packaging, Labeling, storage, transportation, delivery or Testing of the Product that are not required by Applicable Laws or by mandate of an applicable Regulatory Authority (including, but not limited to the FDA), the Parties shall cooperate in good faith to reach a mutually agreeable solution with regard to such changes. The cost of making a discretionary change shall be borne, as between Vertical and Sub-Distributor, solely by the Party initiating the change or as otherwise mutually agreed to in writing by the Parties. Vertical shall be responsible, at its expense, for ensuring the Contract Manufacturer conducts an ongoing stability program for the Product as required by Applicable Law. Vertical shall provide the results of such testing to Sub-Distributor in a timely manner as this data is generated or received by Vertical. (iii) Sub-Distributor shall have the right to have included in the Product Label Sub-Distributor’s trademarks, tradenames, packaging graphics or similar changes indicating Sub-Distributor as the distributor of the Product. The Parties shall cooperate with each other in effecting the foregoing and Sub-Distributor shall cause such Product Labeling changes described above to be filed with the appropriate Regulatory Authorities in connection with Product’s Regulatory Approvals as required by Applicable Law. (f) Out-of-pocket costs associated with regulatory changes requested by (i) the Regulatory Authority Sub-Distributor which cause finished product, raw materials, labelling labeling and other materials to be discarded will be borne [***] by Distributor and [***] by Cipher, and (ii) Distributor which cause product, raw materials, labelling and other materials to be discarded will be borne one hundred percent (100%) by Sub-Distributor. (h) . The costs of implementing chemistry, manufacturing and control changes or ancillary additional Testing not included in the original Product NDA that is either requested by Sub-Distributor or a Regulatory Authority after the First Commercial Sale first commercial sale of Product in the Market shall be borne one hundred percent (100%) by Sub-Distributor. Sub-Distributor if shall not be responsible for any other regulatory costs or expenses associated with such requested by Distributor and [***] by Distributor and [***] by Cipher if requested by a Regulatory Authoritychanges.

Supply of Products. (a) Cipher Can-Xxxx will be responsible for the Manufacture of Supplied Product and shall cause its Approved Manufacturer and to Manufacture and, if applicable, its Contract Finisher to Package and label the Supplied Product for the Distributor. Except as provided in Section 6.3, the Distributor shall purchase from Cipher Can-Xxxx all of the Distributor’s requirements for the Supplied Product for use in the Field in the Territory during the Term, pursuant to purchase orders submitted by the Distributor or its affiliates Affiliates to Cipher Can-Xxxx from time to time in accordance with Section 6.2. (b) Cipher Except as provided in Section 6.3, Can-Xxxx shall supply or cause the Approved Manufacturer to supply all Supplied Product under this Agreement for use in the Field for distribution in the Territory solely to Distributor in during the agreed upon dosage strengths, labelled package sizes and minimum batch requirements Term in accordance with the terms and conditions of this Agreement (including Schedule B and Schedule E). Cipher shall exercise Commercially Reasonable Efforts to deliver Product to Distributor that has a shelf life and expiration date of at least [***] (but in no event less than [***]) at the date of shipment (it being understood that the failure to have [***] shelf life is not a reason for a Rejection Notice pursuant to Section 6.7)Agreement. (c) Cipher Can-Xxxx and its Approved Manufacturer and if applicable its Contract Finisher Packager shall be responsible for the purchase of adequate supplies of all materials, including including, without limitation, raw materials, in accordance with the NDA NDS and other filings with Regulatory Authorities for the Supplied Product as necessary to supply finished Supplied Product to the Distributor in accordance to with the Specifications and applicable Law. (d) The Supplied Product shall be manufactured with Packaging labeling and packaging as specified by Distributor acting reasonably, including and in accordance with applicable Laws. At least four (i4) identifying Cipher’s Approved Manufacturer as months prior to the manufacturer First Commercial Sale with respect of the Products and Distributor as the distributor thereof, (ii) bearing Distributor’s National Drug Code number, and (iii) including appropriate trademark notices. Within five (5) business days after the Effective Dateeach Supplied Product, Distributor shall, at its sole cost and expense, provide Cipher Can-Xxxx with final specifications for such Packaging labeling and packaging for the ProductsSupplied Product, including all necessary photo-ready artwork (or its substantial equivalent). Distributor, from time to time but not more than one (1) time per year, may update the Packaging labeling and packaging specifications. Such updates shall be subject to the prior written approval of CipherCan-Xxxx, not to be unreasonably withheld, delayed or conditioned. Distributor shall, at Distributor’s expense, use Commercially Reasonable Efforts to secure any approvals required by the FDA Health Canada or any other applicable Regulatory Authority to effect such revisions to the Packaginglabeling and packaging. (e) All costs associated with initial packaging setup incurred by the Contract Finisher will be paid by Cipher and, promptly upon Cipher’s invoice with supporting detail, Distributor shall reimburse Cipher for [***] of such costs, provided that such [***] shall in no event exceed [***]. (f) The terms and conditions of this Agreement shall control the Manufacture and supply of Supplied Product by Cipher Can-Xxxx to Distributor, and no terms or conditions contained in any purchase order, acknowledgment, invoice, xxxx of lading, acceptance or other pre-printed form issued by any Party shall have any force or effect to the extent they are inconsistent with or modify the terms and conditions of this Agreement including those set forth in this Section 6.1, unless mutually agreed in writing by the Parties. (gf) Out-of-pocket costs associated with regulatory changes requested by (i) the Regulatory Authority Health Canada which cause finished product, raw materials, labelling labeling and other materials to be discarded will be shared equally between Distributor and Can-Xxxx, and (ii) Distributor which cause finished product, raw materials, labeling and other materials to be discarded will be borne [***] by Distributor. (g) The costs of implementing, chemistry, manufacturing and controls changes or ancillary additional testing not included in the New Drug Submission that is requested after Regulatory Approval, validation and launch, shall be shared equally between Distributor and [***] Can-Xxxx if requested by Cipher, a Regulatory Authority and (ii) Distributor which cause product, raw materials, labelling and other materials to be discarded will shall be borne one hundred percent (100%) by Distributor. (h) The costs of implementing chemistry, manufacturing and control changes or ancillary additional Testing not included in the original NDA that is either requested by Distributor or a Regulatory Authority after the First Commercial Sale shall be borne one hundred percent (100%) by Distributor if requested by Distributor and [***] by Distributor and [***] by Cipher if requested by a Regulatory AuthorityDistributor.