Sale and Purchase of Manufactured Products. (a) Subject to the terms and on the conditions set forth in this Agreement, as soon as reasonably practicable after the date that CCT obtains Regulatory Clearance and/or Approval in the United States for an ECM, CCT shall supply and sell to Alliqua, and Alliqua shall purchase from CCT, Alliqua’s entire requirements of Manufactured Products, in finished form and final packaging, for exploitation in the Territory under the License Agreement. The form and packaging of any Manufactured Products shall be in accordance with such specifications for such Manufactured Product (the “Specifications”) that are hereafter agreed to by the Parties. As soon as reasonably practicable after the Effective Date, the Parties shall endeavor in good faith to agree in writing upon the Specifications. For purposes of the immediately preceding sentence, neither Party may propose specifications that (i) would conflict with the specifications comprising a part of CCT’s application for Regulatory Clearance and/or Approval of such Manufactured Product, or (ii) would materially increase the documented cost of manufacturing finished form of Manufactured Product and/or the documented cost of final packaging of such Manufactured Product. Following the date that CCT obtains Regulatory Clearance and/or Approval in the United States for an ECM, the Parties will agree to any changes to the Specifications that are necessary in order for the Specifications for such ECM to not conflict with the applicable Regulatory Clearance and/or Approval. THE COMPANY HAS REQUESTED AN ORDER FROM THE SECURITIES AND EXCHANGE COMMISSION (THE “COMMISSION”) PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, GRANTING CONFIDENTIAL TREATMENT TO SELECTED PORTIONS. ACCORDINGLY, THE CONFIDENTIAL PORTIONS HAVE BEEN OMITTED FROM THIS EXHIBIT, AND HAVE BEEN FILED SEPARATELY WITH THE COMMISSION. OMITTED PORTIONS ARE INDICATED IN THIS EXHIBIT WITH “*****”. (b) CCT shall manufacture, store at its facility, and test all finished Manufactured Products or cause the same to be manufactured, stored at the manufacturing facility, and tested, in conformity with the applicable Specifications for such Manufactured Product and in compliance with all applicable Law, including cGMPs, and the terms and conditions of this Agreement and the Quality Agreement. CCT’s responsibility for finished packaging of the Manufactured Product will include supply to Alliqua of the Manufactured Products in finished packaging (including (i) sterile pouch inner packaging, with the appropriate labels affixed to such inner packaging (such pouch inner packaging and labeling as reasonably determined by CCT (following consultation with, and taking into account input from, the JSC) in compliance with applicable Law and Regulatory Clearance and/or Approval), (ii) outer cartons and outer carton labeling and (iii) package inserts) all as further detailed in the applicable Specifications, with tracking letters to the extent required under applicable Law . For the avoidance of doubt, except as provided in Section 2.1(c) below, CCT will not charge Alliqua any amounts for such packaging that are in addition to the Purchase Price. (c) Alliqua either will: (i) provide CCT, at Alliqua’s cost, with the outer cartons for the Manufactured Product finished packaging (the “Outer Cartons”) or (ii) direct CCT to procure the Outer Cartons from a supplier designated by Alliqua. If Alliqua directs CCT to procure the Outer Cartons, then the per unit cost charged by the Outer Carton supplier will be added to the Purchase Price, without markup, for each Manufactured Product. In addition, Alliqua, at its cost, will provide CCT with all outer carton labels, package inserts and, to the extent required, preprinted tracking letters, in each case for CCT to include in the finished Manufactured Products. Alliqua also shall be responsible for providing CCT with all required artwork to be used in connection therewith. (d) Subject to any legal requirements under applicable Law, CCT may, at its sole option, engage or use subcontractors and suppliers that it reasonably believes are qualified to perform some or all of CCT’s obligations under this Agreement (each, a “Permitted Subcontractor”). (e) Without limiting the foregoing, all Permitted Subcontractors shall be subject to the applicable terms and conditions of this Agreement and the Quality Agreement and no agreement with any Permitted Subcontractor shall release CCT from any of its obligations under this Agreement or the Quality Agreement. CCT shall remain responsible for any services performed by such Permitted Subcontractor to the same extent as if it had performed the obligations itself. THE COMPANY HAS REQUESTED AN ORDER FROM THE SECURITIES AND EXCHANGE COMMISSION (THE “COMMISSION”) PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, GRANTING CONFIDENTIAL TREATMENT TO SELECTED PORTIONS. ACCORDINGLY, THE CONFIDENTIAL PORTIONS HAVE BEEN OMITTED FROM THIS EXHIBIT, AND HAVE BEEN FILED SEPARATELY WITH THE COMMISSION. OMITTED PORTIONS ARE INDICATED IN THIS EXHIBIT WITH “*****”. (f) For the purposes of clarity, nothing in this Agreement shall provide a right of reference to support any filing by Alliqua or an Alliqua Affiliate with the FDA for any product other than the Manufactured Products or to support any similar filing with another Governmental Authority in or out of the Territory.
Appears in 1 contract
Sale and Purchase of Manufactured Products. (a) Subject to the terms and on the conditions set forth in this Agreement, as soon as reasonably practicable after the date that CCT obtains Regulatory Clearance and/or Approval in the United States for an ECMcommencing no earlier than April 1, 2014, CCT shall supply and sell to Alliqua, and Alliqua shall purchase from CCT, Alliqua’s entire requirements of bulk Manufactured Products, in finished form and final packaging, Products for exploitation in the Territory under the License Agreement. The bulk form and bulk packaging of any Manufactured Products shall be in accordance with such specifications for such Manufactured Product (the “Specifications”) that are hereafter agreed to by the Parties. As soon as reasonably practicable after the Effective Date, the Parties shall endeavor in good faith to agree in writing upon the Specifications. For purposes of the immediately preceding sentence, neither Party may propose specifications that (i) would conflict with the specifications comprising a part of CCT’s application for Regulatory Clearance and/or Approval of such Manufactured Product, or (ii) would materially increase the documented cost of manufacturing finished form of Manufactured Product and/or the documented cost of final packaging of such Manufactured Product. Following the date that CCT obtains Regulatory Clearance and/or Approval in the United States for an ECM, the Parties will agree to any changes to the Specifications that are necessary in order for the Specifications for such ECM to not conflict with the applicable Regulatory Clearance and/or Approval. THE COMPANY HAS REQUESTED AN ORDER FROM THE SECURITIES AND EXCHANGE COMMISSION (THE “COMMISSION”) PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, GRANTING CONFIDENTIAL TREATMENT TO SELECTED PORTIONS. ACCORDINGLY, THE CONFIDENTIAL PORTIONS HAVE BEEN OMITTED FROM THIS EXHIBIT, AND HAVE BEEN FILED SEPARATELY WITH THE COMMISSION. OMITTED PORTIONS ARE INDICATED IN THIS EXHIBIT WITH “*****”.
(b) CCT shall manufacture, store at its facility, and test all finished bulk Manufactured Products or cause the same to be manufactured, stored at the manufacturing facility, and tested, in conformity with the applicable Specifications for such Manufactured Product and in compliance with all applicable Law, including cGMPscGTPs, and the terms and conditions of this Agreement and the Quality Agreement. CCT’s responsibility for finished packaging of the Manufactured Product will include supply to Alliqua of the Manufactured Products in finished packaging (including (i) sterile pouch inner packaging, with the appropriate labels affixed to such inner packaging (such pouch inner packaging and labeling as reasonably determined by CCT (following consultation with, and taking into account input from, the JSC) in compliance with applicable Law and Regulatory Clearance and/or Approval), (ii) outer cartons and outer carton labeling and (iii) package inserts) all as further detailed in the applicable Specifications, with tracking letters to the extent required under applicable Law . For the avoidance of doubt, except as provided in Section 2.1(c) below, CCT will not charge Alliqua any amounts for such packaging that are in addition to the Purchase Price.
(c) Alliqua either will: (i) provide CCTshall be solely responsible for all labels, at Alliqua’s costlabeling, with the outer cartons for the tracking letters, and packaging of finished Manufactured Product finished packaging (the “Outer Cartons”) or (ii) direct CCT to procure the Outer Cartons from a supplier designated by Alliqua. If Alliqua directs CCT to procure the Outer CartonsProducts, then the per unit cost charged by the Outer Carton supplier will be added to the Purchase Price, without markup, including package inserts and outserts for each Manufactured Product. In addition, Alliqua, at its cost, will provide CCT with all outer carton labels, package inserts and, to the extent required, preprinted tracking letters, in each case for CCT to include Product in the finished Manufactured Products. Alliqua also shall be responsible for providing CCT with all required artwork to be used in connection therewithTerritory.
(d) Subject to any legal requirements under applicable Law, CCT may, at its sole option, engage or use subcontractors and suppliers that it reasonably believes are qualified to perform some or all of CCT’s obligations under this Agreement (each, a “Permitted Subcontractor”).
(e) Without limiting the foregoing, all Permitted Subcontractors shall be subject to the applicable terms and conditions of this Agreement and the Quality Agreement and no agreement with any Permitted Subcontractor shall release CCT from any of its obligations under this Agreement or the Quality Agreement. CCT shall remain responsible for any services performed by such Permitted Subcontractor to the same extent as if it had performed the obligations itself. THE COMPANY HAS REQUESTED AN ORDER FROM THE SECURITIES AND EXCHANGE COMMISSION (THE “COMMISSION”) PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, GRANTING CONFIDENTIAL TREATMENT TO SELECTED PORTIONS. ACCORDINGLY, THE CONFIDENTIAL PORTIONS HAVE BEEN OMITTED FROM THIS EXHIBIT, AND HAVE BEEN FILED SEPARATELY WITH THE COMMISSION. OMITTED PORTIONS ARE INDICATED IN THIS EXHIBIT WITH “*****”.
(f) For the purposes of clarity, nothing in this Agreement shall provide a right of reference to support any filing by Alliqua or an Alliqua Affiliate with the FDA for any product other than the Manufactured Products or to support any similar filing with another Governmental Authority in or out of the Territory.
Appears in 1 contract
Samples: Supply Agreement (Celgene Corp /De/)
Sale and Purchase of Manufactured Products. (a) Subject to the terms and on the conditions set forth in this Agreement, as soon as reasonably practicable after the date that CCT obtains Regulatory Clearance and/or Approval in the United States for an ECMcommencing no earlier than [***], CCT shall supply and sell to Alliqua, and Alliqua shall purchase from CCT, Alliqua’s entire requirements of bulk Manufactured Products, in finished form and final packaging, Products for exploitation in the Territory under the License Agreement. The bulk form and bulk packaging of any Manufactured Products shall be in accordance with such specifications for such Manufactured Product (the “Specifications”) that are hereafter agreed to by the Parties. As soon as reasonably practicable after the Effective Date, the Parties shall endeavor in good faith to agree in writing upon the Specifications. For purposes of the immediately preceding sentence, neither Party may propose specifications that (i) would conflict with the specifications comprising a part of CCT’s application for Regulatory Clearance and/or Approval of such Manufactured Product, or (ii) would materially increase the documented cost of manufacturing finished form of Manufactured Product and/or the documented cost of final packaging of such Manufactured Product. Following the date that CCT obtains Regulatory Clearance and/or Approval in the United States for an ECM, the Parties will agree to any changes to the Specifications that are necessary in order for the Specifications for such ECM to not conflict with the applicable Regulatory Clearance and/or Approval. THE COMPANY HAS REQUESTED AN ORDER FROM THE SECURITIES AND EXCHANGE COMMISSION (THE “COMMISSION”) PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, GRANTING CONFIDENTIAL TREATMENT TO SELECTED PORTIONS. ACCORDINGLY, THE CONFIDENTIAL PORTIONS HAVE BEEN OMITTED FROM THIS EXHIBIT, AND HAVE BEEN FILED SEPARATELY WITH THE COMMISSION. OMITTED PORTIONS ARE INDICATED IN THIS EXHIBIT WITH “*****”.
(b) CCT shall manufacture, store at its facility, and test all finished bulk Manufactured Products or cause the same to be manufactured, stored at the manufacturing facility, and tested, in conformity with the applicable Specifications for such Manufactured Product and in compliance with all applicable Law, including cGMPscGTPs, and the terms and conditions of this Agreement and the Quality Agreement. CCT’s responsibility for finished packaging of the Manufactured Product will include supply to Alliqua of the Manufactured Products in finished packaging (including (i) sterile pouch inner packaging, with the appropriate labels affixed to such inner packaging (such pouch inner packaging and labeling as reasonably determined by CCT (following consultation with, and taking into account input from, the JSC) in compliance with applicable Law and Regulatory Clearance and/or Approval), (ii) outer cartons and outer carton labeling and (iii) package inserts) all as further detailed in the applicable Specifications, with tracking letters to the extent required under applicable Law . For the avoidance of doubt, except as provided in Section 2.1(c) below, CCT will not charge Alliqua any amounts for such packaging that are in addition to the Purchase Price.
(c) Alliqua either will: (i) provide CCTshall be solely responsible for all labels, at Alliqua’s costlabeling, with the outer cartons for the tracking letters, and packaging of finished Manufactured Product finished packaging (the “Outer Cartons”) or (ii) direct CCT to procure the Outer Cartons from a supplier designated by Alliqua. If Alliqua directs CCT to procure the Outer CartonsProducts, then the per unit cost charged by the Outer Carton supplier will be added to the Purchase Price, without markup, including package inserts and outserts for each Manufactured Product. In addition, Alliqua, at its cost, will provide CCT with all outer carton labels, package inserts and, to the extent required, preprinted tracking letters, in each case for CCT to include Product in the finished Manufactured Products. Alliqua also shall be responsible for providing CCT with all required artwork to be used in connection therewithTerritory.
(d) Subject to any legal requirements under applicable Law, CCT may, at its sole option, engage or use subcontractors and suppliers that it reasonably believes are qualified to perform some or all of CCT’s obligations under this Agreement (each, a “Permitted Subcontractor”).
(e) Without limiting the foregoing, all Permitted Subcontractors shall be subject to the applicable terms and conditions of this Agreement and the Quality Agreement and no agreement with any Permitted Subcontractor shall release CCT from any of its obligations under this Agreement or the Quality Agreement. CCT shall remain responsible for any services performed by such Permitted Subcontractor to the same extent as if it had performed the obligations itself. THE COMPANY HAS REQUESTED AN ORDER FROM THE SECURITIES AND EXCHANGE COMMISSION (THE “COMMISSION”) PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, GRANTING CONFIDENTIAL TREATMENT TO SELECTED PORTIONS. ACCORDINGLY, THE CONFIDENTIAL PORTIONS HAVE BEEN OMITTED FROM THIS EXHIBIT, AND HAVE BEEN FILED SEPARATELY WITH THE COMMISSION. OMITTED PORTIONS ARE INDICATED IN THIS EXHIBIT WITH “*****”.
(f) For the purposes of clarity, nothing in this Agreement shall provide a right of reference to support any filing by Alliqua or an Alliqua Affiliate with the FDA for any product other than the Manufactured Products or to support any similar filing with another Governmental Authority in or out of the Territory.
Appears in 1 contract
Samples: Supply Agreement (Celgene Corp /De/)
Sale and Purchase of Manufactured Products. (a) Subject to the terms and on the conditions set forth in this Agreement, as soon as reasonably practicable after the date that CCT obtains Regulatory Clearance and/or Approval in the United States for an ECMcommencing no earlier than April 1, 2014, CCT shall supply and sell to Alliqua, and Alliqua shall purchase from CCT, Alliqua’s entire requirements of bulk Manufactured Products, in finished form and final packaging, Products for exploitation in the Territory under the License Agreement. The bulk form and bulk packaging of any Manufactured Products shall be in accordance with such specifications for such Manufactured Product (the “Specifications”) that are hereafter agreed to by the Parties. As soon as reasonably practicable after the Effective Date, the Parties shall endeavor in good faith to agree in writing upon the Specifications. For purposes of the immediately preceding sentence, neither Party may propose specifications that (i) would conflict with the specifications comprising a part of CCT’s application for Regulatory Clearance and/or Approval of such Manufactured Product, or (ii) would materially increase the documented cost of manufacturing finished form of Manufactured Product and/or the documented cost of final packaging of such Manufactured Product. Following the date that CCT obtains Regulatory Clearance and/or Approval in the United States for an ECM, the Parties will agree to any changes to the Specifications that are necessary in order for the Specifications for such ECM to not conflict with the applicable Regulatory Clearance and/or Approval. THE COMPANY HAS REQUESTED AN ORDER FROM THE SECURITIES AND EXCHANGE COMMISSION (THE “COMMISSION”) PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, GRANTING CONFIDENTIAL TREATMENT TO SELECTED PORTIONS. ACCORDINGLY, THE CONFIDENTIAL PORTIONS HAVE BEEN OMITTED FROM THIS EXHIBIT, AND HAVE BEEN FILED SEPARATELY WITH THE COMMISSION. OMITTED PORTIONS ARE INDICATED IN THIS EXHIBIT WITH “*****”.
(b) CCT shall manufacture, store at its facility, and test all finished bulk Manufactured Products or cause the same to be manufactured, stored at the manufacturing facility, and tested, in conformity with the applicable Specifications for such Manufactured Product and in compliance with all applicable Law, including cGMPscGTPs, and the terms and conditions of this Agreement and the Quality Agreement. CCT’s responsibility for finished packaging of the Manufactured Product will include supply to Alliqua of the Manufactured Products in finished packaging (including (i) sterile pouch inner packaging, with the appropriate labels affixed to such inner packaging (such pouch inner packaging and labeling as reasonably determined by CCT (following consultation with, and taking into account input from, the JSC) in compliance with applicable Law and Regulatory Clearance and/or Approval), (ii) outer cartons and outer carton labeling and (iii) package inserts) all as further detailed in the applicable Specifications, with tracking letters to the extent required under applicable Law . For the avoidance of doubt, except as provided in Section 2.1(c) below, CCT will not charge Alliqua any amounts for such packaging that are in addition to the Purchase Price.
(c) Alliqua either will: (i) provide CCTshall be solely responsible for all labels, at Alliqua’s costlabeling, with the outer cartons for the tracking letters, and packaging of finished Manufactured Product finished packaging (the “Outer Cartons”) or (ii) direct CCT to procure the Outer Cartons from a supplier designated by Alliqua. If Alliqua directs CCT to procure the Outer CartonsProducts, then the per unit cost charged by the Outer Carton supplier will be added to the Purchase Price, without markup, including package inserts and outserts for each Manufactured Product. In addition, Alliqua, at its cost, will provide CCT with all outer carton labels, package inserts and, to the extent required, preprinted tracking letters, in each case for CCT to include Product in the finished Manufactured Products. Alliqua also shall be responsible for providing CCT with all required artwork to be used in connection therewithTerritory.
(d) Subject to any legal requirements under applicable Law, CCT may, at its sole option, engage or use subcontractors and suppliers that it reasonably believes are qualified to perform some or all of CCT’s obligations under this Agreement (each, a “Permitted Subcontractor”).
(e) Without limiting the foregoing, all Permitted Subcontractors shall be subject to the applicable terms and conditions of this Agreement and the Quality Agreement and no agreement with any Permitted Subcontractor shall release CCT from any of its obligations under this Agreement or the Quality Agreement. CCT shall remain responsible for any services performed by such Permitted Subcontractor to the same extent as if it had performed the obligations itself. THE COMPANY HAS REQUESTED AN ORDER FROM THE SECURITIES AND EXCHANGE COMMISSION (THE “COMMISSION”) PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, GRANTING CONFIDENTIAL TREATMENT TO SELECTED PORTIONS. ACCORDINGLY, THE CONFIDENTIAL PORTIONS HAVE BEEN OMITTED FROM THIS EXHIBIT, AND HAVE BEEN FILED SEPARATELY WITH THE COMMISSION. OMITTED PORTIONS ARE INDICATED IN THIS EXHIBIT WITH “*****”.
(f) For the purposes of clarity, nothing in this Agreement shall provide a right of reference to support any filing by Alliqua or an Alliqua Affiliate with the FDA for any product other than the Manufactured Products or to support any similar filing with another Governmental Authority in or out of the Territory.
Appears in 1 contract
Samples: Supply Agreement (Alliqua, Inc.)
