Supply of Licensed Product. During the Agreement Term, Hanmi shall use its best efforts to assist Kinex to procure, in accordance with regulatory requirements and as requested by Kinex, the requirements for Licensed Products for Clinical Studies and Regulatory Approval in the Territory. If Hanmi is directly manufacturing the Licensed Product for its own purposes, it shall supply the Licensed Product to Kinex at a purchase price payable by Kinex equal to Hanmi’s cost for manufacturing the Licensed Products. For the avoidance of doubt, Kinex shall be responsible for any customs duties. If Kinex elects to directly manufacture its own investigational products containing any Compound, Hanmi shall have the right to purchase such investigational products from Kinex for Clinical Studies and Regulatory Approval outside the Territory at a purchase price payable by Hanmi equal to Kinex’s cost for manufacturing the investigational products.
Supply of Licensed Product. At Takeda’s written request, Licensee will make available for Takeda to purchase any quantities of the Terminated Compound and Terminated Products or the TAK-385 Licensed Compound and TAK-385 Licensed Products in the event of termination with respect to a Terminated Field (in bulk drug substance, bulk drug product, or finished drug product form, as requested by Takeda) then in Licensee’s possession or control as Takeda indicates in written orders therefor from time to time at a price equal to Licensee’s [***] (where Licensee Manufactured such quantities), or at the same cost as Licensee paid to Takeda for such quantities (where Takeda Manufactured such quantities) in its most recent invoice. If requested, Licensee will Manufacture or have Manufactured such Terminated Compound and Terminated Products (or the TAK-385 Licensed Compound and TAK-385 Licensed Products) for supply to Takeda until the later of (i) such time as Takeda has established an alternate, validated source of supply for the Terminated Compound and Terminated Products (or the TAK-385 Licensed Compound and TAK-385 Licensed Products) and Takeda is receiving supply from such alternative source and (ii) the [***] month anniversary of the effective date of termination of this Agreement with respect to the applicable Terminated Compound or Terminated Products (or the TAK-385 Licensed Compound and TAK-385 Licensed Products).
Supply of Licensed Product. As set forth in Schedule 10.4 (c) Part I (E) of the License Agreement, Merck agrees to supply to Idera , upon request and payment, and for a period of up to [**] months following the Effective Date, with its available and existing stock of Compounds, Follow-on Compounds, and Licensed Product. A list of available Compounds, Follow-on Compounds, and Licensed Product and the fully burdened cost thereof (but excluding the [**]% xxxx up due under Schedule 10.4 (c) (E) that is applicable to delivery of Compounds, Follow-on Compounds or Licensed Product) is attached to this Agreement as Schedule 4. Idera shall be able to obtain any or all of the listed stocks and if purchased, Merck shall provide Idera or its designee with the Merck IP (excluding the Trademark) with respect to the manufacture of each such Compound, Follow-on Compound or Licensed Product. The Parties recognize and agree that certain Compounds, Follow-on Compounds, and Licensed Products were manufactured without using Merck IP and only those Compounds, Follow-on Compounds, and Licensed Products manufactured using Merck IP shall be subject to the Reverse Royalty set forth in Section 5.4. The Parties recognize and agree that Idera may, without relying upon or using any Merck IP, develop new manufacturing processes that may be similar or the same as the manufacturing processes included in the Merck IP. If Idera develops such manufacturing process without relying upon or using any Merck IP, then no Reverse Royalties will be due on Compounds, Follow-on Compounds, or Licensed Products manufactured by Idera with that manufacturing process. For clarity, if Idera purchases Compound, Follow-on Compound or Licensed Product manufactured with Merck IP, Idera is obliged to take a license to Merck IP and the Reverse Royalities in Article 5.3 will be due if such Merck IP is used for Compound, Follow-on Compound or Licensed Product. Merck will destroy those materials listed in Schedule 4 not purchased by Idera within a reasonable time following [**] months of the Effective Date, and Idera´s option to take a worldwide license to the Merck IP, excluding the Trademark, will expire.
Supply of Licensed Product. Licensee shall purchase its supply of Licensed Product, and GPC Biotech agrees to supply to Licensee such quantities subject to the terms of the Supply Agreement.
Supply of Licensed Product. Except as otherwise agreed upon by the Parties, Licensee shall be solely responsible for manufacturing or having manufactured, at its cost and expense and in accordance with applicable Law, sufficient clinical and commercial quantities of the Licensed Product to fulfill Licensee’s development and commercial obligations hereunder. Notwithstanding the foregoing, upon request by Licensee, Pulmokine shall sell to Licensee at Pulmokine’s cost of goods plus delivery costs some or all quantities of the Backup Compound or Asthma Compounds active pharmaceutical ingredient (API) and/or Licensed Product containing same and/or Biomarkers in Pulmokine’s possession and some or all quantities of the Compound active pharmaceutical ingredient (API) and/or Licensed Product containing same in Pulmokine’s possession following its completion of the Phase 1A clinical trial.
Supply of Licensed Product. Until such time as Company has a direct agreement with each of the CMOs that is a party to an Unassigned Contract for the manufacture of ASN007, Asana shall provide to Company supplies of Licensed Product (including final product, bulk drug substance, intermediates, works-in-process, formulation materials, reference standards, drug product clinical reserve samples, packaged retention samples with respect thereto), obtained in accordance with the terms and conditions of the applicable Unassigned Contract, at a price equal to Asana’s fully burdened manufacturing cost, including the pass through of Asana’s purchase price for such Licensed Product from such CMO and costs incurred by Asana and allocable to such Licensed Product in accordance with United States generally accepted accounting principles, including costs of shipping, handling, quality assurance and storage, for up to twelve (12) months after the Effective Date, under the terms of a commercially reasonable supply agreement to be negotiated in good faith by the Parties. For clarity, Asana shall not be obligated to enter into any supply arrangements for the Licensed Product (or any component thereof) other than the Unassigned Contracts, or to obtain Licensed Products (or any component thereof) other than pursuant to the Unassigned Contracts, to satisfy its supply obligations under this Section 4.3.
Supply of Licensed Product. Kinex shall supply PharmaEssentia free of charge, in accordance with regulatory requirements and as requested in writing by PharmaEssentia, the Licensed Products that are sufficient for the Clinical Studies (up to 80 patients) in the Territory.
Supply of Licensed Product. During the Term, if TolerRx wants Genentech to supply Licensed Products to TolerRx so that TolerRx may fulfill its development obligations under Section 3.4(c) of this Agreement, the Parties agree to negotiate in good faith regarding Genentech supplying a reasonable amount of Licensed Products to TolerRx at Fully Burdened Manufacturing Cost (as defined in Exhibit A). For clarity, Genentech shall not be obligated to supply Licensed Products to TolerRx with respect to Section 3.4(b) unless approved by the JSC in the manner set forth in Section 2.2. As a condition of the foregoing, Genentech shall be obligated to negotiate only if Genentech determines that supplying such Licensed Products does not adversely affect the Licensed Product (including but not limited to supply of Licensed Product for clinical testing) or Genentech's other products. In no event shall Genentech be obligated to manufacture any Licensed Products for TolerRx, except to the limited extent expressly set forth in Section 9.5(c)(iii).
Supply of Licensed Product. Kinex shall supply PharmaEssentia free of charge, in accordance with regulatory requirements and as requested in writing by PharmaEssentia, the Licensed Products that are sufficient for the Clinical Studies (up to 80 patients) in the Territory, except for Oradoxel. For Oradoxel, Kinex shall supply PharmaEssentia, in accordance with regulatory requirements and as requested in writing by PharmaEssentia, Oradoxel sufficient for Clinical Trials in the Territory and PharmaEssentia shall be responsible to Kinex for the reasonable cost and expense of such supply.”
Section 4.1 (a) – (e) of the License is amended and restated in its entirety as follows:
(a) Effective Date US$50,000
(b) Initiation anywhere in the Territory of 505b2 strategy registration studies or one Phase III Clinical Study for the regular NDA approval process for any Licensed Product US$0.5M
(c) Initiation of first Clinical Study of Oradoxel in any country in the Territory US$[*]
(d) Initiation of a Phase III Clinical Study of Oradoxel in any country in the Territory US$[*] US$[*]
(e) Filing of an NDA for the Regulatory Approval for Oradoxel in any country in the Territory US$[*]
(f) Filing of an NDA for the Regulatory Approval for Oradoxel in any country in the Territory US$[*]
(g) Filing of an NDA for the Regulatory Approval for Oratecan in any country in the Territory US$[*]
(h) Regulatory Approval of Oradoxel in Taiwan US$[*]
(i) Regulatory Approval of Oradoxel in Singapore US$[*]
(j) Regulatory Approval of any Licensed Products in the Territory US$[*] [*] Confidential treatment requested; certain information omitted and filed separately with the SEC
8. In consideration for this Second Amendment, Pharma Essentia shall pay to Athenex US$2.0M on or before December 15, 2018.
Supply of Licensed Product. (a) Subject to this Section 4.10 and Section 4.12, SELLAS shall be responsible for Manufacturing all quantities of the Licensed Products necessary for 3DMed to Develop and Commercialize the Licensed Products in the Field in the Territory until 3DMed has received all Approvals required for 3DMed or its designated contract manufacturing organization to Manufacture the Licensed Products in the Territory (the “Supply End Date”). Following the Supply End Date, 3DMed shall be responsible at its sole cost for Manufacturing all quantities of the Licensed Products necessary for 3DMed to Develop and Commercialize Licensed Products in the Field in the Territory. For the avoidance of doubt, notwithstanding any provision to the contrary in either the Clinical Supply Agreement or the Commercial Supply Agreement (each as defined below), SELLAS’s obligation to Manufacture and supply quantities of the Licensed Products for 3DMed shall terminate on the Supply End Date.
(b) 3DMed acknowledges and agrees that SELLAS has engaged certain Third Party contract research organizations, consultants and contract manufacturers to Develop and Manufacture the Licensed Products on behalf of SELLAS and that SELLAS’s obligations to engage in the data sharing contemplated by Section 4.9, to provide Technical Assistance and supply quantities of the Licensed Products to 3DMed shall be subject to, and limited by, the terms of SELLAS’s agreements with such Third Party contract research organizations, consultants and contract manufacturers. The Clinical Supply Agreement and the Commercial Supply Agreement shall set forth the extent to which SELLAS shall remain responsible for the performance and non-performance of such Third Party contract research organizations, consultants and contract manufacturers.
(c) Within [***] after the Effective Date, the Parties shall negotiate in good faith the terms of and enter into a clinical supply agreement (the “Clinical Supply Agreement”) and a related quality agreement (the “Clinical Supply Quality Agreement”) pursuant to which SELLAS shall supply to 3DMed quantities of the Licensed Products in bulk, unlabeled form [***] to support the Development of Licensed Products in the Field in the Territory. The Clinical Supply Agreement and Clinical Supply Quality Agreement shall contain terms that are consistent with SELLAS’s agreements with any applicable Third Party contract research organization, consultant or contract manufacturer and such other terms that are cu...
