Supply of Licensed Product Sample Clauses

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. (a) Merck Serono shall transfer to ZGI all then-existing clinical and commercial stocks of the Licensed Product, and shall also complete any on-going manufacturing runs and supply the Licensed Product made in such runs to ZGI, in each such case [ * ], except with respect to stocks or manufacturing runs the costs of which were included in the quarterly accountings and balancing payments under the Original Agreement (which stocks and manufacturing runs shall be provided by Merck Serono under this clause without any further charge to ZGI). (b) To the extent supplies in addition to those to be provided under subsection (a) above are required, Merck Serono shall, at all times between the effectiveness of its termination of such roles and responsibilities pursuant to Section 4.2 and [ * ], manufacture and supply to ZGI all of ZGI’s and its Affiliates’ and Sublicensees’ worldwide requirements for the Licensed Product, provided such requirements do not exceed [ * ] of the requirements for the Licensed Product for that period described in Merck Serono’s bona fide internal projections. ZGI shall exert [ * ] to find and qualify an alternative manufacturing source for such Licensed Product as promptly as possible, and, unless ZGI terminates this supply arrangement earlier at its option, ZGI, [ * ], shall purchase all of such requirements from Merck Serono, which Licensed Products will be supplied pursuant to a supply agreement [ * ]. (c) If and to the extent that any Merck Serono Production Technology in existence on the effective date of such termination that is applicable to such Licensed Product is not already covered by Merck Serono’s licenses to ZGI under Section 8.4, the same shall hereby be deemed to be included in such licenses, but on a nonexclusive basis. (d) Merck Serono shall promptly provide to ZGI a full disclosure of all Merck Serono Production Technology, if any, that shall not have prior thereto been provided to ZGI to the extent the same is reasonably necessary to enable an experienced cGMP manufacturer to manufacture the applicable Licensed Product. Merck Serono further agrees to cooperate in the transfer of manufacturing operations for such Licensed Product to ZGI or its designated Sublicensee or contract manufacturer and agrees to provide all information, data, and copies of documents constituting Merck Serono Production Technology reasonably necessary or useful for regulatory filings (including authorization to use such information, data and copi...

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. 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. 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. 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. 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. Nuvelo shall supply, free of charge, all of Bayer’s requirements for clinical supplies of Licensed Product for Global Development Programs, the manufacturing costs of which shall be included in Development Expenses. In addition, the Parties will use diligent efforts to negotiate and complete a manufacturing, supply and quality agreement within six (6) months after the Effective Date, pursuant to which Nuvelo will supply Bayer with, and Bayer will purchase from Nuvelo, all of Bayer’s requirements for Licensed Product for use in Country Specific Trials in the Bayer Territory and commercial sales of Licensed Product in the Bayer Territory (the “Manufacturing Agreement”). Among other items, the Manufacturing Agreement will provide the following: (a) Subject to Section 7.2, Nuvelo will supply Bayer with unlabeled Licensed Product FOB the manufacturing facility of Nuvelo or its contract manufacturer in sufficient quantities for Bayer’s use in connection with the Development and Commercialization of Licensed Product in the Bayer Territory. (b) Subject to Section 7.1(c), Nuvelo will have the right to make all decisions with respect to manufacturing in its sole discretion, including without limitation, decisions relating to process development and manufacturing procedures, work to support quality assurance, improving manufacturing/cost efficiency and commercial scale-up manufacturing, provided that Nuvelo will manufacture or have the Licensed Product manufactured in conformity with all applicable laws and regulations in the Major Countries and will use Commercially Reasonable Efforts to manufacture or have manufactured the Licensed Product in conformity with all applicable laws and regulations in all other countries in the Bayer Territory and in conformity with all Licensed Product specifications set forth in the Manufacturing Agreement. Nuvelo shall timely notify Bayer of any manufacturing change that may have an impact on Bayer’s ability to timely receive Regulatory Approval or jeopardize current status of the Licensed Product in the Bayer Territory and in connection with any such change Nuvelo shall supply any information or documents or support any actions required to facilitate Bayer’s commercialization efforts. (c) Unless otherwise agreed by the Parties, Bayer will have final decision making authority to fulfill all regulatory responsibilities over all subsequent steps of the manufacturing process for Licensed Product in the Bayer Territory (including finish ...

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.” 7. Section 4.1(a) – (e) of the License is amended and restated in its entirety as follows: (a) Effective Date US$50,000 (b) Initiation anywhere in the Territory of 505b2 strategy registration studies or one Phase III Clinical Study for the regular NDA approval process for any Licensed Product US$[*] (c) Initiation of first Clinical Study of Oradoxel in any country in the Territory US$[*] (d) Initiation of a Phase III Clinical Study of Oradoxel in any country in the Territory US$[*] (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, PharmaEssentia shall pay to Athenex US$2.0M on or before December 15, 2018.