Common use of Manufacturing Responsibility Clause in Contracts

Manufacturing Responsibility. (a) Until the completion of any transfer of responsibility to CURAGEN as provided in (b) below, TOPOTARGET shall use reasonable commercial efforts, to the extent it is reasonably capable of doing so, to supply CURAGEN, itself or through TOPOTARGET’s use of Third Party manufacturers, with CURAGEN’s requirements for Collaboration Products for use under this Agreement. The cost to CURAGEN of Collaboration Products supplied for use in the Development Program for studies conducted at CURAGEN’s expense, including without limitation studies conducted under the CRADA so long as CURAGEN has rights to use all resulting data in the Territory, shall be [********] of the invoiced price TOPOTARGET pays therefor or [********] of TOPOTARGET’s fully burdened cost of goods sold (which cost shall not include process development costs). Any supply for commercial purposes shall be at a price to be agreed for each Collaboration Product, assuring a reasonable profit to TOPOTARGET. TOPOTARGET shall manufacture Collaboration Products, or shall cause TOPOTARGET’s Third Party manufacturers to manufacture same, in accordance with current Good Manufacturing Practices under 21 C.F.R. 210 and 211 and all applicable laws, rules and regulations. TOPOTARGET shall provide CURAGEN with copies of, or permission to reference, as appropriate, any Drug Master File or similar filing (“DMF”) made by TOPOTARGET with respect to any Collaboration Product, and shall not withdraw or modify any such DMF without prior written notice to CURAGEN. TOPOTARGET shall promptly notify CURAGEN of any event which could materially affect TOPOTARGET’s ability to supply Collaboration Product to CURAGEN hereunder, and shall provide to CURAGEN copies of any correspondence with any regulatory authority that relates to its manufacturing activities with respect to Collaboration Products. (b) Upon request of CURAGEN delivered at any time after the conclusion of the Research Term, TOPOTARGET shall give reasonable consideration to and agrees to discuss with CURAGEN in good faith the possibility of transferring responsibility for manufacturing Collaboration Products for use by CURAGEN from TOPOTARGET to CURAGEN. Any such proposal must take into consideration TOPOTARGET’s own needs for a reliable and economical supply of Collaboration Products.

Manufacturing Responsibility. (a) Until BioNumerik will be responsible for all manufacturing activities of the completion of any transfer of responsibility to CURAGEN as provided in (b) belowProduct, TOPOTARGET shall use reasonable commercial efforts, to including the extent it is reasonably capable of doing so, to supply CURAGEN, itself or through TOPOTARGET’s use of Third Party manufacturersexisting or mutually agreed upon contractor-manufacturers for the manufacture and supply of the Product to Takeda, with CURAGEN’s requirements for Collaboration Products for use under this Agreement. The cost and Takeda agrees to CURAGEN purchase from BioNumerik, Takeda's entire requirement of Collaboration Products supplied for use the Product in the Development Program for studies conducted at CURAGEN’s expense, including without limitation studies conducted Territory under the CRADA so long as CURAGEN has rights conditions set forth herein. BioNumerik agrees to use all resulting data hire only contract-manufacturers that Takeda approves in writing before manufacturing by the Territorycontract-manufacturer begins, shall be [********] provided that Takeda will not unreasonably withhold approval of the invoiced price TOPOTARGET pays therefor or [********] a prospective qualified contract-manufacturer. A list of TOPOTARGET’s fully burdened cost of goods sold (which cost shall not include process development costs). Any supply for commercial purposes shall be at a price to be agreed for each Collaboration Product, assuring a reasonable profit to TOPOTARGET. TOPOTARGET shall manufacture Collaboration Products, or shall cause TOPOTARGET’s Third Party potential contract-manufacturers to manufacture same, in accordance with current Good Manufacturing Practices under 21 C.F.R. 210 and 211 and all applicable laws, rules and regulations. TOPOTARGET shall provide CURAGEN with copies of, or permission to reference, as appropriate, any Drug Master File or similar filing (“DMF”) made that have already been approved by TOPOTARGET with respect to any Collaboration Product, and shall not withdraw or modify any such DMF without prior written notice to CURAGEN. TOPOTARGET shall promptly notify CURAGEN of any event which could materially affect TOPOTARGET’s ability to supply Collaboration Product to CURAGEN hereunder, and shall provide to CURAGEN copies of any correspondence with any regulatory authority that relates to its manufacturing activities with respect to Collaboration ProductsTakeda is set forth on Exhibit G hereto. (b) Upon request of CURAGEN delivered at any time after BioNumerik hereby grants Takeda the conclusion right to audit manufacturing related operations for the Product, including but not limited to audits of the Research Termfollowing: sources, TOPOTARGET shall give reasonable consideration procurement and utilization of raw materials, API production, Final Drug Product production, FDA inspections and reporting, operations involving importation or exportation of raw materials, API or Final Drug Product; label production, carton production, final packaged form of Product production, transportation, quality assurance, and shipping, and inspect the facilities of BioNumerik and its contract-manufacturers that manufacture the Product for the Territory for the foregoing purposes, all subject to Takeda reasonably cooperating with BioNumerik and its contract-manufacturers regarding the timing and scope of any such audits. BioNumerik agrees to discuss substantially comply and to use Commercially Diligent Efforts to cause its contract-manufacturers to substantially comply with CURAGEN (i) Takeda's reasonable advice on quality assurance and (ii) all applicable laws, regulations, guidelines and standards governing manufacture of the Product. Both Parties agree to cooperate with each other in good faith reducing the possibility costs for the manufacture of transferring responsibility for the Product and in keeping a high standard of quality and regulatory compliance regarding the manufacturing Collaboration Products for use by CURAGEN from TOPOTARGET process. (c) BioNumerik will, at its cost, assure that appropriate back-up suppliers are available in the event that BioNumerik or its contract-manufacturers are unable to CURAGEN. Any such proposal must take into consideration TOPOTARGET’s own needs for a reliable and economical supply of Collaboration Productsor are materially delayed in supplying the Product to Takeda.

Manufacturing Responsibility. (a) Until the completion of a successful manufacturing technology transfer to Alvogen hereunder (the “Supply Term”), NRx shall be responsible for and control the manufacturing of Product (and components thereof including Drug Substance and any transfer assembly and packaging of responsibility to CURAGEN as provided finished Products (“Drug Product”)), for qualification of the components required for the manufacture of such Product and preparing, filing and obtaining all related and necessary Registrations (with the exception of the NDA, which is addressed in (b‎Section 3.2) below, TOPOTARGET shall use reasonable commercial efforts, to the extent it is reasonably capable of doing so, to supply CURAGEN, itself or through TOPOTARGET’s use of Third Party manufacturers, with CURAGEN’s requirements necessary for Collaboration Products such manufacture for use all purposes under this Agreement. The cost to CURAGEN of Collaboration Products supplied for use in the Development Program for studies conducted at CURAGEN’s expense, including without limitation studies conducted under the CRADA so long as CURAGEN has rights to use all resulting data for development and Commercialization, in the Territory. As soon as reasonably practicable after the Effective Date, shall be [********] the Parties will negotiate in good faith and enter into a clinical supply agreement (and a related quality agreement) on reasonable and customary terms, in which NRx will supply Alvogen Drug Substance and, if requested by Alvogen, Drug Product, without any markup to the future supply price from Alcami. For clarity, if the cost of the invoiced price TOPOTARGET pays therefor or [********] Product is $1,000 USD per unit, NRx shall invoice Alvogen for $1,000 per unit, without any markup. During the Supply Term, pursuant to the terms of TOPOTARGETthe clinical supply agreement, NRx will manufacture and supply, through Alcami, Alvogen’s fully burdened cost and its Related Parties’ clinical requirements of goods sold (which cost shall not include process Drug Substance and, if applicable, Drug Product for Alvogen’s and its Related Parties’ development costs). Any supply for commercial purposes shall be at a price to be agreed for each Collaboration Product, assuring a reasonable profit to TOPOTARGET. TOPOTARGET shall manufacture Collaboration Products, or shall cause TOPOTARGET’s Third Party manufacturers to manufacture same, in accordance with current Good Manufacturing Practices activities under 21 C.F.R. 210 and 211 and all applicable laws, rules and regulations. TOPOTARGET shall provide CURAGEN with copies of, or permission to reference, as appropriate, any Drug Master File or similar filing (“DMF”) made by TOPOTARGET with respect to any Collaboration Product, and shall not withdraw or modify any such DMF without prior written notice to CURAGEN. TOPOTARGET shall promptly notify CURAGEN of any event which could materially affect TOPOTARGET’s ability to supply Collaboration Product to CURAGEN hereunder, and shall provide to CURAGEN copies of any correspondence with any regulatory authority that relates to its manufacturing activities with respect to Collaboration Productsthis Agreement. (b) Upon request of CURAGEN delivered at any time after the conclusion Prior to initiation of the Research Termfirst Phase 3 Study for a Product, TOPOTARGET shall give reasonable consideration to and agrees to discuss with CURAGEN the Parties will negotiate in good faith and enter into a commercial supply agreement (and a related quality agreement) on reasonable and customary terms, in which NRx will supply Alvogen Drug Substance and, if requested by Alvogen, Drug Product, without any markup to the possibility future supply price from Alcami. For clarity, if the cost of transferring responsibility the Product is $1,000 USD per unit, NRx shall invoice Alvogen for manufacturing Collaboration Products $1,000 per unit, without any markup. During the Supply Term, pursuant to the terms of the commercial supply agreement, NRx will manufacture and supply, through Alcami, Alvogen’s and its Related Parties’ commercial requirements of Drug Substance and, if applicable, Drug Product for use Alvogen’s and its Related Parties’ commercial activities under this Agreement. (c) At any time during the Term after NDA Approval, Alvogen may elect to manufacture, fill and package Product itself or engage one or more Third Parties to manufacture, fill or package Product on its behalf (each, a “Third Party Supplier”); however, such engagement (other than with respect to Third Parties previously engaged by CURAGEN from TOPOTARGET NRx for such purpose) shall be subject to CURAGENthe prior approval of NRx, not to be unreasonably withheld conditioned or delayed; provided, however, that if NRx fails to respond to Xxxxxxx’s request for approval within twenty (20) days of receipt of such request, then such approval shall be considered granted upon the expiration of such twenty (20)-day period. Any such proposal must take into consideration TOPOTARGET’s own needs Xxxxxxx may request in writing that the Parties negotiate in good faith for a reliable period of one hundred eighty (180) days following such request (as such period may be extended by written agreement of the Parties) to establish a written manufacturing technology transfer plan. Such manufacturing technology transfer plan would (a) provide for the transfer from NRx or NRx’s Third Party contract manufacturer to, as mutually agreed by the Parties, either (i) a second source supplier of NRx, (ii) Alvogen, or (iii) Alvogen’s designated Third Party Supplier, copies or samples of all NRx Technology that is necessary or reasonably useful to enable the manufacture of the Product”), (b) provide that NRx or NRx’s Third Party contract manufacturer will provide copies of relevant documentation, samples of Drug Substance, and economical copies of other embodiments of such NRx Technology (including data within reports, notebooks, and electronic files), and (c) provide that NRx will make available its qualified technical personnel on a reasonable basis and as more specifically specified therein to consult with Alvogen with respect to such NRx Technology. Promptly after the manufacturing technology transfer plan is agreed to by the Parties, and in any event no later than sixty (60) days thereafter, NRx will work with Xxxxxxx to complete the transfer of the NRx Technology and other activities set forth in the manufacturing technology transfer plan on the timelines set forth therein. At the request of Alvogen, NRx shall cooperate with and reasonably assist Xxxxxxx to negotiate and enter into commercial supply agreements with any of Collaboration ProductsNRx’s existing Third Party suppliers or to assume such agreements.