Common use of Manufacturer/Source Clause in Contracts

Manufacturer/Source. (a) The Parties shall establish an appropriate facility or contract manufacturing organization for handling Finished Manufacture as follows: Rhizen shall be responsible for screening potential manufacturers, negotiating the applicable supply agreement, and effecting the technology transfer as necessary to establish and qualify Bulk API and Finished Product manufacturers, whether those are Rhizen, its Affiliates, or Third Parties; provided, that, TGTX shall have the right to provide reasonable input regarding the terms of such agreements (as well as any amendments thereof), review and comment on agreement drafts and forms, consult with Rhizen regarding the negotiation of such agreements between Rhizen and Third Party contract manufacturers, and conduct a general GMP/regulatory inspection of the proposed manufacturing facilities as the Parties may agree, it being understood that TGTX shall retain the final authority over the terms and conditions of any such agreements with such Third Party contractors.. (b) Notwithstanding 5.2(a), Rhizen shall be responsible for using Diligent Efforts to minimize the manufacturing cost of the Finished Product. In order to ensure a competitive rate of manufacturing cost is obtained, the facility or contract manufacturer used by Rhizen to produce the Finished Product must provide a total manufacturing cost within * % of the cost an alternative contract manufacturing organization of equal repute and quality, where the comparative manufacturing cost are measured as an average of such cost over the immediately preceding Twelve (12) month period. In the event that Rhizen does not provide manufacturing services at the cost required in this Section 5.2(b), then TGTX shall have the right to directly procure manufacturing services in its sole discretion.

Appears in 3 contracts

Sources: Licensing Agreement, Licensing Agreement (Tg Therapeutics, Inc.), Licensing Agreement (Tg Therapeutics, Inc.)

Manufacturer/Source. (a) The Parties shall establish an appropriate facility or contract manufacturing organization for handling Finished Manufacture as follows: Rhizen shall be responsible for screening potential manufacturers, negotiating the applicable supply agreement, and effecting the technology transfer as necessary to establish and qualify Bulk API and Finished Product manufacturers, whether those are Rhizen, its Affiliates, or Third Parties; provided, that, TGTX shall have the right to provide reasonable input regarding the terms of such agreements (as well as any amendments thereof), review and comment on agreement drafts and forms, consult with Rhizen regarding the negotiation of such agreements between Rhizen and Third Party contract manufacturers, and conduct a general GMP/regulatory inspection of the proposed manufacturing facilities as the Parties may agree, it being understood that TGTX Rhizen shall retain the final authority over the terms and conditions of any such agreements with such Third Party contractors unless either of the License Options are exercised, in which case, TGTX would have final authority. In case the manufacturing sources are not the Parties or their Affiliates but rather are Third Party contractors.., then the reasonable costs incurred by the Parties in connection with the establishment of such manufacturing sources shall be treated as Commercial Expenses. (b) Notwithstanding 5.2(a7.4(a), Rhizen shall be responsible for using Diligent Efforts to minimize the manufacturing cost Manufacturing Cost of the Finished Product. In order to ensure a competitive rate of manufacturing cost Manufacturing Cost is obtained, the facility or contract manufacturer used by Rhizen to produce the Finished Product must provide manufacturing services at a total manufacturing cost Manufacturing Cost within * *% of the cost a Manufacturing Cost of an alternative contract manufacturing organization of equal repute and quality, where the comparative manufacturing cost are measured as an average of such cost over the immediately preceding Twelve (12) month period. In the event that Rhizen does not provide manufacturing services at the cost required in this Section 5.2(b7.4(b), then TGTX shall have the right to directly procure manufacturing services in its sole discretion. * Confidential material redacted and filed separately with the Commission.

Appears in 1 contract

Sources: Joint Venture and License Option Agreement (Tg Therapeutics, Inc.)