Common use of Global Material & Supply Rights Clause in Contracts

Global Material & Supply Rights. Rhizen shall retain exclusive rights for manufacturing and supply of API and formulations for global development and commercialization; provided however, that Rhizen’s price is cost competitive (as described in 5.2(b)) and prior to the First Commercial Sale, the Parties shall timely negotiate in good faith and enter into a manufacturing and supply agreement. Such Commercial Supply Agreement shall contain customary terms governing such manufacturing and supply relationships, and shall provide as follows: (a) Rhizen shall establish, by itself or through agreements with Third Parties, an appropriate manufacturing facility or contract manufacturer for the commercial Finished Product manufacture in a timely manner to ensure that Rhizen meets its obligation to supply quantities of Finished Product ordered by TGTX under the Commercial Supply Agreement. As further detailed in the Commercial Supply Agreement, upon the material and uncured breach by Rhizen of its defined supply obligations as set forth in the Commercial Supply Agreement, TGTX shall have the right to obtain transfer and Rhizen shall have the obligation to give transfer (the distribution of costs for such transfer to be determined by the parties) unless otherwise determined by JSC to TGTX, without undue delay, of any and all manufacturing technology necessary to enable it to manufacture or have manufactured Finished Product to meet its requirements under this Agreement. As further detailed in the Commercial Supply Agreement, if such transfer occurs, Rhizen would grant TGTX any additional licenses necessary to enable TGTX to exercise the foregoing manufacturing right but requiring TGTX to pay any additional consideration for such licenses. (b) Rhizen shall be responsible for the Finished Manufacture, testing (including stability testing) and final release of the Finished Product for Commercialization in the Territory. (c) The Parties each covenant and agree that all supply agreements executed regarding the provision of any product or material pursuant to this Agreement, shall contain customary representations and warranties regarding the manufacture of such products and materials, including, but not limited to, that all materials shall be manufactured, handled and stored: (i) in accordance with the agreed upon specification and (ii) in compliance with applicable Laws and regulations, including, without limitation, the GMP requirements.

Global Material & Supply Rights. Rhizen shall retain exclusive rights for manufacturing and supply of API and formulations for global development and commercializationcommercialization either as a JV entity or as a Licensor; provided however, that Rhizen’s price is cost competitive (as described in 5.2(b7.4(b)) and prior to the First Commercial Sale, the Parties shall timely negotiate in good faith and enter into a manufacturing and supply agreement. Such Commercial Supply Agreement shall contain customary terms governing such manufacturing and supply relationships, and shall provide as follows: (a) Rhizen shall establish, by itself or through agreements with Third Parties, an appropriate manufacturing facility or contract manufacturer for the commercial Finished Product manufacture in a timely manner to ensure that Rhizen meets its obligation to supply quantities of Finished Product ordered by TGTX under the Commercial Supply Agreement. As further detailed in the Commercial Supply Agreement, upon the material and uncured breach by Rhizen of its defined supply obligations as set forth in the Commercial Supply Agreement, TGTX shall have the right to obtain transfer and Rhizen shall have the obligation to give transfer (the distribution free of costs for such transfer to be determined by the parties) charge unless otherwise other wise determined by JSC to TGTX, without undue delay, of any and all manufacturing technology necessary to enable it to manufacture or have manufactured Finished Product to meet its requirements under this Agreementagrrement. As further detailed in the Commercial Supply Agreement, if such transfer occurs, Rhizen would grant grant, without prejudice to any other remedies that are available to TGTX, to TGTX any additional licenses necessary to enable TGTX to exercise the foregoing manufacturing right but without requiring TGTX to pay any additional consideration for such licenseslicenses unless otherwise determine by JSC. (b) Rhizen shall be responsible for the Finished Manufacture, testing (including stability testing) and final release of the Finished Product for Commercialization in the Territory. (c) The Parties each covenant . With regard to the Finished Product manufactured by or on behalf of Rhizen and agree that all supply agreements executed regarding used or sold for Commercialization in the provision Territory, the Manufacturing Cost incurred by Rhizen for the Finished Manufacture of any product the Finished Product thus used or material pursuant sold in the Territory hereunder, as well as the freight, postage, shipping, transportation, insurance, warehousing and handling charges actually allowed or paid by Rhizen with regard to this Agreement, shall contain customary representations and warranties regarding the manufacture of such products and materials, including, but not limited to, that all materials Finished Product shall be manufactured, handled and stored: (i) included in accordance with the agreed upon specification and (ii) Cost of Goods Sold in compliance with applicable Laws and regulations, including, without limitation, the GMP requirementscalculation of the Product Profit/Loss.