Fixed Dose Combination Product. With respect to Fixed Dose Combination Products, on a Fixed Dose Combination Product-by-Fixed Dose Combination Product and country-by-country basis during the Royalty Term applicable to such Fixed Dose Combination Product and such country, Lilly shall pay Licensee a [***] royalty on Net Sales of such Fixed Dose Combination Product.
Fixed Dose Combination Product. If Lilly decides, in its sole discretion, to pursue the Development or Commercialization of a Fixed Dose Combination Product, the Parties shall discuss in good faith and enter into a mutually acceptable supply agreement (the “Supply Agreement”) to govern the supply of Commercialization Product and the Compound used in such Commercialization Product and a related quality agreement (the “Quality Agreement”) to govern the responsibilities and procedures associated with record retention, complaint handling, quality-specific audit rights, specifications, key contacts and other quality-related matters. Additionally, Lilly shall have the right to audit all nodes of Licensee’s supply chain, including Third Party manufacturing sites, prior to entering into, and during the term of, the Supply Agreement. Lilly shall have sole responsibility for the Manufacture of any Lilly Target Molecules prescribed for use in Lilly Product. To the extent that Lilly notifies Licensee in writing that it desires to establish an alternative source of supply for Fixed-Dose Combination Products: (a) to the extent that the Fixed-Dose Combination Product includes a Commercialization Product, Lilly shall be permitted to establish such alternative source of supply of a finished dosage form containing the applicable Compound (but not the Compound itself), and (b) to the extent that the Fixed-Dose Combination Product does not include a Commercialization Product, Lilly shall be permitted to establish such alternative source of supply for the Compound and the finished dosage form containing the Compound; provided, that notwithstanding clauses (a) and (b) if Lilly reasonably determines based on its audit of Licensee’s supply chain discussed above that there are quality issues with the Compound, Lilly shall be permitted to establish an alternative source of supply for the Compound and the finished dosage form containing the Compound for any Fixed-Dose Combination Product.
Fixed Dose Combination Product. Seagen may perform pre-clinical research on a RC48 Fixed Dose Combination Product [ * ] for the RC48 Fixed Dose Combination Product, [ * ]. When Seagen is ready to [ * ] with respect to an RC48 Fixed Dose Combination Product, Seagen shall [ * ] so notify RemeGen in writing and provide a package containing [ * ]. RemeGen shall have [ * ] to review such package. At the end of the [ * ] period, the Parties shall [ * ] in good faith over a [ * ] period commercially reasonable [ * ] terms [ * ] for such RC48 Fixed Dose Combination Product, which [ * ] terms shall be [ * ]; provided that if RemeGen notifies Seagen within such [ * ] period that it does not wish to clinically Develop and Commercialize the RC48 Fixed Dose Combination Product in the RemeGen Territory, then [ * ]. If the Parties do not agree within such [ * ] period (as may be extended by agreement of the Parties) on the [ * ] terms for such RC48 Fixed Dose Combination Product, then the matter [ * ]. For clarity, (i) Seagen’s right to Develop and Commercialize any RC48 Fixed Dose Combination Product is expressly conditioned on the [ * ] terms for such RC48 Fixed Dose Combination Product having been determined in accordance with this Section 2.7(d), (ii) without limiting the foregoing clause (i), Seagen agrees to [ * ], and (iii) [ * ]. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
