Treatment Regimen definition

Treatment Regimen is defined in Section 5.2(b).
Treatment Regimen means administration of a Licensed Product as a single agent, or in combination with one or more approved pharmacological, anti-tumor agents, in each case, regardless of dosing, formulation and route of administration. For purposes of Milestone Events [ * ], the Treatment Regimen used in the (subsequent) clinical trial/approval differs from the Treatment Regimen used in the (prior) clinical trial/approval, if (A) at least one chemotherapy agent used in the Treatment Regimen in such (subsequent) clinical trial/approval acts through a different mechanism of action than each and every one of the chemotherapy agents used in the Treatment Regimen in such (prior) clinical trial/approval or (B) the Licensed Product is used/approved as a single agent in such (subsequent) clinical trial/approval or was so used/approved in such (prior) clinical trial/approval, but not in both. By way of example, but not limitation, [ * ] and [ * ] act through the same mechanism of action, whereas [ * ] and [ * ] act through different mechanisms of action.

Examples of Treatment Regimen in a sentence

  • Sanofi shall have rights to use, at no additional cost, any RevMed Study Data in its performance of its obligations and exercise of its rights under the Collaboration except in connection with filing of ▇▇▇▇ for the Indication and Product Treatment Regimen that were the subject of such RevMed Study.

  • If Sanofi wishes to use, or actually uses, RevMed Study Data in support of filing a MAA for the Indication and Product Treatment Regimen that were the subject of such RevMed Study, it shall notify RevMed in writing and shall make a buy-in payment to RevMed in Dollars equal to [***] within [***] after the date that Sanofi receives a detailed invoice from RevMed setting forth [***].

  • The parties acknowledge that the Ohio State University Research Foundation ("OSURF") has granted each party their respective rights, pursuant to certain agreements and conditions, in the intellectual property, which the parties desire to contribute to the development of the Treatment Regimen.

  • Cira ▇▇▇ll utilize Neoprobe's Intellectual Property and technical information in conjunction with Cira'▇ ▇▇▇ellectual Property and technical information to develop the Treatment Regimen.

  • Except for the Initial Direct Costs, each party shall be responsible for all of its own costs and expenses incurred in connection with the development of the Treatment Regimen.

  • Cira ▇▇▇ees to protect the Confidential Information to the same extent and in the same manner that it would protect its own confidential information, but in no event will such efforts fall below a level of reasonable care, which shall include limiting disclosure to only those personnel who have a need to know for the purposes of developing the 3 Treatment Regimen.

  • The parties agree to maintain their respective agreements in good standing with OSURF and to notify the other party in the event of a termination or any material change in said agreements, which could adversely affect the marketability of the Treatment Regimen.

  • Upon development of the Treatment Regimen, the Parties shall endeavor to identify a third party to license the Treatment Regimen on mutually agreeable terms and conditions.

  • If Sanofi wishes to use or actually uses, RMC-4630-03 Study Data in support of filing a MAA for the Indication and Product Treatment Regimen that were the subject of RMC-4630-03, it shall notify RevMed in writing and shall make a buy-in payment to RevMed in Dollars equal to [***], such payment to be made within [***] after the date that Sanofi receives an invoice from RevMed setting forth such amount.

  • Confidential Information may only be disclosed to Cira'▇ ▇▇▇loyees and, even then, only to the extent that such employees have a specific need to know of the Confidential Information for the purpose of developing the Treatment Regimen.