Interim Responsibility Clause Samples
Interim Responsibility. Notwithstanding this Article VIII, but subject to completion of the transition of ** supply to Baxalta pursuant to Section 8.1.2.1, unless and until the ** is executed and/or Baxalta contracts for the supply of Manufactured Products (defined in Section 8.2) through Independent Suppliers (as defined in Section 8.7) pursuant to Section 8.7, CTI shall be solely responsible and obligated to supply Licensed Product to Baxalta at a price equal to **.
Interim Responsibility. Until the transfer of sponsorship of the TAK- 580 IND to Day One is effective, Takeda shall be solely responsible for maintaining the TAK-580 IND and Takeda shall have responsibility for all communications with the FDA and all other Regulatory Authorities relating to the Compound and the Products, and Takeda will consult with Day One regarding all such communications and shall promptly provide Day One with copies of all communications to or from any Regulatory Authority with respect to the Compound or any Product, including the Manufacture thereof; provided that for so long as Takeda remains responsible for the TAK-580 IND, Takeda shall be responsible for preparing all Regulatory Submissions that are due for submission to any Regulatory Authority within such period in accordance with the Transfer Plan. Takeda shall promptly provide Day One with copies of any communications or contacts it sends to or receives from any other Governmental Authority concerning the Compound or any Product. Upon the transfer of sponsorship of the TAK-580 IND, Day One shall assume responsibility for maintaining the TAK-580 IND and for all communications with the FDA and all other Regulatory Authorities relating to the Compound and the Products, subject to Takeda’s rights under Section 4.8(c).