SCD Products definition
Examples of SCD Products in a sentence
Subject to the terms of this Agreement, NVS hereby grants to HMI during the Term of this Agreement, a worldwide exclusive license without the right to sublicense under the NVS Program Patent Rights, the NVS Program Know-How, and NVS’ interest in the Joint Know-How and Joint Patent Rights, in each case, to Commercialize In-Vivo SCD Products in the U.S.
NVS will prepare a reasonably detailed, annual plan for global Medical Affairs with respect to In-Vivo SCD Products (the “Global Medical Affairs Plan”), and HMI will prepare a reasonably detailed, annual plan for Medical Affairs with respect to In-Vivo SCD Products in the U.S. (the “U.S. Medical Affairs Plan”), in each case, no later than [***] or an In-Vivo SCD Product.
HMI will be responsible for Medical Affairs with respect to In-Vivo SCD Products in the U.S., and will conduct such activities in accordance with the U.S. Medical Affairs Plan; and NVS will be responsible for Medical Affairs with respect to In-Vivo SCD Products outside of the U.S., and will conduct such activities in accordance with the Global Medical Affairs Plan.
Subject to Section 7.6 (Transfer of U.S. BLA for In-Vivo SCD Products), all Regulatory Approvals and Pricing Approvals for Products will be [***] owned by [***].
Upon HMI’s reasonable request, NVS will provide to HMI samples of NVS’ core promotional materials for In-Vivo SCD Products outside the U.S.
Each In-Vivo Sickle Cell Development Milestone Payment shall be payable only once upon the first occurrence of the applicable In-Vivo Sickle Cell Development Milestone Event, and none of the In-Vivo Sickle Cell Development Milestone Payments shall be payable more than once, regardless of the number of In-Vivo SCD Products Developed or Commercialized.
For all recalls of In-Vivo SCD Products, the Parties will reasonably consult with each other with respect to the actions to be taken to address such recall, market withdrawal, or stock recovery, [***], and [***].
If the Parties are unable to agree upon the terms of the In-Vivo SCD Commercial Supply Agreement, then neither Party will be obligated to enter into such agreement, and NVS will not be obligated to Manufacture In-Vivo SCD Products under the In-Vivo SCD Commercial Supply Agreement until the Parties reach agreement on the terms of such agreement.
The Parties will [***] agree on the content of each Jointly-Agreed Regulatory Submissions for In-Vivo SCD Products excluding any portion of any such submission that relates solely to any data or information relating to any Other Components.
At least [***] In-Vivo SCD Product, the Parties’ regulatory teams will meet and agree on the strategy and procedures for reviewing, approving, and submitting Jointly-Agreed Regulatory Submissions for In-Vivo SCD Products.