Examples of SCD Products in a sentence
During the Term, so long as HMI is the Commercializing Party for the U.S. SCD Products and subject to Article 8 (Manufacturing and Technology Transfer), HMI will be solely responsible, at its cost and expense, for Commercializing all In-Vivo SCD Products in the U.S. (including booking all sales for such In-Vivo SCD Products in the U.S.).
The Parties will cooperate with regard to the reporting and handling of safety information, including Adverse Events, involving In-Vivo SCD Products in accordance with Applicable Law on pharmacovigilance and clinical safety.
Upon either Party’s reasonable request, but subject to local anti-competition laws and any obligations of confidentiality between a Party and any Third Party, the Parties will share key market research and relevant sections of national reimbursement dossiers (or their equivalent) for In-Vivo SCD Products, as well as other relevant Commercialization information as may be agreed by the Parties.
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.
The transfer price paid by HMI for In-Vivo SCD Products under the In-Vivo SCD Commercial Supply Agreement shall be equal to [***].
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 [***].
In conjunction with the Royalty Reports, NVS will notify HMI [***] after the end of each Calendar Quarter in which the date on which NVS’, its Affiliates’, and its Sublicensees’ cumulative Net Sales of all In-Vivo SCD Products in all countries in the Territory other than the U.S. in a given Calendar Year first reach the respective thresholds indicated below in Table 11.5.3 below (each, an “In-Vivo Sickle Cell Sales Milestone Event”).
Subject to the terms of this Agreement, effective as of the SCD Opt-Out Date, HMI hereby grants to NVS and its Affiliates an exclusive license (with the right to grant sublicenses through multiple tiers in accordance with Section 4.3 (Sublicensing Rights)) under the HMI Licensed Technology to Commercialize U.S. SCD Products.