Examples of Sobi Territory in a sentence
Halte Besar BSD – Halte Al-Azhar – Halte Pemasaran BSD – Jl. Serpong Raya – Tol Tangerang Kebon Jeruk – Jl. Tomang Raya – Jl. Kyai Caringin – Jl. Balikpapan – Jl. Suryo Pranoto – Halte Busway Harmoni Jl. Juanda – Jl. Juanda – Halte Pasar Baru (Gedung Kesenian Jakarta) – Jl. Veteran – Halte Harmoni lampu merah Suryo Pranoto – Jl. Tomang Raya – Tol Jakarta Tangerang 55Tel.
In furtherance of the foregoing, each Party may, prior to Opt-In for a Product, present to the JSC Commercialization and other activities that are not subject to the Parties’ then-existing obligations hereunder concerning Development or Final Development, but which it believes are likely to be of material benefit to the Product profile in both the Biogen Idec Territory and the Sobi Territory.
In addition, Sobi is solely responsible for costs associated with obtaining and maintaining regulatory approval for XIAPEX in the Sobi Territory as well as post-regulatory approval filing date development activities.
The Company is responsible for all clinical and commercial manufacturing and supply of XIAPEX for the Sobi Territory.
Biogen Idec and Sobi shall establish a plan for the commercial launch of each Lead Product during the MAH Transition Period for EMA in certain of the EMA Centralized Approval Countries with Biogen Idec as the MAH and Sobi having the exclusive right to sell and distribute such Product in the Sobi Territory pursuant to a distribution agreement to be negotiated in good faith by the Parties and executed no later than six (6) months after the exercise of the Opt-In Right by Sobi.
Following the Opt-In for a Lead Product and receipt of FDA’s approval of the Regulatory Filing for such Lead Product, if either Party receives a request from a medical practitioner for Named Patient Supply in the Sobi Territory for such Lead Product, such Party shall notify the other Party.
Biogen Idec’s reasonable out-of-pocket expenses (including all costs of outside counsel) for preparing, filing, prosecuting (including any interferences, oppositions, reissue proceedings and reexaminations) and maintaining such patent applications and patents in such countries (other than the Core Countries) in the Sobi Territory requested by Sobi shall be reimbursed by Sobi.
In furtherance of the foregoing, each Party may, following Opt-In, present to the JCC or JMDC, as appropriate, Commercialization activities or other activities that are not subject to the Parties’ then-existing obligations hereunder concerning Development or Final Development, but which it believes are likely to be of material benefit to the Product profile in both the Biogen Idec Territory and the Sobi Territory.
Sobi shall reimburse Biogen Idec for the expenses associated with Biogen Idec’s activities to prepare, operate, submit select safety reports, generate aggregate reports from, and manage the Global Safety Database that benefit the Sobi Territory, and to process safety events, and, until MAH transfer, perform QPPV and pharmacovigilance activities, in the Sobi Territory, to the extent such activities are set forth in the Safety Data Exchange Agreement, as it may be amended.
For the time period between Biogen Idec’s First Commercial Sale of such Lead Product in the Biogen Idec Territory and Sobi’s First Commercial Sale of such Lead Product in the Sobi Territory, Biogen Idec would initially make quarterly cash payments of 2% of Net Sales in the Biogen Idec North America Territory and the Biogen Idec Direct Territory and 10% of Biogen Idec’s Net Partner Revenues in the Biogen Idec Partner Territory.