Examples of POZEN Product in a sentence
If a Regulatory Authority in the Territory desires to conduct an inspection or audit of a Party’s facility, or a facility under contract with a Party, with regard to a POZEN Product, then such Party will promptly notify the other Party and permit and cooperate with such inspection or audit, and will cause the contract facility to permit and cooperate with such Regulatory Authority and such other Party during such inspection or audit.
POZEN, at its sole discretion, may redact the protocols submitted to Nycomed to avoid disclosure of the identity of the specific POZEN Product to which such studies relate.
Each Party will consult with the other Party regarding (and provide copies of materials prior to any submission to a Regulatory Authority and materials after receipt from a Regulatory Authority), and keep such other Party reasonably and regularly informed of, the status of the preparation of all Regulatory Materials in the Territory, review of such materials by the relevant Regulatory Authority in the Territory, and Marketing Approvals received for the Initial POZEN Product in the Territory.
Licensee will be responsible at Licensee’s expense, but other than as set forth in this Agreement, shall not be obligated to, prepare and file INDs and NDAs and seek NDA Approvals for the Initial POZEN Product in all countries in the Territory, including preparing all reports necessary as part of any such IND or NDA.
Licensee will have the right to Develop and Commercialize Products during the Term in the Territory, for so long as Licensee is using Diligent Efforts to Commercialize at least one POZEN Product in accordance with this Section 5.3, it being understood that the Parties intend for Licensee to focus its initial efforts on the Commercialization of the Initial POZEN Product in the Territory.
The product director designated by Licensee for the Initial POZEN Product will chair the PT (“PT Chair”).
POZEN will notify Nycomed in writing of the expiration date of any POZEN Product and of any changes thereto.
To the extent permitted by Applicable Law, Licensee shall transfer and assign to POZEN all Regulatory Materials and Marketing Approvals that are Controlled by Licensee for Commercialized POZEN Product in the Territory.
To the extent required or permitted by Applicable Law, Licensee will use Diligent Efforts to promptly list and maintain with the applicable ***Confidential Treatment Requested -26- Regulatory Authorities in the Territory during the Term correct and complete listings of applicable Licensed Patents for such POZEN Product, including all so called “Orange Book” listings required under the Xxxxx-Xxxxxx Act.
However, Licensee shall not be required to Develop or Commercialize a POZEN Product in a particular Major Ex-U.S. Market country if it is not commercially reasonable to do so consistent with the exercise of Diligent Efforts and, upon POZEN’s request, will provide POZEN data supporting such determination.