Common use of Regulatory Matters; EpiCept Assistance Clause in Contracts

Regulatory Matters; EpiCept Assistance. All Regulatory Approvals with respect to the Endo BP Product in the Territory shall be in Endo's or Endo's designee's name. Endo shall have exclusive control over, and authority and responsibility for, the regulatory strategies relating to the development and commercialization of the Endo BP Product in the Territory, including, without limitation: (a) the preparation of all documents submitted to Regulatory Authorities and the filing of all submissions relating to Regulatory Approval for the Endo BP Product; and (b) all regulatory actions, communications and meetings with any Regulatory Authority with respect to the Endo BP Product. Upon the request of Endo, EpiCept shall provide to Endo on a timely basis such information in its possession relating to the LidoPAIN(R) BP Product as may be required for regulatory activities related to the commercialization of the LidoPAIN(R) BP Product, and otherwise provide reasonable assistance to Endo in complying with all regulatory obligations in the Territory, including without limitation, safety updates, amendments, annual reports, pharmacovigilance filings, investigator notifications, manufacturing facility inspections and certifications and product approvals. Endo shall be responsible for interfacing, corresponding and meeting with all Regulatory Authorities in the Territory with respect to the Endo BP Product and, after Regulatory Approval has been obtained, the LidoPAIN(R) BP Product. EpiCept shall cooperate with Endo to provide all reasonable assistance and take all actions reasonably requested by Endo that are necessary to comply with any law applicable to any Licensed Product, including, but not limited to, reporting of adverse drug experience reports (and serious adverse drug experiences) to Regulatory Authorities in the Territory.

Regulatory Matters; EpiCept Assistance. All Regulatory Approvals with respect to the Endo BP Product Licensed Products in the Territory shall be in Endo's or Endo's designee's Adolor’s name. Endo Adolor shall have exclusive control over, and authority and responsibility for, the regulatory strategies relating to the development and commercialization of the Endo BP Product all Licensed Products in the Territory, including, without limitation: (a) the preparation of all documents submitted to Regulatory Authorities and the filing of all submissions relating to Regulatory Approval for the Endo BP ProductLicensed Products; and (b) all regulatory actions, communications and meetings with any Regulatory Authority with respect to the Endo BP any Licensed Product. Upon the request of EndoAdolor, EpiCept shall provide to Endo Adolor on a timely basis such information in its possession relating to the LidoPAIN(R) BP LidoPAIN® SP Product and any other Licensed Product as may be required for the foregoing regulatory activities related to the commercialization of the LidoPAIN(R) BP Productactivities, and otherwise provide reasonable assistance to Endo Adolor in complying with all regulatory obligations in the Territory, including without limitation, safety updates, amendments, annual reports, pharmacovigilance filings, investigator notifications, manufacturing facility inspections and certifications and product approvals. Endo Except as required by Section 3.1(d), Adolor shall reimburse EpiCept for the out-of-pocket costs and expenses incurred by EpiCept in complying with such request. Adolor shall be responsible for interfacing, corresponding and meeting with all Regulatory Authorities in the Territory with respect to any Licensed Product. Except as required by applicable law, EpiCept shall not communicate directly with the Endo BP FDA or any other Regulatory Authority in the Territory relating to the LidoPAIN® SP Product andor any other Licensed Product without the prior written consent of Adolor. In furtherance thereof, after Regulatory Approval has been obtained, the LidoPAIN(R) BP ProductEpiCept shall refer all FDA communications relating to any Licensed Product to Adolor. EpiCept shall cooperate with Endo Adolor to provide all reasonable assistance and take all actions reasonably requested by Endo Adolor that are necessary to comply with any law applicable to any Licensed Product, including, but not limited to, reporting of adverse drug experience reports (and serious adverse drug experiences) to Regulatory Authorities in the Territory.

Regulatory Matters; EpiCept Assistance. All Regulatory Approvals with respect to the Endo BP Product Licensed Products in the Territory shall be in Endo's or Endo's designeeAdolor's name. Endo Adolor shall have exclusive control over, and authority and responsibility for, the regulatory strategies relating to the development and commercialization of the Endo BP Product all Licensed Products in the Territory, including, without limitation: (a) the preparation of all documents submitted to Regulatory Authorities and the filing of all submissions relating to Regulatory Approval for the Endo BP ProductLicensed Products; and (b) all regulatory actions, communications and meetings with any Regulatory Authority with respect to the Endo BP any Licensed Product. Upon the request of EndoAdolor, EpiCept shall provide to Endo Adolor on a timely basis such information in its possession relating to the LidoPAIN(R) BP SP Product and any other Licensed Product as may be required for the foregoing regulatory activities related to the commercialization of the LidoPAIN(R) BP Productactivities, and otherwise provide reasonable assistance to Endo Adolor in complying with all regulatory obligations in the Territory, including without limitation, safety updates, amendments, annual reports, pharmacovigilance filings, investigator notifications, manufacturing facility inspections and certifications and product approvals. Endo Except as required by Section 3.1(d), Adolor shall reimburse EpiCept for the out-of-pocket costs and expenses incurred by EpiCept in complying with such request. Adolor shall be responsible for interfacing, corresponding and meeting with all Regulatory Authorities in the Territory with respect to any Licensed Product. Except as required by applicable law, EpiCept shall not communicate directly with the Endo BP Product and, after FDA or any other Regulatory Approval has been obtained, Authority in the Territory relating to the LidoPAIN(R) BP ProductSP Product or any other Licensed Product without the prior written consent of Adolor. In furtherance thereof, EpiCept shall refer all FDA communications relating to any Licensed Product to Adolor. EpiCept shall cooperate with Endo Adolor to provide all reasonable assistance and take all actions reasonably requested by Endo Adolor that are necessary to comply with any law applicable to any Licensed Product, including, but not limited to, reporting of adverse drug experience reports (and serious adverse drug experiences) to Regulatory Authorities in the Territory.