Promotional Materials and Activities. The Company shall be entitled to participate (through the JCC) in the planning of promotional materials and promotional activities with respect to the Products in the Territory. All promotional materials and promotional activities shall be developed by ERS, with input from the Company, following the general guidelines established by the JCC and consistent with the then current Marketing Plan applicable to the Products being promoted. Such activities may include symposia, key opinion leader events, and similar such events. Prior to finalizing such promotional materials and promotional activities, ERS shall include the Company in its internal circulation of information regarding such promotional materials and events during the development of such promotional materials and any event related materials and upon the finalization of such materials.
Promotional Materials and Activities. Kinex shall create and develop the advertising and promotional materials for the Licensed Products in the Territory with the written approval of Hanmi (which shall not be unreasonably withheld) with respect to all such materials. As holder of the Regulatory Approvals in the Territory, Kinex shall be responsible for all submissions and interactions with the Regulatory Authorities regarding approval of all Licensed Product-related promotional materials that require Regulatory Approval.
Promotional Materials and Activities. PharmaEssentia shall create and develop the advertising and promotional materials for the Licensed Products in the Territory with the written approval of Kinex (which shall not be unreasonably withheld). As the holder of the Regulatory Approvals in the Territory, PharmaEssentia shall be responsible for all submissions and interactions with the Regulatory Authorities regarding the Licensed Product-related promotional materials that require the Regulatory Approval.
Promotional Materials and Activities. Subject to the provisions of Section 3.02(b) below, Distributor shall be solely responsible, at its sole expense and under its sole control for conducting all promotional activities and for designing, preparing and distributing all materials, advertisements and activities used in the promotion, advertising and marketing of the Licensed Products within the Territory. Distributor shall Ensure that all materials, advertisements and promotional activities comply with, and Distributor shall be solely responsible and liable for any failure of such materials and activities to comply with, the applicable labeling and Licensed Product Registration for any of the Licensed Products and with Applicable Laws and regulations, notwithstanding any prior review or approval of such materials or activities by MPL and notwithstanding that such materials or activities may have been previously reviewed, used or conducted by MPL. Distributor shall be solely responsible for fulfilling regulatory requirements pertaining to its promotional materials and activities, including, without limitation, sole responsibility for submitting to FDA all promotional and advertising materials prepared by or for Distributor at the time of initial dissemination, by way of a Form FDA-2253, consistent with 21 CFR Part 314.81. To this effect, MPL shall, upon the Effective Date, or as soon thereafter as is reasonably practicable, place a letter on file with DDMAC with respect to the Licensed Products advising DDMAC that Distributor shall be the sole marketer and promoter of the Licensed Products in the Territory and requesting that DDMAC address regulatory inquiries and concerns regarding Distributor's promotional activities solely with Distributor. Distributor shall promptly, but in no event less than one (1) Business Day after Distributor's receipt thereof, provide a copy to MPL of any correspondence from a government agency with respect to any of the Licensed Products, including, but not limited to, the FDA, reflecting any purported legal or regulatory violations or legal or regulatory action being considered or taken by such government agency, including without limitation, copies of FDA NOV's and Warning Letters. Unless otherwise required, Distributor shall not provide MPL with copies of any promotional materials or advertising or notify MPL of any promotional activities unless pursuant to a written request by MPL. Distributor shall absorb and be solely responsible for any and all lost profits, los...
Promotional Materials and Activities. XPH shall create and develop the advertising and promotional materials for the Licensed Products in the Territory with the written approval of Kinex (which shall not be unreasonably withheld) with respect to all such materials. As holder of the Regulatory Approvals in the Territory, XPH shall be responsible for all submissions and interactions with the Regulatory Authorities regarding approval of all Licensed Product-related promotional materials that require Regulatory Approval.
Promotional Materials and Activities. Teva shall create and develop all appropriate promotional materials and Labeling for the Licensed Products. Teva shall be responsible for all submissions and interactions with Regulatory Authorities regarding Licensed Product-related promotional materials and Labels that are required to be submitted to Regulatory Authorities.
Promotional Materials and Activities. DURECT shall be entitled to participate (through the JCC meetings) in the review of future promotional materials and promotional activities with respect to the Product, Finished Product and Implanters in the Territory. All promotional materials and promotional activities shall be developed by Endo, with input from DURECT through the JCC process, following the general guidelines established by the JCC and consistent with the then current Marketing Plan.
Promotional Materials and Activities. Licensee shall be responsible, at its sole expense, for preparing all Promotional Materials used to support the Commercialization of the Licensed Product in the Field in the Territory. All Promotional Materials shall be consistent with Applicable Law and with the Product Labeling approved by Licensee for the Licensed Product. Licensee shall be responsible for obtaining any approvals from the Regulatory Authorities required for the use of any Promotional Materials in the Field in the Territory and shall submit all applicable Promotional Materials to such Regulatory Authorities as required by Applicable Law.
Promotional Materials and Activities. During the Copromotion Period, and in compliance with Law, Esprit shall have the sole right to create and develop the Promotional Materials with, during the Copromotion Period, input and participation from the Marketing Committee, subject to Section 5.6(a). During the Copromotion Period, prior to Confidential treatment has been requested for portions of this document. This copy of the document filed as an Exhibit omits the confidential information subject to the confidentiality request. Omissions are designated by the symbol [...***...]. A complete version of this document has been provided separately to the Securities and Exchange Commission. finalizing such Promotional Materials and promotional activities, each Party shall include the other Party in its internal circulation of information regarding such promotional materials and activities during the development of such Promotional Materials and any event related materials and upon the finalization of such materials.
Promotional Materials and Activities. Subject to the terms of this Section 5.4, during the Detail Requirements Period, and in compliance with applicable Law, the Marketing Committee shall create and develop, subject to approval by the Steering Committee of the Promotion Plan, the Promotional Materials with input and participation from both Parties, following the general guidelines established by the Marketing Committee and consistent with the then current Promotion Plan. After expiration of the Detail Requirements Period, the Marketing Committee shall create and develop, subject to review by the Steering Committee of the Promotion Plan, the Promotional Materials as described in the foregoing sentence. Promotional activities may include programs sponsored and controlled by a Party to disseminate or obtain information relating to Product. During the Detail Requirements Period, prior to finalizing such Promotional Materials and promotional activities, each Party shall include the other Party in its internal circulation of information regarding such promotional materials and activities during the [*] CONFIDENTIAL TREATMENT REQUESTED development of such Promotional Materials and any event related materials and upon the finalization of such materials.
