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. 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. 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. 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 the promotional materials for the Products. As holder of the Regulatory Approvals for Product in the Territory, Teva shall be responsible for all submissions and interactions with the Regulatory Authorities regarding approval of all Product-related promotional materials that require Regulatory Approval.
Promotional Materials and Activities. DURECT shall be presented with [* * *] NYCOMED’s planned promotional materials and promotional activities with respect to the Product in the Territory. All promotional materials and promotional activities shall be developed by NYCOMED consistent with the then current Marketing Plan. To the extent commercially feasible and permitted by laws and regulations, all promotional materials shall include an acknowledgment of DURECT as the developer and licensor of the Product.
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 Athenex (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 and the costs therefor. SUPPLY TERM SHEET Overview: Manufacturing efforts for the Licensed Products shall be the responsibility of XPH. Athenex shall provide assistance and support, including in the negotiations for lands or other commercial arrangements within or, the establishment of the joint venture [*], (subject to complying with the relevant confidentiality agreement), the provision of the contracts of and the architectural blueprints of for XPH’s reference. XPH can consider outsourcing manufacturing to CMOs in case of resource constraints.
Promotional Materials and Activities. Almirall shall create and develop the advertising and promotional materials for Licensed Products in the Field in the Territory. As holder of the Regulatory Approvals in the Territory, Almirall or Aqua, as applicable, shall (and shall ensure that their Affiliates and Sublicensees shall) be responsible for all submissions and interactions with the Regulatory Authorities regarding approval of all Licensed Product-related promotional materials in the Field in the Territory that require Regulatory Approval. Almirall or Aqua, as applicable, may consult with Athenex with a view to ensuring that such materials are consistent with U.S. market best practices and comply with regulatory requirements.
