Labeling and Promotional Materials. All Licensed Product packages will comply with all patent marking requirements as specified in 35 USC Sec. 287.
Labeling and Promotional Materials. On and following the Marketed Products Closing:
(a) Hyperion shall have the sole authority and responsibility for the development, use and approval of Promotional Materials for the Transferred Marketed Products and, for clarity, Ucyclyd shall not have any rights of review or approval; and
(b) Hyperion shall have the sole authority and responsibility to seek and obtain any necessary FDA approvals of any label, labeling, package inserts and packaging, and Promotional Materials used in connection with the Transferred Marketed Products and for determining whether the same requires FDA submission or approval.
Labeling and Promotional Materials. Subject to applicable laws and regulations, labeling on all Products and Services sold by or on behalf of Xxxxxxx, its Affiliates, or Sublicensees pursuant to this Agreement and on all package inserts will identify Biogen Idec as licensor of the Biogen Idec Patents and will comply with all patent marking requirements as specified in 35 USC § 287. *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Labeling and Promotional Materials. ViroPharma shall be solely responsible for obtaining any approval from a Regulatory Authority of any label, labeling, package inserts, packaging, and Promotional Materials used in connection with VP Product, and for determining whether the same requires approval from a Regulatory Authority. ViroPharma shall use commercially reasonable efforts to establish and maintain the resources to perform its duties under this Section 7.3. As permitted by applicable Laws, ViroPharma and Aventis shall be given equal exposure and prominence on all VP Product labels, labeling, package inserts, packaging, and Promotional Materials used or distributed in connection with VP Product under this Agreement; except that either Party may request that its name not be used, to the extent permitted by applicable Laws. As permitted by applicable Laws, the Parties shall attempt to have the appearance of VP Product labels, labeling, package inserts, packaging, and Promotional Materials used or distributed in connection with VP Product under this Agreement conform with the guidelines and requirements of each Party. Each package or label of VP Product shall bear the statement "Under license from SANOFI-SYNTHELABO", or such other statement that SaSy may reasonably request, including, without limitation, references to patent numbers, provided that such wording otherwise complies with all Laws applicable to such labeling. ViroPharma shall use commercially reasonable efforts to ensure that any markings requested by SaSy to appear on the label or packaging of VP Products are reasonable, and are consistent with the decisions made by the MSC or the JSC regarding such packaging or labeling.
Labeling and Promotional Materials. XXXXXX-XXXXXXX shall have sole authority and responsibility to seek and/or obtain any necessary Governmental or Regulatory Authority approvals of any label, labeling, package inserts, Product monographs and packaging, and Promotional Materials used in connection with the Products, and for determining whether the same requires Governmental or Regulatory Authority approval. No Product label, labeling or Promotional Materials may be used or distributed by PFIZER unless such label, labeling or Promotional Materials have been approved in advance by the Country Marketing Team and, for purposes of determining compliance with applicable Laws, XXXXXX- XXXXXXX, pursuant to XXXXXX-XXXXXXX'x internal procedures.
Labeling and Promotional Materials. (a) Pfizer and its Affiliates shall have the sole authority and responsibility to seek and/or obtain any necessary FDA approvals of any label, labeling, package inserts and packaging used in connection with the Product, and for determining whether the same requires FDA approval.
(b) Following NDA Approval, Distributor shall be solely responsible for submission of all Promotional Materials as required by Law to DDMAC, including, but not limited to, submission of each Form 2253 to the FDA. In addition, Distributor agrees to seek pre-clearance from DDMAC with respect to all Promotional Materials to be used on launch of the Product. Distributor will be the designated recipient of all DDMAC correspondence, and agrees to be solely responsible for responding to, and complying with, all FDA inquiries, Notices of Violation, Warning Letters and other actions of FDA related to promotional activities. In addition, Distributor will immediately notify Pfizer of any Proceedings (threatened or pending), involving potential or actual violations of Law by Distributor related to the Product. Except with respect to the Form 2253, Distributor agrees that it will promptly provide to Pfizer copies of all submissions to and correspondence to and from the FDA and any Proceedings related to the Product pursuant to this Section, and Pfizer shall have the right, but not the obligation, to comment on such submissions and correspondence, and Distributor shall make such changes to any such communications and submissions to the FDA and take such actions in respect thereof as may be reasonably requested by Pfizer.
(c) Following execution of this Agreement, Pfizer shall continue to own the NDA, and will use its Commercially Reasonable Efforts to obtain NDA Approval. Pfizer may file, but shall not be required to file, any additional New Drug Applications or supplemental New Drug Applications with respect to the Product. Pfizer agrees that it will provide to Distributor copies of correspondence to and from the FDA related to the Product, except to the extent such correspondence relates to any proprietary manufacturing data.
Labeling and Promotional Materials. Subject to applicable laws and regulations, packaging for all Products sold by or on behalf of Licensee, its Affiliates, or Sublicensees pursuant to this Agreement and on all package inserts and labeling will identify SDP (or its successor assign) as licensor of the ADVENTRX Patents and will comply with all patent marking requirements as specified in 35 USC Sec. 287 or other applicable patent marking requirements of other jurisdictions to preserve and maximize the rights and remedies of SDP and ADVENTRX.
Labeling and Promotional Materials. Notwithstanding the provisions of Section 8.03 of the Agreement, Pfizer shall have authority and responsibility to seek and/or obtain any necessary Governmental or Regulatory Authority approvals of any label, labeling, package inserts, Product monographs and Packaging, on Promotional Materials used in connection with the Products, and for determining whether the same requires Governmental or Regulatory Authority approval; provided, however, that no such labels, labeling, package inserts, Product monographs and packaging, and Promotional Materials may used or distributed by Pfizer unless the same shall be approved in advance by the China Country Marketing Team and, for the purposes of determining compliance with applicable laws, Xxxxxx-Xxxxxxx, pursuant to Xxxxxx- Xxxxxxx'x internal procedures.
Labeling and Promotional Materials. XXXXXX-XXXXXXX shall have sole authority and responsibility to seek and/or obtain any necessary FDA approvals of any label, labeling, package inserts and packaging, and Promotional Materials used in connection with the Products, and for determining whether the same requires FDA approval. No Product label, labeling or Promotional Materials may be used or distributed by PFIZER unless such label, labeling or Promotional Materials have been approved in advance by the Operating Committee (or the U.S. Marketing Subcommittee thereof) and, for purposes of determining compliance with applicable Laws, XXXXXX-XXXXXXX, pursuant to XXXXXX-XXXXXXX'x internal procedures.
Labeling and Promotional Materials
