Examples of Marketing Approvals in a sentence
Genentech shall own all regulatory submissions, including all Marketing Approvals and applications therefor, for Licensed Products in the United States.
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 own and maintain all regulatory filings and Marketing Approvals in the Territory for POZEN Products, including all INDs and NDAs for the Initial POZEN Product.
In the event that such a transfer is not possible, Indivior shall use reasonable endeavors to provide Addex with the benefit of the existing Marketing Approvals and applications therefor for Products, including, without limitation, granting Addex and/or its designees rights to cross-refer to the data and information on file with Regulatory Authorities as may be necessary to facilitate the granting of separate Marketing Approvals to Addex.
Licensee shall have the sole authority and responsibility to obtain in its own name and maintain any Regulatory Approvals and Marketing Approvals with respect to the Licensed Product in the Territory.
Unless otherwise mutually agreed to by the Parties, Elpiscience shall not license or authorize, under any rights owned, controlled or licensed to Elpiscience, including any rights in or to any regulatory filings, Marketing Approvals or granted by a Regulatory Authority, a Third Party to develop, market or sell a Generic Product.
To the extent required by applicable Laws, including regulations promulgated by applicable securities exchange, each Party shall have the right to make a press release announcing the achievement of each milestone under this Agreement as it is achieved, and the achievements of Marketing Approvals in the Territory as they occur, subject only to the review procedure set forth in the preceding sentence.
For clarity, Licensee shall own all Marketing Approvals and Regulatory Materials pertaining to Products in the Territory.
During the Post-Exercise Term, Arsanis (itself or with or through its Affiliates or Licensees) shall be solely responsible for preparing and submitting all INDs, NDAs and other regulatory filings for Licensed Antibodies and Products in the Field (collectively, “Arsanis Regulatory Filings”), and for obtaining and maintaining all Marketing Approvals for Products in the Field (“Arsanis Approvals”), at Arsanis’ sole expense.
The foregoing notwithstanding, to the extent that Schering-Plough holds the market authorizations and Marketing Approvals in a country in the Territory, Schering-Plough shall have primary responsibility for such communications, and will do so in collaboration with Centocor, with Centocor having the right to have representatives present at any meetings with regulatory agencies in such countries concerning the Product.