Collaboration Product definition
Examples of Collaboration Product in a sentence
Neither Freenome nor any of its Affiliates has received any written notice or threat in writing from any Person (including any invitation to license) asserting or alleging that any Development, Manufacture or Commercialization of any Collaboration Product by Freenome or its Affiliates has infringed, misappropriated or otherwise violated, will infringe, misappropriate or otherwise violate, or currently infringes, misappropriates or otherwise violates, any intellectual property rights of such Person.
For the avoidance of doubt, an MCED Product is not a Collaboration Product.
Except as otherwise provided herein, the PMA Responsible Party will be responsible for all medical device reporting, correction and removal reporting and execution of Recalls associated with any Collaboration Product, and the PMA Responsible Party will be the primary point of contact for any communications to the FDA and other Governmental Authorities, the media and customers concerning the Recall.
In the event that the Parties reasonably anticipate that First-Line FDA Approval for the first Collaboration Product will not occur within [***] days following the Antitrust Clearance Date, the Parties will confer with one another in good faith regarding re-filing of Required Filings.
Each PMA Responsible Party will provide the other Party with a copy of all final Regulatory Submissions for which it is responsible, and related correspondence (e.g., requests for additional information from a relevant Regulatory Authority and responses thereto), communications or meeting minutes that involve a material discussion of a Collaboration Product promptly after submission to or receipt from the relevant Regulatory Authority.