Manufacturing Improvement definition
Examples of Manufacturing Improvement in a sentence
Subject to Section 4 of the Quality Agreement, if Emergent seeks to implement any Platform Manufacturing Improvement, then Emergent shall present Aptevo with a written notice of such Platform Manufacturing Improvement, including the timeline for implementing such Platform Manufacturing Improvement and an assessment of the impact of such Platform Manufacturing Improvement, if any, on the Products.
Emergent may implement Platform Manufacturing Improvements in its sole and absolute discretion, and such Platform Manufacturing Improvement shall become part of the process by which Emergent Manufactures the Products for Aptevo under this Agreement.
Aptevo is solely responsible for providing licenses to all Intellectual Property (other than the Licensed IP) necessary for Emergent to perform services under this Agreement, except for such licenses as would be required for any Third Party Intellectual Property rights that would be infringed by any Facility Improvement or Platform Manufacturing Improvement.
Emergent shall bear all costs and expenses associated with Emergent’s implementation of any Platform Manufacturing Improvement.
Subject to Section 4 of the Quality Agreement, if Emergent seeks to implement any Product-Specific Manufacturing Improvement (whether developed by Emergent or suggested to Emergent by Aptevo), then Emergent shall present Aptevo with a written notice of such Product-Specific Manufacturing Improvement, including the timeline for implementing such Product-Specific Manufacturing Improvement and an assessment of the impact of such Product-Specific Manufacturing Improvement, if any, on the Products.
LICENSEE shall have the first right, but not the obligation, to prepare, file, prosecute and maintain any Joint Patent Right (other than any Joint [***] Manufacturing Improvement Patent Right, which, for clarity, shall be governed by Section 8.5(a)) throughout the world using patent counsel selected by LICENSEE and reasonably acceptable to AGTC.
Each Party acknowledges and agrees that “embodiments” of such intellectual property within the meaning of Section 365(n) include, without limitation, laboratory notebooks, product samples and inventory, research studies and data, all Marketing Applications and Regulatory Approvals and rights of reference therein, of the [***] Manufacturing Technology on the one hand or the LICENSEE [***] Manufacturing Improvement Technology on the other hand, and in either case, the Joint Technology.
Each Party shall promptly notify the other Party in the event of any administrative action involving any [***] Manufacturing Patent Right, Joint Patent Right or LICENSEE [***] Manufacturing Improvement Patent Right of which it becomes aware, including any nullity, revocation, reexamination, opposition, interference, inter partes and post-grant review or compulsory license proceeding.
In the event that Novo Nordisk develops (directly or through contractors) Novo Nordisk Intellectual Property that is an improvement of the PCYC Excipient manufacturing process (such Novo Nordisk Intellectual Property, a “PCYC Excipient Manufacturing Improvement”) during the Term, Novo Nordisk shall as soon as reasonably practicable disclose the PCYC Excipient Manufacturing Improvement to PCYC.
If either Party becomes aware of any potential infringement, anywhere in the world, of any issued Patent Right within the [***] Manufacturing Patent Rights, the Joint Patent Rights or the LICENSEE [***] Manufacturing Improvement Patent Rights, such Party will promptly notify the other Party in writing to that effect.