AEROSURF definition
Examples of AEROSURF in a sentence
This Agreement is in addition to, and not in substitution of, the Services Agreement, which covered work on aspects of the AEROSURF program.
Notwithstanding the foregoing, Discovery Labs shall have final decision-making authority and the final say on all matters relating to the design, Registration, manufacture, packaging, marketing, distribution and sale of the AEROSURF System, and any final decision made by Discovery Labs on such matters shall not be subject to any further review under the dispute resolution provisions of Section 6.A(ix) of this Agreement or in any court or other forum either at law or in equity.
The activities as defined in the Project Plan of this Agreement are required to further the AEROSURF program and will be performed under the terms of this Agreement.
To its knowledge, there is no material unauthorized use, infringement or misappropriation of any of its patents, copyrights, trademarks, trade secret rights or know-how necessary or useful to make, use or sell the AEROSURF System.
In addition, Discovery Labs specifically acknowledges that Battelle is a service provider and contract manufacturer and not a distributor or supplier and Discovery Labs retains all final decision making authority and all responsibility for the design, manufacture, packaging, marketing, distribution and sale of the AEROSURF System, including, without limitation, product labeling, warnings, and instructions to users.
Such activities may include, but shall not be limited to, adhering to Registration requirements in the U.S., conducting or providing for the manufacture of devices and drug product, and conducting or providing for marketing, selling, distribution and warranty of AEROSURF.
This Agreement, the Exhibits attached hereto, and together with the Services Agreement, the CDA, and any Quality Agreement between the Parties, sets forth the terms of the agreement regarding AEROSURF System between the Parties hereto and, except for the CDA incorporated therein, the Quality Agreement and as otherwise set forth herein, supersedes and terminates all prior representations, term sheets, agreements and understandings between the Parties regarding the subject matter hereof.
Other than as specifically set forth in this Agreement, including Discovery Labs’ obligation to pay Battelle invoices, [***]; provided that, if Discovery Labs terminates this Agreement pursuant to Clause (ii) of this Section 5.C after Battelle has successfully completed Stage 3, and if Discovery Labs or an Affiliate subsequently Registers AEROSURF based on the AEROSURF System developed by Battelle in the Territory [***], then Discovery Labs or an Affiliate [***] provided in Section 3.D(ii).
The Parties contemplate that, if AEROSURF is approved, they will negotiate in good faith to enter into a supply agreement providing for initial commercial supply.
Battelle acknowledges that the success of the Project Plan, and the efforts by Discovery Labs to secure Registration, and execute a commercial launch for, AEROSURF in the U.S. are subject to a variety of risks and uncertainties that could cause results to differ materially from those set forth in the Project Plan or otherwise anticipated by the Parties.