Common use of Manufacturing Source Clause in Contracts

Manufacturing Source. To the extent that upon the completion of Phase II of the Research Program Paravax owns, or leases pursuant to a long term lease, a manufacturing facility which has been approved by the United States Department of Agriculture or, if applicable, the United States Food and Drug Administration which allows Paravax to produce Canine Heartworm Vaccine for which regulatory approval or clearance for sale can be obtained in a specific country in the Territory, the parties shall proceed as though Paravax shall manufacture the Canine Heartworm Vaccine for distribution in that country by Bayer pursuant to the Distribution Agreement. To the extent that upon the completion of Phase II of the Research Program Paravax does not have such an approved manufacturing facility which allows it to produce Canine Heartworm Vaccine for which regulatory approval or clearance for sale can be obtained in a specific country, the parties shall proceed as though Bayer shall manufacture the Canine Heartworm Vaccine for distribution in that country by Bayer pursuant to the Distribution Agreement. Paravax may elect to forego or cease manufacture of Canine Heartworm Vaccine at any time, provided that Paravax gives Bayer adequate notice to allow Bayer, or a third party, to prepare for the manufacturing requirements of producing the Canine Heartworm Vaccine for, as applicable, Phases III ans IV of the Research Program and/or manufacture for commercial sale. After the commencement of Phase III of the Research Program, Paravax shall have no right to regain from Bayer the right to manufacture the Canine Heartworm Vaccine; however, Bayer agrees that is shall favorably consider any such request made by Paravax. In the event that Paravax elects to forego or cease manufacture of the Canine Heartworm Vaccine, Bayer shall be entitled to manufacture all of Bayer's requirements for Canine Heartworm Vaccine pursuant to the license described in Section 5.3 above.

Manufacturing Source. To the extent that upon the completion of Phase II of the Research Program Paravax owns, or leases pursuant to a long term lease, a manufacturing facility which has been approved by the United States Department of Agriculture or, if applicable, the United States Food and Drug Administration which allows Paravax to produce Canine Heartworm Toxoplasmosis Vaccine for which regulatory approval or clearance for sale can be obtained in a specific country in the Territory, the parties shall proceed as though Paravax shall manufacture the Canine Heartworm Toxoplasmosis Vaccine for distribution in that country by Bayer pursuant to the Distribution Agreement. To the extent that upon the completion of Phase II of the Research Program Paravax does not have such an approved manufacturing facility which allows it to produce Canine Heartworm Toxoplasmosis Vaccine for which regulatory approval or clearance for sale can be obtained in a specific country, the parties shall proceed as though Bayer shall manufacture the Canine Heartworm Toxoplasmosis Vaccine for distribution in that country by Bayer pursuant to the Distribution Agreement. Paravax may elect to forego or cease manufacture of Canine Heartworm Toxoplasmosis Vaccine at any time, provided that Paravax gives Bayer adequate notice to allow Bayer, or a third party, to prepare for the manufacturing requirements of producing the Canine Heartworm Toxoplasmosis Vaccine for, as applicable, Phases III ans and IV of the Research Program and/or manufacture for commercial sale. After the commencement of Phase III of the Research Program, Paravax shall have no right to regain from Bayer the right to manufacture the Canine Heartworm Toxoplasmosis Vaccine; however, Bayer agrees that is it shall favorably consider any such request made by Paravax. In the event that Paravax elects to forego or cease manufacture of the Canine Heartworm Toxoplasmosis Vaccine, Bayer shall be entitled to manufacture all of Bayer's requirements for Canine Heartworm Toxoplasmosis Vaccine pursuant to the license described in Section 5.3 above.