Manufacturing Process Improvements Sample Clauses

Manufacturing Process Improvements. (A) Each January 31 during the Term, beginning on January 31, 2012, Novasep shall provide to Inspire a detailed report, in a form reasonably satisfactory to Inspire, of all improvements made to the API manufacturing process during the immediately preceding year (or, in the case of the report provided on January 31, 2012, during the period between the Effective Date and January 1, 2012). Novasep shall include in each such report information necessary to support the calculation set forth in Schedule 3.1(b)(iii) or, for improvements described in Section 3.1(b)(iii)(C), an explanation of how such improvements reduce Novasep’s cost of manufacturing the API and a statement of the average amount by which such cost is reduced by such improvements on a per kilogram basis. The Parties shall discuss such reports in good faith. (B) With respect to the manufacturing steps identified in Schedule 3.1(b)(iii) as “St 3 Brut,” “St 3 [c.i.]” and “St 3 [c.i.],” the amount by which Novasep’s cost of manufacturing the API has been reduced by such improvements on a per-kilogram basis (the “Improvement Amount”) for any improvements that reduce the respective duration of any such manufacturing step to a duration that is not lower than the duration identified as the “Original Proposal” for such manufacturing step in Schedule 3.1(b)(iii) shall be calculated using the applicable formula set forth in Schedule 3.1(b)(iii). For clarity, in the event that the duration of any other manufacturing step identified in Schedule 3.1(b)(iii) is reduced to an amount that is not lower than the duration identified as the “Original Proposal” for such manufacturing step in Schedule 3.1(b)(iii), such reduction in duration will not be considered for purposes of any reduction to the API Price pursuant to this Section 3.1(b)(iii). (C) In the event that any improvement reduces the duration of any of the manufacturing steps identified in Schedule 3.1(b)(iii) below the duration identified as the “Original Proposal” for such manufacturing step in Schedule 3.1(b)(iii), the Parties shall determine the Improvement Amount for such improvement in good faith based on the report and discussions contemplated by Section 3.1(b)(iii)(A) above and an evaluation of the impact of such improvement when considered in the aggregate in light of the then-current duration of all of the manufacturing steps, using the table of durations set forth in Schedule 3.1(b)(iii). [c.i.] [c.i.]

Manufacturing Process Improvements. The following new Section 5.8 is hereby inserted into the License Agreement immediately following Section 5.7 thereof:

Manufacturing Process Improvements. Subject to the agreement of the JSC, Pharming shall have the right to include all Manufacturing Process Improvements disclosed by Orchard under Section 2.2.7(a) within the scope of the licenses under Section 3.1, such right shall be exercisable by Pharming upon written notice to Orchard on or prior to the date that is [_____] days after the JSC meeting at which Pharming are informed of such Manufacturing Process Improvements. Upon Pharming’s exercise of such right with respect to any Manufacturing Process Improvements: (i) Orchard shall use Reasonable Efforts to transfer to Pharming, and perform such activities as reasonably necessary or useful to enable Pharming to utilise, such Manufacturing Process Improvements, subject to Pharming’s reimbursement to Orchard of its Costs reasonably and actually incurred in the performance of such activities, and (ii) such Manufacturing Process Improvements shall constitute part of the Orchard Background IP and shall be licensed to Pharming under Section 3.

Manufacturing Process Improvements