SUPPLY OF BULK DRUG SUBSTANCE AND DRUG PRODUCT. The Joint Commercialization Agreement between the Parties shall, at Nippon Kayaku's option, provide for Nippon Kayaku to supply bulk drug substance on a worldwide basis for a percentage of Net Sales of Products on commercially reasonable terms to be negotiated in good faith by the Parties. In anticipation of this supply arrangement, Nippon Kayaku will provide compounds and formulations of Research Leads for all pre-clinical and clinical studies (including toxicology studies) at a price and on such other commercially reasonable terms to be negotiated in good faith by the Parties, and Nippon Kayaku will ensure that its facilities meet all GMP and GLP standards, maintain DMFs and comply with all regulatory requirements necessary to obtain regulatory and marketing approvals. In the event that Nippon Kayaku does not provide such bulk drug substance and such drug product for all pre-clinical and clinical studies (including toxicology studies), then the foregoing option to supply bulk drug substance on a worldwide basis for a percentage of Net Sales of Products shall lapse and be of no further force or effect.
SUPPLY OF BULK DRUG SUBSTANCE AND DRUG PRODUCT. NOVARTIS will be responsible for manufacturing and supply of all Bulk Drug Substance, Drug Product Candidates and Drug Product as necessary for the conduct of the Development Plan and for all commercial purposes in the Territory. Pursuant to the provisions of Section 4.7 of the Research Agreement, the parties will agree on reasonable and appropriate measures by which manufacturing previously being undertaken by VERTEX shall be transitioned to NOVARTIS following the exercise of its Development Election with respect to a particular Drug Product Candidate. The objective of both parties will be to accomplish a smooth and timely transition. Any Bulk Drug Substance provided to NOVARTIS during the transition period will be supplied at VERTEX's reasonable Manufacturing Cost.
SUPPLY OF BULK DRUG SUBSTANCE AND DRUG PRODUCT. If, at the time the parties desire to enter into a manufacturing and supply arrangement for bulk drug substance and/or finished drug product for clinical development and commercialization of Products, LG Chem can reasonably demonstrate that it has the capacity and is otherwise able to meet the parties' supply requirements hereunder at a price competitive with bids submitted to the parties by reputable contract manufacturers of pharmaceutical products, then Elitra agrees that LG Chem shall have the right to supply such bulk drug substance and/or finished drug product at [...***...] with respect thereto for so long as LG Chem remains able to meet the parties' supply requirements hereunder on competitive terms. If the parties do not agree that LG Chem will be * CONFIDENTIAL TREATMENT REQUESTED 20. manufacturer, the parties shall cooperate to identify a single manufacturing source for the worldwide supply of bulk drug substance and finished drug product for clinical development and commercialization of Products.
SUPPLY OF BULK DRUG SUBSTANCE AND DRUG PRODUCT. With respect to Products developed for indications in the PNS Field, the Parties hereby agree that Nippon Kayaku shall have the exclusive right to manufacture and supply bulk drug substance and finished drug product on a worldwide basis. For purposes of determining the transfer price of bulk drug substance and finished drug product supplied by Nippon Kayaku hereunder, such transfer price shall [***]. Nippon Kayaku's unit transfer price for commercial bulk drug substance and finished drug product shall be no more than [***]. Signal further agrees to grant Nippon Kayaku exclusive manufacturing rights for Products developed for indications in the CNS Field, provided the granting of such rights to Nippon Kayaku does not limit the Parties' ability to obtain collaboration partners for indications in the CNS Field in the Rest of the World.
