Clinical Supply. Lytix shall Manufacture and supply, to the extent requested by Verrica, or have Manufactured and have supplied, # API to Verrica for use in clinical trials and other Development and registration activities and # Product being Developed or Commercialized by or on behalf of Lytix for use in Verrica’s initial clinical studies, with respect to Product in the Licensed Field in the Territory, in accordance with a written clinical supply agreement to be negotiated in good faith and entered into by the Parties as soon as practicable following the Effective Date and in accordance with the principles and terms set forth in [Exhibit 0] (the “Clinical API Supply Agreement”). The Clinical API Supply Agreement will contain other normal and customary terms and conditions for such supply arrangement. Verrica shall pay Lytix for API supplied by or on behalf of Lytix to Verrica under the Clinical API Supply Agreement at a price equal to Lytix’s Cost of Goods plus a premium.
Commercial Supply. Lytix shall Manufacture and supply, to the extent requested by Verrica, or have Manufactured and have supplied, API to Verrica for commercial distribution in the Territory, in accordance with a written commercial supply agreement to be negotiated in good faith and entered into by the Parties within months after the execution of the Clinical API Supply Agreement and in accordance with the principles and terms set forth in [Exhibit 0] (the “Commercial API Supply Agreement”). The Commercial API Supply Agreement will contain other normal and customary terms and conditions for such supply arrangement. Verrica shall pay Lytix for API supplied by or on behalf of Lytix to Verrica under the Commercial API Supply Agreement at a price equal to Lytix’s Cost of Goods plus a premium.
Lytix Supply Obligation. Lytix shall, subject to the limitations set forth in 7.2(b), Manufacture and supply, or cause to be supplied, to Verrica, and Verrica shall exclusively purchase from Lytix, any or all of Verrica’s, its Affiliates’ and its and their Sublicensees’ requirements of API for # clinical trials and other non-clinical Development and registration activities in the Licensed Field in the Territory; and # commercial distribution in the Licensed Field in the Territory, in each case as described in additional detail in [Section 0]. Lytix shall supply Verrica with API in: # the form that have been developed as of the Effective Date; or # any form that, at the time of supply, is being Developed or Commercialized by or on behalf of Lytix in the Retained Field, or # any form requested by Verrica and reasonably agreed by Lytix, in each case, as is set forth in the Clinical API Supply Agreement or Commercial API Supply Agreement, as applicable. Verrica is responsible, at Verrica’s sole cost and expense, for any cartoning, packaging, for development of any requested formulations of the Product, and labeling of Product in accordance with the Applicable Laws in the Territory. Verrica is responsible, at Verrica’s sole cost and expense, for the distribution of Products in the Licensed Field in the Territory. On a quarterly basis, Lytix shall provide Verrica with copies of relevant CMC information generated by or on behalf of Lytix with respect to API, including data and information related to the development of the Manufacturing process necessary for Verrica’s regulatory processes. Verrica shall have the right to review, comment on, and approve any proposed Manufacturing process development activities for API for supply to Verrica.
General. Subject to the terms and conditions of this Agreement and the applicable Supply Agreement, Verrica has the sole right to conduct, and is solely responsible for all aspects of, the Manufacture of Drug Product (other than the API) in the Licensed Field in the Territory. Subject to the terms and conditions of this Agreement and the applicable Supply Agreement, Verrica has the right to request Lytix to Manufacture and supply Verrica with API for use in the Licensed Field in the Territory. On and after First Commercial Sale of the Product in the Licensed Field, Lytix shall maintain safety stock of API in an amount sufficient to meet months of Verrica’s requirements for API as forecasted by Verrica in accordance with the Commercial API Supply Agreement. Verrica shall be responsible for , and Lytix shall be responsible for , of the Third Party out-of-pocket cost of such safety stock of API. Verrica shall reimburse Lytix for its share of such costs upon receipt of reasonably adequate documentation indicating such Third Party costs and evidence of payment by Lytix to such Third Party. Verrica’s reimbursement of such costs shall be credited against amounts subsequently payable under the applicable Supply Agreement for the supply of such API. If such safety stock of API at any time falls below the amount sufficient to meet Verrica’s API requirements, then Lytix shall # within months thereafter, establish a second source of supply for API for use in the Licensed Field with a Third Party contract manufacturer selected by Lytix and # within months thereafter, begin to obtain supply of API for use in the Licensed Field from such Third Party contract manufacturer. Lytix shall provide any technology transfer necessary or reasonable in order for such supplier to be operational to provide API acceptable for commercial use in the Territory; provided, that any such technology transfer (including, for the avoidance of doubt, CMC and registration activities) to such supplier shall be exclusively at Lytix’s cost.
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