Therapeutic Development Milestones Clause Samples
The Therapeutic Development Milestones clause defines specific objectives or achievements that must be met during the development of a therapeutic product, such as a drug or biologic. These milestones typically include stages like completion of preclinical studies, initiation of clinical trials, regulatory submissions, or product approvals, and may trigger payments, reporting obligations, or other contractual actions. By clearly outlining these benchmarks, the clause ensures both parties have a shared understanding of progress expectations and provides a structured framework for monitoring and incentivizing development, thereby reducing ambiguity and aligning interests throughout the product development process.
Therapeutic Development Milestones. For each Therapeutic Product in each of its first 4 Therapeutic Areas, Merrimack shall report in writing to Adimab the achievement of each event and pay the corresponding development milestone payment (each a “Therapeutic Development Milestone”) to Adimab, each within [**] days after achievement of the corresponding Therapeutic Development Milestone event in the following table (whether achieved by or on behalf of Merrimack or its Affiliate or any other entity acting on behalf of any of them or having received a license, sublicense or other rights from any of the foregoing). If Merrimack requires an invoice for this purpose, then Merrimack may request one in advance in order to be able to make timely payment.
Therapeutic Development Milestones. Except as set forth in Section 6.8, within [*****] days after the occurrence of the following events (each a "Therapeutic Development Milestone"), ImClone will make the following payments to Dyax:
(a) $[*****] upon initiation of first Phase I Clinical Trial for a Therapeutic Product;
(b) $[*****] upon initiation of the first Phase III Clinical Trial for a Therapeutic Product;
(c) $[*****] upon first filing for Marketing Authorization in the first Major Market country; and
(d) $[*****] upon first Marketing Authorization of a Therapeutic Product in the first Major Market country
Therapeutic Development Milestones. Within thirty (30) days of the occurrence of each of the following events by Licensee, its Affiliates or Sublicensees with respect to a Therapeutic Antibody Product against a particular Selected Target in the first Indication, Licensee shall make the following payments to Dyax: [***] For subsequent Indications, Therapeutic Development Milestones in the above chart shall be reduced by fifty percent (50%).
Therapeutic Development Milestones. (i) $575,000 upon initiation of first Phase I Clinical Trial for a Therapeutic Product;
(ii) $1,000,000 upon initiation of the first Phase III Clinical Trial for a Therapeutic Product;
(iii) $1,650,000 upon first filing for Marketing Authorization in the first Major Market country; and
(iv) $2,000,000 upon first Marketing Authorization of a Therapeutic Product in the first Major Market country. Each Therapeutic Development Milestone shall be paid only once in connection with each Target. Dyax acknowledges the prior receipt of the milestone payment referred to in item (i) above with respect to Therapeutic Products directed to each of the Targets covered by the Previously Sublicensed CAT Product Licenses.