Second Indication Clause Samples
The "Second Indication" clause defines the terms under which a product, drug, or technology may be developed, marketed, or licensed for a therapeutic use beyond its original approved indication. Typically, this clause outlines the rights and obligations of the parties if they wish to pursue regulatory approval or commercialization for a new medical condition or patient population. For example, if a pharmaceutical company has a drug approved for one disease, the clause would address how the parties handle development and revenue sharing if the drug is later found effective for a different disease. The core function of this clause is to clarify ownership, responsibilities, and financial arrangements related to expanding the use of a product, thereby preventing disputes and ensuring both parties understand their roles in future developments.
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Second Indication. (i) Upon []* $ [] *
(ii) Upon []* $ [] *
(iii) Upon []* by Cubist or a Related Party of Cubist $ [] * *Confidential Treatment Requested. Omitted portions filed with the Commission.
(iv) Upon []* $ [] *
(v) Upon []* by Cubist or a Related Party of Cubist $ [] *
(vi) Upon []* by Cubist or a Related Party of Cubist $ [] *
(vii) Upon []* by Cubist or a Related Party of Cubist $ [] * For the avoidance of doubt, each of the foregoing milestone payments shall be paid only once by Cubist, and once paid for any given Product or Cubist Product, shall not apply to any other Product or Cubist Product subsequently developed by Cubist that subsequently achieves the same milestone. Consequently, the maximum amount that Cubist could be obligated to pay to Dyax under this Section 7.3 is []*.
Second Indication. Reneo shall make each of the non-refundable and non-creditable development milestone payments set forth in the table below in this Section 3.3(b) (“Table 3.3(b)”) to vTv within thirty (30) days after the first achievement (whether by or on behalf of Reneo or any of its Affiliates or, subject to Section 3.6, Sublicensees) of the corresponding milestone event set forth in Table 3.3(b) by the first Licensed Product to achieve such milestone event for the second Indication (i.e., the first additional Indication other than the First Indication for which the milestone payment for the corresponding milestone event in Table 3.3(a) was paid). The Indication in which each milestone event in Table 3.3(b) is first achieved by any Licensed Product, after achievement of the corresponding milestone event in Table 3.3(a) in the First Indication is referred to herein as the “Second Indication”; provided, however, that the Indication constituting the “Second Indication” in which a given milestone event in Table 3.3(b) is achieved may be the same as or different from the Indication constituting the “Second Indication” in which any other milestone event in Table 3.3(b) is achieved. Each milestone payment set forth in Table 3.3(b) shall be paid only once during the Term, for the first time any Licensed Product reaches such milestone event for the Second Indication in which such milestone event is achieved, regardless of the number of Licensed Products that achieve such milestone event, the number of times such milestone event is achieved by any Licensed Product, or the number of additional Indications in which such milestone event is subsequently achieved. For clarification, the total milestone payments payable under this Section 3.3(b) if all milestone events in Table 3.3(b) are achieved for a Second Indication is [***]. [***] [***] [***] [***] [***] [***] [***] [***]
Second Indication. “Second Indication” means the initial indication (other than for the [***]) for which there has been a First Dose in a Registrational Trial of Aeroquin.
Second Indication. In partial consideration of the rights granted by AstraZeneca to Licensee hereunder, payments of [***] of the foregoing amounts shall be payable to AstraZeneca from Licensee within [***] ([***]) [***] after the achievement of each of the foregoing milestone events with respect to a Licensed Product in the second indication to reach such milestone, which shall be non-refundable, non-creditable and fully earned upon the achievement of the applicable milestone event. Each milestone in this Section 4.3.1 (ii) shall be accrued on a Licensed Product-by-Licensed Product basis based on the first achievement of such milestone for the applicable Licensed Product, and shall be paid after the first commercial booking for the Licensed Product.
Second Indication. With respect to milestone events (2) through (5), inclusive, in each of the above tables in this Section 7.4.3, in addition to the milestone payments specified therein for the first Indication, a corresponding milestone payment will be due in the 58 *Confidential Treatment Requested.
Second Indication. If, with respect to a particular Collaboration Compound or Collaboration Back-Up Compound, Celgene, itself or through its Affiliates or Sublicensee, achieves Development Milestones [ * ] for a second therapeutic indication having a separate histology (i.e., multiple myeloma and breast cancer, not first-line to second-line multiple myeloma therapies), Celgene shall make an additional payment to Array of [ * ] of the corresponding milestone payments set forth in Section 6.3.1 above. For the avoidance of doubt, Celgene shall not be obligated to make any milestone payments beyond the second indication.
Second Indication. With respect to the Second Indication, if, upon achievement of the first to occur of any of milestone events (3), (4) or (5) set forth in the table in Section 7.4.3(a), (b) or (c), as applicable, the milestone payment with respect to such Development Candidate for milestone event (2) set forth in such table (and subject to Section 7.4.3(a), (b) or (c), as applicable) has not been paid for such Development Candidate, then such milestone payment shall be payable concurrently with the payment for such subsequent achievement with respect to milestone event (3), (4) or (5) set forth in such table, as applicable;
Second Indication. In partial consideration of the rights granted by Highlightll to Biohaven hereunder, payments of fifty percent (50%) of the foregoing amounts in 4.3.1(i) shall be payable to Highlightll from Biohaven within [***] after the achievement of each of the foregoing milestone events with respect to the first Licensed Product in the second indication to reach such milestone (whether by Biohaven, an Affiliate, or a Sublicensee), which shall be non-refundable, non-creditable and fully earned upon the achievement of the applicable milestone event.
Second Indication. Upon first acceptance of a filing of an MAA for the Compound and/or Product for a second indication in Japan by or under authority of Astellas, Astellas shall pay XenoPort [… * …]. Upon obtaining the first Marketing Approval of the Compound and/or Product for a second indication in Japan by or under authority of Astellas, Astellas shall pay XenoPort [… * …]. As used herein, a “second indication” shall mean any indication for which Marketing Approval is obtained, other than the indication triggering payment under Section 6.2.6 above.
Second Indication. (i) Eloxx has the right to file an IND and initiate the Proof of Concept Clinical Trial in respect of the Licensed Product in the Second Indication, but only after the end of a period of twelve (12) months of completion of the Proof of Concept Clinical Trial for a Licensed Product in the First Indication. Licensee shall notify Eloxx in writing whether or not it intends to Develop the Licensed Product for the Second Indication, such notification to be provided within such 12 month period after completion of the Proof of Concept Clinical Trial for the Licensed Product. If the Licensee notifies Eloxx that it will not Develop the Licensed Product in the Second Indication, Eloxx shall have the right but not the obligation to take over the Development up to completion of the Pivotal Clinical Trial of the Licensed Product in the Second Indication. If Eloxx intends to pursue such Development it will notify Licensee in writing, it being agreed that Licensee retains the right to at any time take over the Development of the Licensed Product in the Second Indication. Upon successful completion of a Pivotal Clinical Trial in the Second Indication, the Licensee and Eloxx shall undertake good faith discussions to determine the appropriate Commercialization plan for the Licensed Product in the Second Indication. For clarity if Licensee obtains Regulatory Approval for the Licensed Product in the Second Indication in either the US, the EU or Japan, Licensee shall use its Commercially Reasonable Efforts to Launch the Licensed Product in the Second Indication in such country. 50
(ii) In the event that Eloxx elects to undertake the Development of the Licensed Product in the Second Indication, (a) Eloxx shall manage all regulatory activity in relation to the Licensed Product in the Second Indication and all Intellectual Property that it creates in carrying out such Development and (b) Licensee:
(A) shall at Eloxx's request, allow Eloxx or its Affiliate to cross reference Licensee's IND filings and all other regulatory filings and Regulatory Approvals owned or controlled by Licensee or its Affiliates in relation to the Licensed Product, for the sole purpose of performing clinical development of the Licensed Product in the Second Indication;
(B) hereby grants to Eloxx, and Eloxx hereby accepts, a non-exclusive, royalty-free, worldwide, sublicensable license to and under Licensee Background IP and Licensee Improvements for the sole purpose of carrying out the Development of the Li...