Major Indication definition

Major Indication means a ***, excluding indications where both the (a) patient incidence of such indication is less than *** persons in the ***, and (b) estimated Net Sales of the Product for such indication in *** are less than *** per year.

Major Indication as used in (d) above means the following: cancers in any of the following: [ * ]; provided, however, that the PDL Product is [ * ] in the target cancer.

Major Indication means the following Oncology Indications: breast cancer, colorectal cancer, prostate cancer or nonl-small cell lung cancer.

Examples of Major Indication in a sentence

• For example, if the 3112 Product advances from Phase I directly to Phase III in its First Major Indication without Initiation of a Phase II study as defined in this Agreement, MedImmune shall pay the sum of the milestones for Initiation of Phase II and Initiation of Phase III [XXXXXXX].

• For the avoidance of doubt, it is hereby acknowledged and agreed that a separate milestone payment will be made for each of the foregoing milestone events ImmunoGen or its Affiliates or sublicensees hereunder achieves with a given Licensed Product, the first time each such event is achieved with respect to each Major Indication such Licensed Product is developed to treat.

• AZ shall make each of the following milestone payments to Rigel for the first Product comprising a Rigel Compound to achieve the corresponding milestone event for a Major Indication for which such milestone event has been met.

• All other milestones set forth in this Section 7.4.2 at each milestone event shall be payable only once for each Profile and only once for each Major Indication and Minor Indication, irrespective of Profile.

• The Parties acknowledge and agree that the royalty rates described in Section 8.5(a) for R788 Products reflect the fact that as of the Execution Date, R788 is the most advanced Compound in development in a Major Indication.

More Definitions of Major Indication

Major Indication means any of the following Indications: ***.

Major Indication means a separate and distinct disease or medical condition in humans for which a Product that is in Clinical Study is intended to treat, prevent and/or diagnose, or for which a Product has received Marketing Authorization, as applicable; provided that, within the field of oncology, Major Indication means a cancerous condition resulting from a separate and distinct tumor type that is the basis for a separate and distinct Marketing Authorization. For purposes of clarity, examples of different indications within the field of oncology include melanoma, nonsmall cell lung cancer, ovarian cancer, pancreatic cancer, breast cancer and head and neck cancer.

Major Indication means any discrete non-orphan Indication; provided, however, that the IBD Indications shall be treated as a single indication. By way of example only, asthma and chronic obstructive pulmonary disease would be deemed to be separate Major Indications, while severe asthma and mild to moderate asthma (or alternatively, acute versus chronic asthma) would not be deemed to be separate Major Indications.

Major Indication means sarcopenia (including aging or frailty), idiopathic short stature, a gastric dysmotility disorder (including but not limited to gastroparesis, ileus, or dyspepsia), or other indications not related to HIV or cachexia.

Major Indication means any indication in humans for which the parties mutually agree that at least five thousand (5,000) patients exist in the United States.

Major Indication means any indication with a market potential of at least [**] Dollars ($[**]) in peak year sales in the Territory, as determined by Kolltan, in consultation with MedImmune, by reference to standard industry sources.

Major Indication means any indication, including but not limited to [*], but excluding [*], in which the projected most likely gross worldwide sales of a Product are in excess of $[*] per year by the end of the [*] of the commercialization of such Product for such indication.