Clinical Study Results. The Parties will (i) amongst each other, and (ii) with Forest, to the extent required by Applicable Law or best industry practices, coordinate the disclosure of the initiation and results of clinical studies performed pursuant to the Development and Regulatory Plan by Astellas, or its Affiliates with respect to the Licensed Compound or Product; provided that all proposed disclosures and publications will be submitted for review by the JSC and, by Ironwood, to the Joint Development Committee constituted under the Forest Agreement, and due regard will be given to the comments of each Party, the maintenance of confidentiality of Confidential Information of each Party and allowing time for intellectual property registrations. Nothing set forth in this Agreement will be deemed to limit or restrict (a) either Party from disclosing the results of clinical trials (whether performed by the Parties or by Third Parties) to the extent required by Applicable Law or best industry practices, and (b) Astellas from disclosing the results of clinical trials as reasonably determined by Astellas to be necessary in connection with Regulatory Submissions and other regulatory activities regarding the Product in the Territory.
Clinical Study Results. Subject to the right of the Joint Development Committee as constituted under the Forest Agreement to review proposed disclosures, the Parties, together with Forest, will coordinate the disclosure of the initiation and results of clinical studies performed pursuant to the Development Plan or clinical studies performed by either Party’s approved licensees or Sublicensees with respect to the Licensed Compound or Product, whether within or outside of the Territory, to the extent required by law or best industry practices; provided that all proposed disclosures and publications will be submitted for expeditious review by the JDC and the Joint Development Committee constituted under the Forest Agreement and due regard will be given to the comments of each Party, the maintenance of confidentiality of Confidential Information of each Party and allowing time for intellectual [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. property registrations. Nothing set forth in this Agreement will be deemed to limit or restrict either Party from disclosing the results of clinical trials (whether performed by the Parties or by Third Parties) to the extent required by law.
Clinical Study Results. Subject to the right of the Joint Development Committee as constituted under the Forest Agreement to review [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. proposed disclosures, the Parties, together with Forest, will coordinate the disclosure of the initiation and results of clinical studies performed pursuant to the Development Plan or clinical studies performed by either Party’s approved licensees or Sublicensees with respect to the Licensed Compound or Product, whether within or outside of the Territory, to the extent required by law or best industry practices; provided that all proposed disclosures and publications will be submitted for expeditious review by the JDC and the Joint Development Committee constituted under the Forest Agreement and due regard will be given to the comments of each Party, the maintenance of confidentiality of Confidential Information of each Party and allowing time for intellectual property registrations. Nothing set forth in this Agreement will be deemed to limit or restrict either Party from disclosing the results of clinical trials (whether performed by the Parties or by Third Parties) to the extent required by law.
Clinical Study Results. Subject to the [**], the Parties, [**], will coordinate the disclosure of the initiation and results of clinical studies performed under this Agreement or clinical studies performed by either Party’s approved licensees or Sublicensees with respect to any Licensed Compound or Product, whether within or outside of the Territory, to the extent required by applicable law or AstraZeneca’s internal policies applicable to other of AstraZeneca’s products; provided that all proposed disclosures and publications will be submitted for expeditious review by the JSC and [**] and due regard will be given to the comments of each Party, the maintenance of confidentiality of Confidential Information of each Party and allowing time for intellectual property registrations as described in Section 5.6.1. Ironwood and the JSC will each have at least 30 days, or such shorter period as may reasonably be required by applicable regulatory deadlines that are promptly communicated to Ironwood and the JSC to complete any such review. Nothing set forth in this Agreement will be deemed to limit or restrict either Party from disclosing the results of clinical trials (whether performed by the Parties or by Third Parties) to the extent required by applicable law; provided, however, that AstraZeneca will not disclose any results of clinical trials prior to the time such disclosure is required by applicable law.
Clinical Study Results. Along with the applicable then-current version of the Co-Development Cost Estimate and the Co-Development Plan to be provided to PTI pursuant to Section 3.2(b)(iii) (Co-Development Plan and Co-Development Cost Estimate), for each Co-Developed Product, Astellas will also provide to PTI the top line result of (i) the first Phase I Study for such Co-Developed Product contemplated by the Co-Development Plan no later than thirty (30) days following the Database Lock Date of such study and (ii) the first Phase II Study for such Co-Developed Product contemplated by the Co-Development Plan no later than thirty (30) days following the Database Lock Date of such study unless PTI has exercised the applicable Co-Development Termination Option.
Clinical Study Results. Subject to the [**], the Parties, [**], will coordinate the disclosure of the initiation and results of clinical studies performed pursuant to the Development Plan or clinical studies performed by either Party’s approved licensees or Sublicensees with respect to any Licensed Compound or Product, whether within or outside of the Territory, to the extent required by applicable law or AstraZeneca’s internal policies applicable to other of AstraZeneca’s products; provided that all proposed disclosures and publications will be submitted for expeditious review by the JDC and [**] and due regard will be given to the comments of each Party, the maintenance of confidentiality of Confidential Information of each Party and allowing time for intellectual property registrations as described in Section 3.8.1. Nothing set forth in this Agreement will be deemed to limit or restrict either Party from disclosing the results of clinical trials (whether performed by the Parties or by Third Parties) to the extent required by applicable law; provided, however, that AstraZeneca will not disclose any results of clinical trials prior to the time such disclosure is required by applicable law.
