Common use of Confidential Clause in Contracts

Confidential. (c) Other than the press release set forth in Exhibit B, the Parties agree that any other news release or other public announcement relating to this Agreement or the performance hereunder that would disclose information other than that already in the public domain, shall first be reviewed and approved by the Parties (with such approval not to be unreasonably withheld or delayed); provided, however, that (A) as of the time ARES TRADING is solely responsible for the Development of the Product, ARES TRADING may make such press releases as it deems fit to report on the Development or Commercialization of such Product in its sole discretion, and (B) as of the time ARES TRADING declines to exercise the Intrexon Program Option for an Out-of-Scope Product, Intrexon may make such press releases as it deems fit to report on the Development or Commercialization of such Out-of-Scope Product in its sole discretion. Notwithstanding the foregoing, each Party shall have the right to disclose publicly (including on its website): (i) the fact that it has entered into this Agreement; (ii) the receipt of any milestone payments under this Agreement and the event giving rise to such payment; (iii) Regulatory Approval of any Product; (iv) the First Commercial Sale of any Product; (v) royalties received from ARES TRADING (without disclosing the royalty rate); and (vi) disclosures required by applicable law. For each such disclosure, unless either Party otherwise has the right to make such disclosure under this Article 10, such Party shall provide the other Party with a draft of such disclosure at least [*****] days prior to its intended release for such Party’s review and comment, and shall consider the other Party’s comments in good faith. If the Party does not receive comments from the other Party within [*****] business days, such Party shall have the right to make such disclosure without further delay.

Appears in 4 contracts

Samples: License and Collaboration Agreement, License and Collaboration Agreement, License and Collaboration Agreement (Intrexon Corp)

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Confidential. (c) Other than cause the press release set forth in Exhibit Bwaiting periods under the HSR Act to terminate or expire at the earliest possible date after the filing date. The Parties will, to the Parties agree that extent reasonably practicable, consult with one another prior to making any other news release filings, responses to inquiries, or other public announcement relating to contacts with the Federal Trade Commission (“FTC”) or Department of Justice (“DoJ”) concerning the transactions contemplated hereby. Each Party will bear its own expenses in connection with activities under this Agreement or the performance hereunder Section 7.6, except that would disclose information other than that already in the public domain, shall first Sanofi will be reviewed and approved by the Parties (with such approval not to be unreasonably withheld or delayed); provided, however, that (A) as of the time ARES TRADING is solely responsible for the Development fee due to the FTC in respect of such filing. Notwithstanding anything in this Agreement to the contrary, this Agreement will not become effective (with the exception of Section 3.2(g) and Exhibit G (in each case, solely to the extent transfers of Principia Know-How are designated therein to occur before the Effective Date) as well as Articles 11 and 12, Section 7.3, Section 7.4, this Section 7.6, Section 9.4 and Section 10.4) until such time as (a) the Parties shall have complied with all applicable requirements of the Product, ARES TRADING may make such press releases as it deems fit to report on HSR Act; (b) the Development or Commercialization of such Product in its sole discretion, and (B) as of waiting period under the time ARES TRADING declines to exercise the Intrexon Program Option for an Out-of-Scope Product, Intrexon may make such press releases as it deems fit to report on the Development or Commercialization of such Out-of-Scope Product in its sole discretion. Notwithstanding the foregoing, each Party HSR Act shall have the right expired or earlier been terminated with respect to disclose publicly (including on its website): (i) the fact that it has entered into this Agreement; (iic) any investigations opened by means of a second request or otherwise shall have been terminated, without action by a Government Authority to prevent the receipt of any milestone payments under Parties from implementing the transactions contemplated by this Agreement and with respect to the event giving rise to such payment; (iii) Regulatory Approval of any Product; (iv) the First Commercial Sale of any Product; (v) royalties received from ARES TRADING (without disclosing the royalty rate)U.S.; and (vid) disclosures required no requirements or conditions shall have been formally requested or imposed by applicable lawthe FTC or the DoJ in connection therewith which are not reasonably and mutually satisfactory to the Parties (collectively, the “HSR Condition” and the date upon which the HSR Condition is met will be referred to as the “Effective Date”). For each such disclosureclarity, unless achieving the HSR Condition will be the sole condition precedent to this entire Agreement coming into effect. In the event that the HSR Condition is not met within [*] from the date the filing required under the HSR Act is made, either Party otherwise has the right may terminate this Agreement upon written notice to make such disclosure under this Article 10, such Party shall provide the other Party with a draft of such disclosure at least [*****] days prior to its intended release for such Party’s review and comment, and shall consider the other Party’s comments in good faith. If the Party does not receive comments from the other Party within [*****] business days, such Party shall have the right to make such disclosure without further delay.

Appears in 2 contracts

Samples: License Agreement (Principia Biopharma Inc.), License Agreement (Principia Biopharma Inc.)

Confidential. 2.7 AMYLIN shall have the right (c) Other through any independent agents or representatives that are reasonably acceptable to LONZA and upon reasonable advance notice to LONZA), with respect to any Contract Year ending not more than thirteen […***…] prior to the press release date of notice requesting an audit, to audit the books and records of LONZA to determine whether or not the amounts reflected on any original invoices relevant to any such Contract Year or any corrected invoices issued by LONZA to AMYLIN in accordance with Paragraph 2.5 set forth immediately above are accurate. In the event that, as a consequence of any such audit or examination, AMYLIN reasonably disagrees with any amounts set forth on original or corrected invoices issued by LONZA, AMYLIN shall inform LONZA in Exhibit Bwriting and in reasonable detail of the amounts to be refunded and, unless and to the Parties extent LONZA disputes the amounts set forth by AMYLIN in any such notice, LONZA will refund to AMYLIN any such undisputed amounts within […***…] of the receipt of any such notice from AMYLIN. In the event LONZA does dispute all or any portion of any refund claimed by AMYLIN, LONZA will so notify AMYLIN within such […***…] period and the parties will attempt thereafter to resolve such dispute amicably and, if they cannot do so, may agree that to submit the dispute to binding arbitration or independently pursue any other news release or other public announcement relating remedies available to this Agreement or them to resolve such dispute. AMYLIN shall bear the performance hereunder that would disclose information other than that already in the public domain, shall first be reviewed and approved by the Parties (with expense of such approval not to be unreasonably withheld or delayed)audit; provided, however, that (A) that, if such audit reflects overpayments by AMYLIN, which are undisputed or confirmed as overpayments pursuant to the dispute resolution procedure referred to in the preceding sentence, in excess of the time ARES TRADING is solely responsible for the Development of the Product, ARES TRADING may make such press releases as it deems fit to report on the Development or Commercialization of such Product in its sole discretion, and (B) as of the time ARES TRADING declines to exercise the Intrexon Program Option for an Out-of-Scope Product, Intrexon may make such press releases as it deems fit to report on the Development or Commercialization of such Out-of-Scope Product in its sole discretion. Notwithstanding the foregoing, each Party shall have the right to disclose publicly (including on its website): (i) the fact that it has entered into this Agreement; (ii) the receipt of any milestone payments under this Agreement and the event giving rise to such payment; (iii) Regulatory Approval of any Product; (iv) the First Commercial Sale of any Product; (v) royalties received from ARES TRADING (without disclosing the royalty rate); and (vi) disclosures required by applicable law. For each such disclosure, unless either Party otherwise has the right to make such disclosure under this Article 10, such Party shall provide the other Party with a draft of such disclosure at least [*****] days prior to its intended release of the payments actually due by AMYLIN hereunder for the applicable period, then LONZA shall reimburse AMYLIN for the reasonable expenses of such Party’s review and comment, and shall consider the other Party’s comments in good faith. If the Party does not receive comments from the other Party within [*****] business days, such Party shall have the right to make such disclosure without further delayaudit.

Appears in 1 contract

Samples: Exenatide Supply Agreement (Amylin Pharmaceuticals Inc)

Confidential. (c) Other Except as otherwise expressly provided under this Agreement, all such Materials delivered to the other Party shall remain the sole property of the supplying Party, shall be used only in furtherance of the exercise of rights or performance of obligations under this Agreement and in accordance with this Agreement and solely under the control of the other Party, shall not be used or delivered to or for the benefit of any Third Party without the prior written consent of the supplying Party, and shall not be used in research or testing involving human subjects or in animals intended for food use, in each case unless otherwise specifically contemplated hereunder), and will be used in compliance with all applicable laws, rules and regulations. The provision of Materials to the receiving Party hereunder does not grant such Party any rights other than those specifically granted in this Agreement. Delivery of the press release set forth in Exhibit BMaterials shall be [***] Incoterms 2010. [***]. The receiving Party shall be responsible for any and all consents, the Parties agree that any other news release approvals, authorizations or other public announcement relating to this Agreement or permits necessary for the performance hereunder that would disclose information other than that already in the public domainuse, shall first be reviewed and approved by the Parties (with such approval not to be unreasonably withheld or delayed); providedhandling, howevertransfer, that (A) as and/or storage of the time ARES TRADING is solely responsible for the Development of the Product, ARES TRADING may make such press releases as it deems fit to report on the Development or Commercialization of such Product in its sole discretion, and (B) as of the time ARES TRADING declines to exercise the Intrexon Program Option for an Out-of-Scope Product, Intrexon may make such press releases as it deems fit to report on the Development or Commercialization of such Out-of-Scope Product in its sole discretionMaterials. Notwithstanding the foregoing, each The receiving Party shall have the right to disclose publicly (including on its website): shall: (i) receive the fact that it has entered into this AgreementMaterials; (ii) promptly notify the receipt of any milestone payments under this Agreement supplying Party when the Materials have been received; and the event giving rise to such payment; (iii) Regulatory Approval forward to the supplying Party any applicable chain of custody forms, in-transport temperature record(s) and receipt verification documentation and such other documentation reasonably requested by the supplying Party. The receiving Party shall be responsible for import clearance (including preparing any Product; (ivnecessary documentation with respect thereto) the First Commercial Sale and making entry of any Product; (v) royalties received from ARES TRADING (without disclosing the royalty rate); and (vi) disclosures required by applicable lawshipment. For each such disclosure, unless either Party otherwise has the right to make such disclosure under this Article 10, such The supplying Party shall provide the relevant shipping documentation, pro forma invoice and airway xxxx, together with such other Party documentation necessary for the use, handling, transfer, and/or storage of the Materials. The Materials supplied under this Section 2.9 are supplied “as is” and must be used with prudence and appropriate caution in any experimental work, since not all of their characteristics may be known. Except as expressly set forth herein, THE MATERIALS ARE WITHOUT ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR ANY PARTICULAR PURPOSE OR ANY WARRANTY THAT THE USE OF THE MATERIALS WILL NOT INFRINGE OR VIOLATE ANY PATENT OR OTHER PROPRIETARY RIGHTS OF ANY THIRD PARTY. During the Research Term, for record-keeping purposes, the Parties shall compile a draft list (that shall include the type of such disclosure at least [*****] days prior material, quantity, shipping date and any other relevant details) on a quarterly basis setting forth the Materials provided to/from each Party, which document shall be signed by an authorized representative of each Party. For clarity, this Section 2.9 shall apply during the Research Term only, after which the Parties will enter into an appropriate material transfer agreement with respect to its intended release for such Party’s review any transfer of Materials, which agreement will be subject to this Agreement and comment, and shall consider will be interpreted consistent with the other Party’s comments in good faith. If the Party does not receive comments from the other Party within [*****] business days, such Party shall have the right to make such disclosure without further delay.terms hereof

Appears in 1 contract

Samples: First Collaboration and License Agreement (Arrowhead Pharmaceuticals, Inc.)

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Confidential. (cb) Other than The Steering Committee shall meet (in person, or by teleconference or videoconference as agreed by the press release set forth Parties) at least [**] during the [**] and thereafter [**] (or more frequently as the Parties mutually agree is appropriate, or on such dates and at such times as the Parties shall agree. The Steering Committee (itself or through one or more sub-committees as contemplated in Exhibit BSection 2.2(a) above) will, among other things: (i) oversee the disclosure of Manufacturing Improvements in accordance with this Agreement; (ii) review and manage the Manufacturing relationship hereunder, including without limitation, review the Manufacturing requirements for QS-21 for Customer, (iii) discuss and review for Supplier’s reasonable consideration, the Parties agree [**], discuss and review validation plans for Manufacturing, QC testing and facilities, and coordinate efforts to ensure [**] between the two Parties; and (iv) address such other matters as may be agreed to between the Parties, including open matters that any other news release or other public announcement relating may exist at the level of the sub-committees. In addition and without limiting the foregoing, the Steering Committee shall meet [**] starting [**] to discuss [**] and [**], with respect to QS-21 Manufacturing to ensure that GSK will meet the Capacity Date deadline of [**]. In such meetings, GSK shall provide the Steering Committee with detailed summaries and updates with respect to the foregoing. All information provided to Antigenics MA pursuant to this Agreement or Section shall be considered the performance hereunder that would disclose information other than that already Confidential Information of GSK in the public domain, shall first be reviewed and approved by the Parties (accordance with such approval not to be unreasonably withheld or delayed)Article 9; provided, however, that GSK grants permission to Antigenics MA to disclose such information as may be necessary or reasonably useful: (Ai) as of to comply with any applicable laws, rules, regulations, or guidelines, including to reference and submit any such information to the time ARES TRADING is solely responsible FDA and other relevant Regulatory Authorities and (ii) for the Development of the Product, ARES TRADING may make such press releases as it deems fit Antigenics MA and its Affiliates and QS-21 licensees and customers to report on the Development or Commercialization of such Product in its sole discretion[**] with respect to [**], and (Bii) as for inclusion in the QS-21 BMF or comparable filing, subject to GSK’s confidential obligations to Third Parties. All information provided to GSK pursuant to this Section shall be considered the Confidential Information of the time ARES TRADING declines Antigenics MA in accordance with Article 9, provided however that Antigenics MA grants permission to exercise the Intrexon Program Option for an Out-of-Scope Product, Intrexon may make such press releases as it deems fit to report on the Development or Commercialization of such Out-of-Scope Product in its sole discretion. Notwithstanding the foregoing, each Party shall have the right GSK to disclose publicly (including on its website): such information as may be necessary or reasonably useful: (i) to comply with any applicable laws, rules, regulations, or guidelines, including to reference and submit any such information to the fact that it has entered into this Agreement; FDA and other relevant Regulatory Authorities, and (ii) the receipt of any milestone payments under this Agreement and the event giving rise for securing product license with respect to such payment; (iii) Regulatory Approval of any Product; (iv) the First Commercial Sale of any Product; (v) royalties received from ARES TRADING (without disclosing the royalty rate); and (vi) disclosures required by applicable lawQS-21 Vaccines, subject to Antigenics MA’s confidential obligations to Third Parties. For each such disclosurethe avoidance of doubt, unless either Party otherwise has nothing in this subsection shall extend the limitation on Antigenics MA’s right to make such disclosure under this Article 10, such Party shall provide the other Party with a draft of such disclosure at least grant sublicenses to practice Manufacturing Improvements to Manufacture QS-21 as set forth in Section 2.6 below. [*****] days prior = Portions of this exhibit have been omitted pursuant to its intended release for such Party’s review and comment, and shall consider a confidential treatment request. An unpredicted version of this exhibit has been filed separately with the other Party’s comments in good faith. If the Party does not receive comments from the other Party within [*****] business days, such Party shall have the right to make such disclosure without further delayCommission.

Appears in 1 contract

Samples: Manufacturing Technology Transfer And (Antigenics Inc /De/)

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