Common use of Right of Negotiation Clause in Contracts

Right of Negotiation. (i) If Voyager or any Affiliate, successor, assign thereof decides not to Exploit the Product for any reason, including any such decision by Voyager following a decision by a licensee of Voyager to abandon its rights under a license from Voyager, (which Voyager shall promptly notify DURECT in writing as soon as practicable but no later than thirty (30) days after such decision) or (ii) if DURECT shall have terminated the Agreement pursuant to Section 11.2(c)(ii), DURECT shall have a right of first negotiation to obtain from Voyager an exclusive license, with the right to sublicense, under the Voyager Patents and Project Information and Inventions, and the right to use all regulatory filings, Clinical Trial data and CMC data and all other intellectual property owned by Voyager, in each case to the extent solely related to the Product, and the right to cross-reference any and all regulatory filings with respect to the Product, solely for purposes of Exploiting the Product. No later than twenty (20) days after DURECT's receipt of notice from Voyager under (i) above or the effective date of termination under (ii) above, DURECT shall notify Voyager whether it wishes to exercise its right of first negotiation. If DURECT notifies Voyager that its wishes to exercise its right of first negotiation, then Voyager shall allow DURECT to conduct reasonable diligence including providing to DURECT all information as reasonably requested by DURECT, and the Parties shall negotiate in good faith a definitive agreement covering such license to DURECT for a period not to exceed 180 days from the date of DURECT's notice of exercise. In the event that the Parties have not executed a definitive agreement within such 180-day period, then Voyager shall have no further obligations to DURECT. Prior to the exhaustion of DURECT's right under this Section 8.7, Voyager may not offer nor negotiate with any third Person any license or assignment of subject matter covered by this right of negotiation.

Appears in 3 contracts

Samples: Commercialization Agreement (Auto Search Cars, Inc.), Commercialization Agreement (Auto Search Cars, Inc.), Commercialization Agreement (Auto Search Cars, Inc.)

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Right of Negotiation. (iIn the event that Licensee determines to sublicense its rights to Commercialize a Licensed Product under an Exclusive License in its entirety or with respect to one or more country(ies) If Voyager or any Affiliateto a Third Party, successorLicensee shall so notify MTI of such determination, assign thereof decides not which notice shall include the rights contemplated to Exploit the Product for any reasonbe sublicensed, including any the proposed territory and other material rights and obligations for such decision by Voyager following a decision by a licensee of Voyager to abandon its rights under a license from Voyager, (which Voyager shall promptly notify DURECT in writing as soon as practicable but no later than thirty (30) days after such decision) or (ii) if DURECT proposed sublicense. MTI shall have terminated the Agreement pursuant [***] days from receipt of such notice to Section 11.2(c)(ii), DURECT shall have notify Licensee that it elects to exercise a right of first negotiation to obtain from Voyager an exclusive licenseand undertake all such proposed rights and obligations, as described in this Section 3.10. If MTI provides notice that it does not wish to exercise such right of negotiation or fails to provide notice during such [***] day period, Licensee shall be free to sublicense such rights without further obligation under this Section 3.10. If MTI duly exercises [***] Portions of this exhibit have been redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the right to sublicense, under the Voyager Patents and Project Information and Inventions, and the right to use all regulatory filings, Clinical Trial data and CMC data and all other intellectual property owned by Voyager, in each case to the extent solely related to the Product, and the right to cross-reference any and all regulatory filings with respect to the Product, solely for purposes of Exploiting the ProductCommission. No later than twenty (20) days after DURECT's receipt of notice from Voyager under (i) above or the effective date of termination under (ii) above, DURECT shall notify Voyager whether it wishes to exercise its right of first negotiation. If DURECT notifies Voyager that its wishes to exercise its right of first negotiation, then Voyager shall allow DURECT to conduct reasonable diligence including providing to DURECT all information as reasonably requested by DURECT, MTI and the Parties Licensee shall negotiate in good faith a definitive agreement covering the terms of such license to DURECT sublicense for a period of not less than [***] months. If such good faith negotiation does not result in a binding agreement, Licensee may sublicense such rights to exceed 180 days from a Third Party without further obligation under this Section 3.10 at any time within the [***] month period following the date of DURECT's notice expiration of exercisethe [***] month negotiation period. In the event that the Parties have If Licensee does not executed complete a definitive sublicense agreement to a Sublicensee within such 180-day period[***] month period or Licensee determines to grant a sublicense on terms more favorable to the applicable proposed Sublicensee, when taken as a whole, than those last offered by Licensee, then Voyager Licensee shall have no further obligations be required to DURECT. Prior re-offer such rights to MTI before offering such rights to a Third Party and such offer shall be then subject to the exhaustion timelines and process above. Notwithstanding anything to contrary, the obligations of DURECT's right under this Section 8.73.10 shall not apply with respect to any proposed agreement with a Third Party (a) covering both rights to be sublicensed hereunder as well as rights or obligations relating to other products of Licensee or its Affiliates or such Third Party or (b) that is of the type or scope with respect to which Licensee enters into in the ordinary course with similarly situated products, Voyager may not offer nor negotiate with any third Person any license services or assignment of subject matter covered by this right of negotiationterritories.

Appears in 2 contracts

Samples: License Agreement (Mersana Therapeutics, Inc.), License Agreement (Mersana Therapeutics, Inc.)

Right of Negotiation. (i) If Voyager or any AffiliateDuring the Term, successor, assign thereof decides not Landos grants to Exploit the Product for any reason, including any such decision by Voyager following a decision by a licensee of Voyager to abandon its rights under a license from Voyager, (which Voyager shall promptly notify DURECT in writing as soon as practicable but no later than thirty (30) days after such decision) or (ii) if DURECT shall have terminated the Agreement pursuant to Section 11.2(c)(ii), DURECT shall have a Lian an exclusive right of first negotiation to obtain from Voyager an exclusive license, with the right to sublicense, under the Voyager Patents applicable Patent Rights and Project Information and InventionsKnow-How Controlled by Landos, to Develop, Manufacture, and Commercialize and otherwise, make, have made, use, offer for sale, sell, have sold, and import Additional Products in the right to use all regulatory filingsField in the Territory (an “Additional Product License”), Clinical Trial data and CMC data and all other intellectual property owned by Voyager, in each case subject to the extent solely related remainder of this Section 2.10 (Right of Negotiation). From time to time, Landos may present Lian with information regarding Additional Products and offer Lian an opportunity to negotiate an Additional Product License (a “Trigger Notice”). Licensee may exercise its exclusive negotiation right by submitting to Landos a written offer for the Productproposed terms of such Additional Product License, including the material financial terms and a high-level development plan for the right development and commercialization of the applicable Additional Product in the Territory in one or more of the applicable indications (an “Offer”) within [***] days after receiving the Trigger Notice (the “Offer Period”). If Lian submits an Offer to cross-reference any Landos during the Offer Period, then Landos and all regulatory filings Lian shall enter into exclusive good faith negotiations regarding the terms for such Additional Product License for a period of [***] days following Landos’ receipt of such Offer (the “Negotiation Period”). If the Parties agree on the terms for such Additional Products, then the Parties may amend this Agreement to include such Additional Product License or may enter in a separate written agreement with respect to such Additional Product License. If Lian does not submit an Offer for such Additional Product License during the Product, solely for purposes of Exploiting the Product. No later than twenty (20) days after DURECT's receipt of notice from Voyager under (i) above Offer Period or the effective date Parties are unable to agree on the terms of termination under (ii) above, DURECT shall notify Voyager whether it wishes to exercise its right of first negotiation. If DURECT notifies Voyager that its wishes to exercise its right of first negotiationsuch Additional Product License or enter into an agreement with respect thereto during the Negotiation Period, then Voyager shall allow DURECT to conduct reasonable diligence including providing to DURECT all information as reasonably requested by DURECT, and the Parties shall negotiate in good faith a definitive agreement covering such license to DURECT for a period not to exceed 180 days from the date of DURECT's notice of exercise. In the event that the Parties have not executed a definitive agreement within such 180-day period, then Voyager shall have no further obligations to DURECT. Prior to the exhaustion of DURECT's right under this Section 8.7, Voyager may not offer nor negotiate with any third Person any license or assignment of subject matter covered by this right of negotiation[***].

Appears in 2 contracts

Samples: License and Collaboration Agreement (Landos Biopharma, Inc.), License and Collaboration Agreement (LianBio)

Right of Negotiation. At any time prior to the earlier of (i) If Voyager or any Affiliate, successor, assign thereof decides not to Exploit [***] of the Product for any reason, including any such decision by Voyager following a decision by a licensee of Voyager to abandon its rights under a license from Voyager, (which Voyager shall promptly notify DURECT in writing as soon as practicable but no later than thirty (30) days after such decision) or Closing Date and (ii) if DURECT shall have terminated the Agreement pursuant to Section 11.2(c)(ii)first commercial sale of a Product in [***], DURECT shall have a right within [***] of first negotiation to obtain from Voyager an exclusive license, entering into any substantive discussions or negotiations with the right to sublicense, under the Voyager Patents and Project Information and Inventions, and the right to use all regulatory filings, Clinical Trial data and CMC data and all other intellectual property owned by Voyager, in each case to the extent solely related to the Product, and the right to cross-reference any and all regulatory filings Third Party with respect to the Productgrant by Buyer or an Affiliate to such Third Party of an exclusive license to develop and commercialize any Product in [***], solely for purposes of Exploiting the Product. No later than twenty (20) days after DURECT's receipt of notice from Voyager under (i) above or the effective date of termination under (ii) above, DURECT shall notify Voyager whether it wishes to exercise its right of first negotiation. If DURECT notifies Voyager that its wishes to exercise its right of first negotiation, then Voyager shall allow DURECT to conduct reasonable diligence including providing to DURECT all information as reasonably requested by DURECT, and the Parties Buyer shall negotiate in good faith a definitive agreement covering such with Seller Parties for [***] (the “Option Period”) with respect to the acquisition by Seller Parties (or an Affiliate of Seller Parties) of an exclusive license to DURECT for a period develop and commercialize such Product in the over-the-counter market on principal terms acceptable to Seller Parties and Buyer. If, during the Option Period, Seller Parties choose not to exceed 180 days pursue such exclusive license from Buyer or its Affiliate with respect to any Product or, during such Option Period, Seller Parties and Buyer are not able to mutually agree on the date principal terms of DURECT's notice such license, Buyer shall not be barred by this Section 2.8 (Right of exerciseNegotiation) from granting a license to develop and commercialize such Product in [***] to any Third Party. In If, during the event Option Period, Buyer and Seller Parties determine that Buyer is willing to grant, and Seller Parties are willing to accept, a license to develop and commercialize any Product in [***] on principal terms acceptable to Buyer and Seller Parties, as reflected by Buyer and Seller Parties entering a signed term sheet, the Parties have not executed shall negotiate exclusively in good faith for [***] (the “Negotiation Period”) for the purpose of entering into a definitive separate license, development and commercialization agreement within such 180-day period, then Voyager shall have no further obligations to DURECT. Prior with respect to the exhaustion of DURECT's right under license to develop and commercialize such Product in [***] on terms acceptable to the Parties, acting reasonably; provided, that if Buyer and Seller Parties are unable to agree on the form of, and enter into such definitive agreement, within the Negotiation Period, Buyer shall not be barred by this Section 8.72.8 (Right of Negotiation) from granting a license to develop and commercialize such Product in [***] to any Third Party. If Buyer is permitted to grant a license to develop or commercialize a Product in [***] to a Third Party pursuant to this Section 2.8 (Right of Negotiation) but does not grant such a license to develop or commercialize such Product in [***] to any Third Party within [***] after the end of the Option Period, Voyager may Buyer shall not offer nor negotiate enter into and continue negotiations with any third Person any Third Party with respect to such a license or assignment without again complying with this Section 2.8 (Right of subject matter covered by this right of negotiationNegotiation). CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED.

Appears in 2 contracts

Samples: Asset Purchase Agreement (Roivant Sciences Ltd.), Asset Purchase Agreement (Dermavant Sciences LTD)

Right of Negotiation. (i) If Voyager or any Affiliate, successor, assign thereof decides not Auxilium wishes to Exploit Develop and Commercialize the Product for any reasonsale in the Territory in an indication outside the Field (a “New Indication”), including any then Pfizer and Auxilium shall negotiate with respect to such decision by Voyager following a decision by a licensee of Voyager New Indication in the Territory pursuant to abandon its rights under a license from Voyager, (which Voyager this Section 2.6. Auxilium shall promptly notify DURECT Pfizer in writing as soon as practicable but no later than thirty in the event it wishes to Develop and Commercialize the Product in such New Indication in the Territory, and Pfizer shall notify Auxilium in writing within twenty-eight (3028) days after receipt of such decision) notice whether or (ii) if DURECT shall have terminated the Agreement pursuant not it desires to enter negotiations as set forth in this Section 11.2(c)(ii), DURECT shall have a 2.6. If Pfizer exercises such right of first negotiation to obtain from Voyager an exclusive licensein accordance with this Section 2.6, with the right to sublicense, under the Voyager Patents and Project Information and Inventions, and the right to use all regulatory filings, Clinical Trial data and CMC data and all other intellectual property owned by Voyager, in each case to the extent solely related to the Product, and the right to cross-reference any and all regulatory filings with respect to the Product, solely for purposes of Exploiting the Product. No later than twenty (20) days after DURECT's receipt of notice from Voyager under (i) above or the effective date of termination under (ii) above, DURECT shall notify Voyager whether it wishes to exercise its right of first negotiation. If DURECT notifies Voyager that its wishes to exercise its right of first negotiation, then Voyager shall allow DURECT to conduct reasonable diligence including providing to DURECT all information as reasonably requested by DURECT, and the Parties shall negotiate in good faith (but subject to each Party’s final management approval which can be given in their absolute discretion) the terms of a definitive agreement covering regarding the Development and Commercialization of such license Product in the Territory, including the financial terms thereof. If Auxilium and Pfizer are unable to DURECT enter into a definitive agreement with respect to such transaction within sixty (60) days after receipt of the said notice (or such longer period as may be mutually agreed upon by the Parties), then Auxilium (either itself, or with its Affiliates or Third Parties) shall be permitted to Develop and/or Commercialize such New Indication in the ** CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST. Territory in each case; provided, however, that, if Pfizer determines in good faith and provides written notice within thirty (30) days after the end of such sixty (60) day period to Auxilium that it is not reasonably possible to differentiate the Product for a period such New Indication in the Territory such that it is not susceptible to exceed 180 days from use in the date of DURECT's notice of exercise. In Field, then Auxilium (its Affiliates or any Third Parties on its behalf) shall not Develop and Commercialize such New Indication in the Territory (for clarity, in the event that Pfizer reasonably determines that such New Indication is not susceptible to sufficient differentiation as is called for hereunder, Pfizer shall explain in the aforementioned written notice the reasons why such New Indication is not sufficiently differentiated, and the Parties have not executed a definitive agreement within shall discuss in good faith such 180-day period, then Voyager shall have no further obligations to DURECTdetermination). Prior to For the exhaustion purposes of DURECT's right under this Section 8.72.6, Voyager may the following formulations for any such New Indication will be considered differentiated from the formulation of the Product hereunder such that they would not offer nor negotiate be susceptible to use in the Field: (i) aerosol formulation, (ii) patch from which the active ingredient could not be removed and diluted, (iii) liquid formulation that is sufficiently dilute that it could not be used in the Field, (iv) multi-needle delivery device where the active ingredient could not be reasonably extracted for use in the Field, (v) dry powder inhalers, (vi) non-injectible gels, (vii) eye drop or other device for ocular administration, (viii) oral delivery methods, and (ix) implants that as a result of their dimensions and size cannot be used in the Field. A lyophilized or liquid formulation that could be used in, or diluted to, a concentration that would, in either case, have utility in the Field is agreed to be unacceptable such that it would be reasonable for Pfizer to refuse to consent to such a formulation for use in a New Indication. The Parties further agree and acknowledge that (A) Auxilium shall only be permitted to Develop and/or Commercialize a New Indication in the Territory under a different trademark and trade dress from that used by the Parties in the Territory and (B) nothing contained in this Section 2.6 shall prohibit Auxilium from (and this Section 2.6 shall not apply with respect to) (x) Developing or Commercializing the Product in a New Indication for sale outside the Territory, or (y) Developing or Commercializing the Product for non-human uses anywhere in the world for any third Person any license or assignment of subject matter covered by this right of negotiationindication.

Appears in 2 contracts

Samples: Development and License Agreement (Auxilium Pharmaceuticals Inc), Development and License Agreement (Auxilium Pharmaceuticals Inc)

Right of Negotiation. At any time prior to the earlier of (i) If Voyager or any Affiliate, successor, assign thereof decides not to Exploit [***] of the Product for any reason, including any such decision by Voyager following a decision by a licensee of Voyager to abandon its rights under a license from Voyager, (which Voyager shall promptly notify DURECT in writing as soon as practicable but no later than thirty (30) days after such decision) or Closing Date and (ii) if DURECT shall have terminated the Agreement pursuant to Section 11.2(c)(ii)first commercial sale of a Product in [***], DURECT shall have a right within [***] of first negotiation to obtain from Voyager an exclusive license, entering into any substantive discussions or negotiations with the right to sublicense, under the Voyager Patents and Project Information and Inventions, and the right to use all regulatory filings, Clinical Trial data and CMC data and all other intellectual property owned by Voyager, in each case to the extent solely related to the Product, and the right to cross-reference any and all regulatory filings Third Party with respect to the Productgrant by Buyer or an Affiliate to such Third Party of an exclusive license to develop and commercialize any Product in [***], solely for purposes of Exploiting the Product. No later than twenty (20) days after DURECT's receipt of notice from Voyager under (i) above or the effective date of termination under (ii) above, DURECT shall notify Voyager whether it wishes to exercise its right of first negotiation. If DURECT notifies Voyager that its wishes to exercise its right of first negotiation, then Voyager shall allow DURECT to conduct reasonable diligence including providing to DURECT all information as reasonably requested by DURECT, and the Parties Buyer shall negotiate in good faith a definitive agreement covering such with Seller Parties for [***] (the “Option Period”) with respect to the acquisition by Seller Parties (or an Affiliate of Seller Parties) of an exclusive license to DURECT for a period develop and commercialize such Product in the over-the-counter market on principal terms acceptable to Seller Parties and Buyer. If, during the Option Period, Seller Parties choose not to exceed 180 days pursue such exclusive license from Buyer or its Affiliate with respect to any Product or, during such Option Period, Seller Parties and Buyer are not able to mutually agree on the date principal terms of DURECT's notice such license, Buyer shall not be barred by this Section 2.8 (Right of exerciseNegotiation) from granting a license to develop and commercialize such Product in [***] to any Third Party. In If, during the event Option Period, Buyer and Seller Parties determine that Buyer is willing to grant, and Seller Parties are willing to accept, a license to develop and commercialize any Product in [***] on principal terms acceptable to Buyer and Seller Parties, as reflected by Buyer and Seller Parties entering a signed term sheet, the Parties have not executed shall negotiate exclusively in good faith for [***] (the “Negotiation Period”) for the purpose of entering into a definitive separate license, development and commercialization agreement within such 180-day period, then Voyager shall have no further obligations to DURECT. Prior with respect to the exhaustion of DURECT's right under license to develop and commercialize such Product in [***] on terms acceptable to the Parties, acting reasonably; provided, that if Buyer and Seller Parties are unable to agree on the form of, and enter into such definitive agreement, within the Negotiation Period, Buyer shall not be barred by this Section 8.72.8 (Right of Negotiation) from granting a license to develop and commercialize such Product in [***] to any Third Party. If Buyer is permitted to grant a license to develop or commercialize a Product in [***] to a Third Party pursuant to this Section 2.8 (Right of Negotiation) but does not grant such a license to develop or commercialize such Product in [***] to any Third Party within [***] after the end of the Option Period, Voyager may Buyer shall not offer nor negotiate enter into and continue negotiations with any third Person any Third Party with respect to such a license or assignment without again complying with this Section 2.8 (Right of subject matter covered by this right of negotiation.Negotiation). Tarpon – Asset Purchase Agreement Strictly Confidential CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED. 13

Appears in 1 contract

Samples: Asset Purchase Agreement

Right of Negotiation. (i) If Voyager or any Affiliate, successor, assign thereof decides not to Exploit the Product for any reason, including any such decision by Voyager following a decision by a licensee of Voyager to abandon its rights under a license from Voyager, (which Voyager shall promptly notify DURECT in writing as soon as practicable but no later than thirty (30) days [* * *] after such decision) or (ii) if DURECT shall have terminated the Agreement pursuant to Section 11.2(c)(ii), DURECT shall have a right of first negotiation to obtain from Voyager an exclusive license, with the right to sublicense, under the Voyager Patents and Project Information and Inventions, and the right to use all regulatory filings, Clinical Trial data and CMC data and all other intellectual property owned by Voyager, in each case to the extent solely related to the Product, and the right to cross-reference any and all regulatory filings with respect to the Product, solely for purposes of Exploiting the Product. No later than twenty (20) [* * *] days after DURECT's ’s receipt of notice from Voyager under (i) above or the effective date of termination under (ii) above, DURECT shall notify Voyager whether it wishes to exercise its right of first negotiation. If DURECT notifies Voyager that its wishes to exercise its right of first negotiation, then Voyager shall allow DURECT to conduct reasonable diligence including providing to DURECT all information as reasonably requested by DURECT, and the Parties shall negotiate in good faith a definitive agreement covering such license to DURECT for a period not to exceed 180 [* * *] days from the date of DURECT's ’s notice of exercise. In the event that the Parties have not executed a definitive agreement within such 180-day [* * *]-day period, then Voyager shall have no further obligations to DURECT. Prior to the exhaustion of DURECT's ’s right under this Section 8.7, Voyager may not offer nor negotiate with any third Person any license or assignment of subject matter covered by this right of negotiation.

Appears in 1 contract

Samples: Development and Commercialization Agreement (Durect Corp)

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Right of Negotiation. During the term of this Agreement, prior to FibroGen licensing rights to any [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Products in the Field in countries outside the Territory (iexcept for North America (i.e., the US, Canada and Mexico) If Voyager and Japan) (and, for the avoidance of doubt, with respect to a given country only prior to the execution of a license for such rights in such country), FibroGen shall notify Astellas in writing of its intent to license and Astellas shall have [ * ] to negotiate a license for such rights (during which time FibroGen and Astellas shall make appropriate personnel available for discussions about such a license); provided, however, that if FibroGen fails to execute a license with respect to such countries for the applicable Product or any Affiliate, successor, assign thereof decides not to Exploit Products within [ * ] after the Product for any reason, including end of any such decision by Voyager following a decision by a licensee of Voyager to abandon its rights under a license from Voyagersixty day period, (which Voyager the foregoing negotiation right shall promptly notify DURECT in writing as soon as practicable but no later than thirty (30) days after such decision) or (ii) if DURECT shall have terminated the Agreement pursuant to Section 11.2(c)(ii), DURECT shall have a right of first negotiation to obtain from Voyager an exclusive license, with the right to sublicense, under the Voyager Patents and Project Information and Inventions, and the right to use all regulatory filings, Clinical Trial data and CMC data and all other intellectual property owned by Voyager, in each case to the extent solely related to the Product, and the right to cross-reference any and all regulatory filings again apply with respect to the Productapplicable countries and FibroGen must provide notice for a new [ * ] negotiation period as provided above before licensing such territories for the applicable Product or Products. For the avoidance of doubt, solely for purposes of Exploiting the Product. No later than twenty (20) days after DURECT's receipt of notice from Voyager under (i) above or the effective date of termination under (ii) above, DURECT shall notify Voyager whether it wishes to exercise its right of negotiation provided for in this paragraph shall apply to any acquirer or permitted assignee of FibroGen, but shall not apply to any FibroGen sublicensee under this Agreement with respect to a given country so sublicensed, provided the foregoing negotiation rights were afforded to Astellas prior to the grant of such sublicense for such country. Right to Sublicense: Astellas’ right to sublicense to third parties, as provided in the first negotiationparagraph of the License Section of this Agreement, is [ * ], provided that [ * ]. If DURECT notifies Voyager that its wishes to exercise its right of first negotiation, then Voyager It shall allow DURECT to conduct reasonable diligence including providing to DURECT all information as reasonably requested by DURECT, and the Parties shall negotiate in good faith a definitive agreement covering such license to DURECT not be [ * ] for a period not sublicense to exceed 180 days from the date of DURECT's notice of exerciseany person that [ * ]. In the event that Astellas enters into such a sublicense with a third party (which, for the Parties have avoidance of doubt, excludes Affiliates, provided that, for the avoidance of doubt, the obligations of Astellas with respect to any activities performed under this Agreement by any Affiliates shall apply to such Affiliates), such sublicense shall (i) obligate any such third party to notify Astellas immediately if (a) such sublicensee initiates a Phase II clinical trial or otherwise engages in Commercialization activities from and after such point of initiation of a Phase II clinical trial) with human therapeutics for the treatment of an Anemia Indication, or (b) the sublicensee is acquired by, merged with, or otherwise comes under control of or common control with any entity that is Commercializing (from and after such point of initiation of a Phase II clinical trial) with a human therapeutic for the treatment of an Anemia Indication, and (ii) provide Astellas the right to terminate the sublicense if such an event described in (i) above occurs. Upon receipt of any such notice from an Astellas sublicensee, or absent such notice, upon becoming aware of any of the events described in (i)(a) or (b) above, Astellas shall exercise its right to terminate the sublicense unless the JSC approves otherwise. For avoidance of doubt, nothing in this Agreement is intended to preclude FibroGen from licensing, assigning or otherwise transferring rights to any Products in North America and in such case, FibroGen may delegate any obligations set forth herein to such sublicensee or transferee as appropriate; provided, however, for the avoidance of doubt, no such sublicense, transfer or delegation shall release or limit FibroGen’s obligations to Astellas under the terms and conditions of this Agreement. Upon execution of this Agreement, FibroGen shall provide DFCI appropriate notice of Astellas’ grant of sublicenses to (i) its Affiliates hereunder and (ii) future permitted sublicensee upon consent by FibroGen to grant such sublicense. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Designation of Products: In addition to FG-2216 and FG-4592, a HIF Compound shall become a Product hereunder when any such HIF Compound owned or Controlled by FibroGen is so designated by FibroGen (by notice to Astellas as described below) prior to the Final Development Termination Date. FibroGen shall provide notice to Astellas of any such designation, identifying the HIF Compound subject thereto. FibroGen shall consult with Astellas with respect to HIF Compounds in research and development by FibroGen that show promise for Anemia Indications and shall provide to Astellas information (other than structures) as reasonably necessary to evaluate such HIF Compounds in connection with the designation process (and generally in response to reasonable, periodic requests from Astellas and for providing periodic status reporting to the JSC), including without limitation the information relating to patent situations in the Territory. Without imposing any obligation on the part of FibroGen to identify or generate any additional HIF Compounds, FibroGen shall make good faith and diligent efforts to present potential Products that it reasonably believes offer substantial clinical benefit over then-current Products from such HIF Compounds owned or Controlled by FibroGen to the JSC for review, provided that FibroGen shall present results from any Phase II clinical trial conducted in the Field with a potential Product to the JSC for review. If Astellas, through the JSC, commits to a Development Program (as described in the development sections below) for Commercialization of such HIF Compounds, then FibroGen shall designate such HIF Compounds as Products. For the avoidance of doubt, a given HIF Compound shall be deemed designated as a Product (and written notice thereof provided to Astellas) once FibroGen (directly or indirectly, including by a licensee) Initiates a Phase III clinical trial with such HIF Compound in patients for an Anemia Indication prior to the Final Development Termination Date. Once designated as a Product(s), a given compound shall remain a Product until (a) the permanent cessation (excluding, for example, suspension, termination or completion pending further review, consideration, development planning or regulatory discussions) of all clinical studies by both parties with respect to such Product for all Indications prior to Marketing Approval, (b) the termination of all Marketing Approvals for such Product without either party intending or considering to restore or replace at least one such Marketing Approval or obtain a new Marketing Approval, or (c) the decision of the JSC to permanently cease all Commercialization of such Product for all Indications (provided such cessation of development is not executed due to the compound having already received Marketing Approval or otherwise being commercially successful), and upon the occurrence of any such event, said HIF Compound shall no longer be a definitive agreement within Product hereunder and all rights granted to Astellas by FibroGen hereunder to such 180-day HIF Compound shall revert to FibroGen. For the avoidance of doubt, when a given HIF Compound (including FG-2216 and FG-4592) becomes a Product, such designated Product shall include all salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of the active pharmaceutical ingredient that is the HIF Compound of such Product, except to the extent any of the foregoing has a different basic chemical structure than the active pharmaceutical ingredient that is the HIF Compound of such Product. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. During the [ * ] period beginning on the date that is [ * ], (each such period, then Voyager a “Look-in Period”) Astellas shall have no further obligations be given the opportunity to DURECTreview and to perform due diligence on the HIF Compounds currently being researched and developed by FibroGen for the purposes of determining whether it shall continue, after such Development Termination Date, development under the Agreement of additional Products other than those Products already designated under this Agreement. Prior In the event the [ * ] is accelerated (due to [ * ] or similar causes), such that Astellas does not get the benefit of such a [ * ] look period at such time, such [ * ] shall be extended to the exhaustion extent required to allow for such a [ * ] period. During any aforementioned Look-in Period, FibroGen shall provide such information, consultation and assistance (excluding disclosure of DURECT's right actual compound structures) as reasonably requested by Astellas to allow Astellas to conduct diligence on all eligible HIF Compounds of FibroGen that show some promise for Anemia Indications and to determine if Astellas desires to continue with Commercialization of additional Products other than those Products already designated under this Section 8.7Agreement under the Collaboration. Astellas shall indicate in writing, Voyager may not offer nor negotiate prior to such Development Termination Date, whether it wishes to extend this Agreement beyond the current (at that time) term and fund further pre-clinical and clinical development (as more fully described below) for Commercialization of additional potential Products other than those Products already designated under this Agreement under the Collaboration after the Development Termination Date. If Astellas so notifies FibroGen in writing prior to such Development Termination Date of its intent to extend the Agreement: (a) the term of the Agreement shall be extended for a minimum of ten (10) years from the then applicable Development Termination Date and the Development Termination Date itself shall be reset for a minimum of five (5) years after the then applicable Development Termination Date, with both such dates otherwise subject to extension (e.g., depending on the Patent Expiration Date) as provided for under the terms of this Agreement; (b) Astellas shall commit to participating in the Development Program for any third Person new Product designated by FibroGen hereunder during the term of this Agreement (including the Core Indications as set forth below), in accordance with the terms hereof (including by Astellas funding fifty percent (50%) of the Transatlantic Clinical Development Plan (as defined below) therefore); and (c) Astellas shall fund fifty percent (50%) of any license preclinical development work of any newly designated Products conducted in accordance with a JSC approved preclinical development plan following Product designation by FibroGen, provided that all Indications for which a Product has received Marketing Approval in the Territory or assignment shall receive Marketing Approval in the Territory in the [ * ] following such Development Termination Date shall be the only Core Indications for purposes of subject matter covered by this right of negotiationAgreement with respect to Products designated after such Development Termination Date.

Appears in 1 contract

Samples: License and Collaboration Agreement

Right of Negotiation. At any time prior to the earlier of (i) If Voyager or any Affiliate, successor, assign thereof decides not to Exploit [***] of the Product for any reason, including any such decision by Voyager following a decision by a licensee of Voyager to abandon its rights under a license from Voyager, (which Voyager shall promptly notify DURECT in writing as soon as practicable but no later than thirty (30) days after such decision) or Closing Date and (ii) if DURECT shall have terminated the Agreement pursuant to Section 11.2(c)(ii)first commercial sale of a Product in [***], DURECT shall have a right within [***] of first negotiation to obtain from Voyager an exclusive license, entering into any substantive discussions or negotiations with the right to sublicense, under the Voyager Patents and Project Information and Inventions, and the right to use all regulatory filings, Clinical Trial data and CMC data and all other intellectual property owned by Voyager, in each case to the extent solely related to the Product, and the right to cross-reference any and all regulatory filings Third Party with respect to the Productgrant by Buyer or an Affiliate to such Third Party of an exclusive license to develop and commercialize any Product in [***], solely for purposes of Exploiting the Product. No later than twenty (20) days after DURECT's receipt of notice from Voyager under (i) above or the effective date of termination under (ii) above, DURECT shall notify Voyager whether it wishes to exercise its right of first negotiation. If DURECT notifies Voyager that its wishes to exercise its right of first negotiation, then Voyager shall allow DURECT to conduct reasonable diligence including providing to DURECT all information as reasonably requested by DURECT, and the Parties Buyer shall negotiate in good faith a definitive agreement covering such with Seller Parties for [***] (the “Option Period”) with respect to the acquisition by Seller Parties (or an Affiliate of Seller Parties) of an exclusive license to DURECT for a period develop and commercialize such Product in the over-the-counter market on principal terms acceptable to Seller Parties and Buyer. If, during the Option Period, Seller Parties choose not to exceed 180 days pursue such exclusive license from Buyer or its Affiliate with respect to any Product or, during such Option Period, Seller Parties and Buyer are not able to mutually agree on the date principal terms of DURECT's notice such license, Buyer shall not be barred by this Section 2.8 (Right of exerciseNegotiation) from granting a license to develop and commercialize such Product in [***] to any Third Party. In If, during the event Option Period, Buyer and Seller Parties determine that Buyer is willing to grant, and Seller Parties are willing to accept, a license to develop and commercialize any Product in [***] on principal terms acceptable to Buyer and Seller Parties, as reflected by Buyer and Seller Parties entering a signed term sheet, the Parties have not executed shall negotiate exclusively in good faith for [***] (the “Negotiation Period”) for the purpose of entering into a definitive separate license, development and commercialization agreement within such 180-day period, then Voyager shall have no further obligations to DURECT. Prior with respect to the exhaustion of DURECT's right under license to develop and commercialize such Product in [***] on terms acceptable to the Parties, acting reasonably; provided, that if Buyer and Seller Parties are unable to agree on the form of, and enter into such definitive agreement, within the Negotiation Period, Buyer shall not be barred by this Section 8.72.8 (Right of Negotiation) from granting a license to develop and commercialize such Product in [***] to any Third Party. If Buyer is permitted to grant a license to develop or commercialize a Product in [***] to a Third Party pursuant to this Section 2.8 (Right of Negotiation) but does not grant such a license to develop or commercialize such Product in [***] to any Third Party within [***] after the end of the Option Period, Voyager may Buyer shall not offer nor negotiate enter into and continue negotiations with any third Person any Third Party with respect to such a license or assignment without again complying with this Section 2.8 (Right of subject matter covered by this right of negotiationNegotiation). Tarpon – Asset Purchase Agreement Strictly Confidential [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

Appears in 1 contract

Samples: Asset Purchase Agreement (Dermavant Sciences LTD)

Right of Negotiation. If Auxilium wishes to Develop the Bulk Product and Commercialize the Finished Product (i) If Voyager or any Affiliate, successor, assign thereof decides not to Exploit the Product for any reason, including any such decision by Voyager following a decision by a licensee of Voyager to abandon its rights under a license from Voyager, (which Voyager shall promptly notify DURECT in writing as soon as practicable but no later than thirty (30) days after such decision) or (ii) if DURECT shall have terminated the Agreement pursuant to Section 11.2(c)(ii), DURECT shall have a right of first negotiation to obtain from Voyager an exclusive license, with the right to sublicense, under the Voyager Patents and Project Information and Inventions, and the right to use all regulatory filings, Clinical Trial data and CMC data and all other intellectual property owned by Voyager, in each case to the extent solely related to the Product, and the right to cross-reference any and all regulatory filings with respect to the Product, solely for purposes of Exploiting this Section 2.6, references to “Finished Product” shall not include the specific concentrations of Product and diluent referenced in Unit of Product) for sale in the Territory in an indication outside the Field (a “New Indication”), then Actelion and Auxilium shall negotiate with respect to such New Indication in the Territory pursuant to this Section 2.6. No later than twenty Auxilium shall notify Actelion in writing in the event it wishes to Develop the Bulk Product and Commercialize the Finished Product in such New Indication in the Territory, and Actelion shall notify Auxilium in writing within twenty-eight (2028) days after DURECT's receipt of such notice from Voyager under (i) above whether or the effective date of termination under (ii) above, DURECT shall notify Voyager whether not it wishes desires to exercise its enter negotiations as set forth in this Section 2.6. If Actelion exercises such right of first negotiation. If DURECT notifies Voyager that its wishes to exercise its right of first negotiationnegotiation in accordance with this Section 2.6, then Voyager shall allow DURECT to conduct reasonable diligence including providing to DURECT all information as reasonably requested by DURECT, and the Parties shall negotiate in good faith (but subject to each Party’s final management approval which can be given in their absolute discretion) the terms of a definitive agreement covering regarding the Development of the Bulk Product and Commercialization of such license to DURECT New Indication for a period not to exceed 180 days from the date of DURECT's notice of exercise. In Finished Product in the event that Territory, including the financial terms thereof (such as applicable upfront and milestone payments), as well as the apportionment between the Parties have not executed of development costs with respect thereto. If Auxilium and Actelion are unable to enter into a definitive agreement with respect to such transaction within sixty (60) days after receipt of the said notice (or such 180-day periodlonger period as may be mutually agreed upon by the Parties), then Voyager Auxilium (either itself, or with its Affiliates or Third Parties) shall have no be permitted to Develop and/or Commercialize such New Indication in the Territory in each case utilizing a differentiated product presentation that is not reasonably susceptible to use in the Field. The Parties further obligations to DURECT. Prior to the exhaustion of DURECT's right under agree and acknowledge that nothing contained in this Section 8.72.6 shall prohibit Auxilium from (and this Section 2.6 shall not apply with respect to) (i) Developing the Bulk Product or Commercializing the Finished Product in a New Indication for sale outside the Territory, Voyager may not offer nor negotiate with or (ii) Developing the Bulk Product or Commercializing the Finished Product for non-human uses anywhere in the world for any third Person any license or assignment of subject matter covered by this right of negotiationindication.

Appears in 1 contract

Samples: Collaboration Agreement (Auxilium Pharmaceuticals Inc)

Right of Negotiation. (i) If Voyager or any Affiliate, successor, assign thereof decides not Cara grants to Exploit the Product for any reason, including any such decision by Voyager following VFMCRP a decision by a licensee of Voyager to abandon its rights under a license from Voyager, (which Voyager shall promptly notify DURECT in writing as soon as practicable but no later than thirty (30) days after such decision) or (ii) if DURECT shall have terminated the Agreement pursuant to Section 11.2(c)(ii), DURECT shall have a first right of first negotiation to obtain from Voyager an exclusive license to develop and commercialize Licensed Product in the Licensed Territory in therapeutic uses relating to the prevention or treatment of acute pain in hospital settings (the “Additional I.V. Indications”). To exercise such right, VFMCRP shall give Cara written notice of its desire to obtain such license, and such notice shall include its proposed main terms for such license. Upon such exercise of such right by VFMCRP, the Parties shall negotiate exclusively and in good faith the terms of an agreement under which Cara would grant VFMCRP an exclusive license to develop, manufacture and commercialize the Licensed Product in the Additional I.V. Indications in the Licensed Territory, such negotiation for up to [***]. If, after VFMCRP exercises such right, the Parties cannot agree within [***] after such exercise on a term sheet setting forth the main terms of an agreement covering the desired license, then thereafter Cara shall be free to negotiate and enter into any such license agreement(s) with the right to sublicense, under the Voyager Patents and Project Information and Inventions, and the right to use all regulatory filings, Clinical Trial data and CMC data and all other intellectual property owned by Voyager, in each case to the extent solely related to the Product, and the right to cross-reference any and all regulatory filings with respect to the Product, solely for purposes of Exploiting the Product. No later than twenty (20) days after DURECT's receipt of notice from Voyager under (i) above one or the effective date of termination under (ii) above, DURECT shall notify Voyager whether it wishes to exercise its right of first negotiationmore third parties. If DURECT notifies Voyager that its wishes to exercise its right of first negotiationthe Parties agreed on such term sheet during such [***] period, then Voyager shall allow DURECT to conduct reasonable diligence including providing to DURECT all information as reasonably requested by DURECT, and the Parties shall negotiate in good faith a definitive license agreement covering based on such [***] Confidential Treatment Requested term sheet during a further [***] period, during which Cara shall not be free to negotiate and enter into any such license to DURECT for a period not to exceed 180 days from the date of DURECT's notice of exercise. In the event agreement(s) with one or more third parties, and provided that if the Parties have not executed a definitive entered into such license agreement within by the end of such 180-day [*** period, then Voyager thereafter Cara shall be free to negotiate and enter into any such license agreement(s) with one or more third parties and shall not have no any further obligations to DURECTVFMCRP with respect to any Additional I.V. Indications. Prior If Cara or its Affiliates Commercialize, or grant a license to Third Party to Commercialize, a Licensed Product for an Additional I.V. Indication and/or an oral formulation of the Compound in the Licensed Territory, in compliance with the above obligations of this Section 2.10, then the Parties shall agree in good faith on an effective mechanism to (i) seek to prevent off-label sales in each other’s respective field (for VFMCRP, in the Field, and for Cara (and its Affiliates and Third Party licensees), outside the Field) in the Licensed Territory of such Licensed Product and (ii) provide adequate compensation to the exhaustion other Party for off-label sales in its respective field in the Licensed Territory of DURECT's right such Licensed Product. If such an agreement is not reached, the matter will be resolved as provided under this Section 8.7, Voyager may not offer nor negotiate with any third Person any license or assignment of subject matter covered by this right of negotiation11.4.

Appears in 1 contract

Samples: License Agreement (Cara Therapeutics, Inc.)

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