Common use of Right of First Negotiation Clause in Contracts

Right of First Negotiation. If during the Inhaled Option Period and/or Vaccines Option Period, Liquidia desires to grant a non-exclusive license to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iii), then it shall first notify GSK and GSK Bio of such desire in writing, describing in reasonable detail the scope of the license it is interested in granting to a Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice”) and GSK and/or GSK Bio thereafter shall have the exclusive right of first negotiation to obtain an exclusive, worldwide, sublicensable license to Liquidia’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio shall have thirty (30) days from the receipt of the ROFN Notice to inform Liquidia in writing of its election to negotiate the terms of such exclusive license, and another thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice during the first thirty (30) day period and submits the initial proposal within the second thirty (30) day period, Liquidia shall negotiate exclusively in good faith with GSK or GSK Bio, for a period not to exceed six (6) months from GSK’s or GSK Bio’s receipt of the ROFN Notice (the “Negotiation Period”), the terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by the end of the Negotiation Period, then Liquidia shall be free to negotiate with any Third Party for a non-exclusive license within the same applicable field that was the subject of negotiations with GSK or GSK Bio, and to grant such non-exclusive license to any Third Party; provided, that if Liquidia grants such non-exclusive license to a Third Party within nine (9) months after the expiration of Negotiation Period, then the terms of such Third Party license shall be no less favorable to Liquidia than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokines.

Appears in 5 contracts

Samples: Inhaled Collaboration and Option Agreement (Liquidia Technologies Inc), Inhaled Collaboration and Option Agreement (Liquidia Technologies Inc), Inhaled Collaboration and Option Agreement (Liquidia Technologies Inc)

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Right of First Negotiation. If during the Inhaled Option Period and/or Vaccines Option PeriodIf, Liquidia desires ***, XXXXX seeks to grant a non-exclusive license to its interest in or a similar transfer of rights, whether or not under the Joint Inhaled Collaboration Licensed Patents or Licensed Know-How or Joint Vaccines Collaboration KnowHow, to a Third Party for development and/or commercialization of any Royalty-How as described in Section 11.4(b)(iiiBearing Product (collectively, an “Out-License”), then it XXXXX will notify ONYX in advance in writing and provide a non-confidential summary of the Royalty-Bearing Product that is the subject of the proposed license, as well as the intended scope (i.e., field and territory) of the Out-License (a “Transaction Notice”). If ONYX has a good faith interest in evaluating such Out-License for the purpose of itself entering into an agreement with respect to the Out-License, then ONYX will notify XXXXX within *** days of its receipt of the Transaction Notice setting forth that Onyx has a good faith interest in obtaining a license to the Royalty-Bearing Product that is the subject of the Out-License (a “Negotiation Notice”). Promptly after XXXXX’x receipt of a Negotiation Notice, XXXXX will provide ONYX with a confidential summary of the Royalty-Bearing Product (each, a “Summary”), including material clinical and preclinical data (as well as such other information that ONYX may reasonably request), which Summary shall first notify GSK and GSK Bio be deemed to be Confidential Information of XXXXX under this Agreement. For *** days following ONYX’s receipt of a Summary (the “Exclusivity Period”), ONYX will have an exclusive right to negotiate in good faith an exclusive, royalty-bearing license to such desire in writing, describing in reasonable detail Royalty-Bearing Product from XXXXX within the scope of the license it is interested in granting to a Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice”) and GSK and/or GSK Bio thereafter shall have the exclusive right of first negotiation to obtain an exclusive, worldwide, sublicensable license to Liquidia’s interest transaction described in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, and any other intellectual property rights Transaction Notice. If ONYX (which may include Liquidia Technologya) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products in does not deliver a Negotiation Notice to XXXXX within the applicable field *** day period, (i.e. b) does not deliver to XXXXX a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio shall have thirty (30) days from the receipt of the ROFN Notice to inform Liquidia in writing of its election to negotiate the terms of such exclusive license, and another thirty (30) days to submit to Liquidia an initial written proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice an Out-License to ONYX during the first thirty Exclusivity Period, or (30c) day period declines in writing the Out-License after review of the Summary, then ONYX shall be deemed to have waived its rights under this Section 2.3 (Right of First Negotiation) with respect to such Royalty-Bearing Product (but solely to the extent materially consistent with the Transaction Notice). Notwithstanding the preceding sentence to the contrary, if ONYX and submits XXXXX do not mutually agree on the initial proposal terms of an Out-License to ONYX within the second thirty Exclusivity Period, XXXXX will be free to negotiate an Out-License for such Royalty-Bearing Product with any Third Party, subject to the terms of Section 2.2.1 (30) day period, Liquidia shall negotiate exclusively in good faith with GSK or GSK BioSublicenses Generally), for a period not to exceed six *** = INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. of *** (6) months from GSK’s or GSK Bio’s receipt of the ROFN Notice (the “Negotiation Period”), the terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by at the end of the Negotiation Periodsuch *** period, then Liquidia ONYX’s right to exclusively negotiate an Out-License shall automatically be free to negotiate with any Third Party for a non-exclusive license within the same applicable field that was the subject of negotiations with GSK or GSK Bio, and to grant such non-exclusive license to any Third Partyreinstated); provided, however, that if Liquidia grants such non-exclusive license XXXXX shall not be entitled to subsequently grant development or commercialization rights to a Third Party within nine (9) months after on financial and commercial terms materially less favorable, in the expiration aggregate, to XXXXX than those last offered by ONYX or with a materially broader scope than as set forth in the Transaction Notice. For the sake of Negotiation Periodclarity, then an Out-License shall not include the terms grant of such Third Party a license shall be no less favorable to Liquidia than the terms last proposed by GSK a Service Provider or GSK Bio to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Knowdistributor selling finished Royalty-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded Bearing Product purchased from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokinesXXXXX.

Appears in 3 contracts

Samples: Exclusive License Agreement, Exclusive License Agreement (Kezar Life Sciences, Inc.), Exclusive License Agreement (Kezar Life Sciences, Inc.)

Right of First Negotiation. If during Prior to negotiating with or entertaining offers from a Third Party to license the Inhaled Option Period and/or Vaccines Option PeriodVaccine Product Rights, Liquidia desires ACI shall first notify Genentech in writing and such notification shall be accompanied by all information in ACI’s Control as reasonably necessary or useful for Genentech to grant a non-exclusive license to evaluate its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iiiVaccine Product Rights (including information and data regarding safety, efficacy, toxicity, potential side effects and any and all Marketing Approval filings), then it . Genentech shall first notify GSK and GSK Bio have [*****] calendar days from receipt of such desire in writing, describing in reasonable detail notice to notify ACI of Genentech’s intent to negotiate for the scope Vaccine Product Rights. Upon receipt by ACI of the license it is interested in granting to a Third Party from whom Liquidia has received a term sheet or letter Genentech’s notice of intent to negotiate, ACI shall negotiate solely and in good faith with Genentech for a period of [*****] calendar days (the “ROFN Notice”) and GSK and/or GSK Bio thereafter shall have the exclusive right of first negotiation to obtain an exclusive, worldwide, sublicensable license to Liquidia’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio shall have thirty (30) days from the receipt of the ROFN Notice to inform Liquidia in writing of its election to negotiate the terms of such exclusive license, and another thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice during the first thirty (30) day period and submits the initial proposal within the second thirty (30) day period, Liquidia shall negotiate exclusively in good faith with GSK or GSK Bio, for a period not to exceed six (6) months from GSK’s or GSK Bio’s receipt of the ROFN Notice (the “Negotiation Period”), the terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail the Parties are unable to reach a binding written agreement for agree on substantive terms within the exclusive license by the end of the Negotiation ROFN Period, then Liquidia Genentech shall promptly reduce to writing its last offer to ACI and provide such writing to ACI, and ACI shall be free to negotiate enter into an agreement with any Third Party for a non-exclusive license within the same applicable field that was the subject Research Collaboration and License Agreement 14 of negotiations with GSK or GSK Bio42 CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 406 UNDER THE SECURITIES ACT OF 1933, and to grant such non-exclusive license to any Third Party; provided, that if Liquidia grants such non-exclusive license to a Third Party within nine (9) months after the expiration of Negotiation Period, then the terms of such Third Party license shall be no less favorable to Liquidia than the terms last proposed by GSK or GSK Bio to LiquidiaAS AMENDED. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with **] INDICATES OMITTED MATERIAL THAT IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST FILED SEPARATELY WITH THE COMMISSION. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION. FINAL EXECUTION DOCUMENT Third Party for the Securities and Exchange Commission pursuant to Rule 24b-2 sale or licensing of the Securities Exchange Act ACI Vaccine Rights provided that the financial terms of 1934such agreement shall be no more favorable to the Third Party than those last offered by Genentech. If ACI is unable to enter into an agreement with a Third Party on terms that are not more favorable to the Third Party than those terms last offered by Genentech and ACI notifies Genentech of ACI’s desire to resume negotiations, as amended. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products that cause the Parties agree to negotiate in good faith to reach a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokinesdefinitive agreement on mutually acceptable terms.

Appears in 2 contracts

Samples: Research Collaboration and License Agreement (AC Immune SA), Research Collaboration and License Agreement (AC Immune SA)

Right of First Negotiation. (a) If during after the Inhaled Option Period and/or Vaccines Option PeriodEffective Date PTI develops, Liquidia desires has developed or otherwise comes to grant a non-exclusive license to its interest in the Joint Inhaled Collaboration Control Know-How or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iii)Patent Rights outside of the Collaboration, then it shall first notify GSK and GSK Bio PTI initiates the use or practice of such desire in writing, describing in reasonable detail the scope of the license it is interested in granting to a Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice”) and GSK and/or GSK Bio thereafter shall have the exclusive right of first negotiation to obtain an exclusive, worldwide, sublicensable license to Liquidia’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, Patent Rights as applicable, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio shall have thirty (30) days from the receipt part of the ROFN Notice to inform Liquidia in writing of its election to negotiate the terms of Collaboration, or either Party otherwise determines that such exclusive license, and another thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice during the first thirty (30) day period and submits the initial proposal within the second thirty (30) day period, Liquidia shall negotiate exclusively in good faith with GSK or GSK Bio, for a period not to exceed six (6) months from GSK’s or GSK Bio’s receipt of the ROFN Notice (the “Negotiation Period”), the terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by the end of the Negotiation Period, then Liquidia shall be free to negotiate with any Third Party for a non-exclusive license within the same applicable field that was the subject of negotiations with GSK or GSK Bio, and to grant such non-exclusive license to any Third Party; provided, that if Liquidia grants such non-exclusive license to a Third Party within nine (9) months after the expiration of Negotiation Period, then the terms of such Third Party license shall be no less favorable to Liquidia than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-HowPatent Rights are necessary or useful to Biogen Idec to Develop one or more Licensed Products that Biogen Idec is actively Developing or Commercializing (“Additional Intellectual Property”), as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date then PTI will promptly notify Biogen Idec in writing of the ROFN Noticesuch Additional Intellectual Property, and all Biogen Idec will have [***] from its receipt of such Joint Inhaled Collaboration Know-How notice to determine whether it wishes to enter into negotiations with PTI for a license under such Additional Intellectual Property to research, Develop, manufacture, use, sell and import such applicable Licensed Product(s) in the Field and for no other purpose. If Biogen Idec notifies PTI in writing that it would like to enter into negotiations for such license, the Parties will negotiate in good faith for a period of up to [***] to reach agreement on a license agreement for such Additional Intellectual Property. If the Parties are able to enter into such a license agreement, then the Parties’ respective rights and obligations with regard to such Additional Intellectual Property will be set forth in such agreement. If (i) Biogen Idec informs PTI that it does not wish to enter into negotiations with PTI for an exclusive license under such Additional Intellectual Property, (ii) Biogen Idec fails to provide such notice that it wishes to enter into negotiations with PTI for an exclusive license under such Additional Intellectual Property within the required [***] period, or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How iii) Biogen Idec provides notice that arises after it wishes to enter into negotiations with PTI for an exclusive license under such Additional Intellectual Property within the expiration of Negotiation Period) shall be thereafter excluded from and not subject required [***] period, but the Parties fail to this Section 4.3 as come to agreement on such a license agreement within the required [***] period then, in each case, PTI will have no further obligations to Biogen Idec with regard to the particular field proposed applicable Additional Intellectual Property; except that, PTI may not license such Additional Intellectual Property to GSK. Furtherresearch, each time Liquidia desires Develop, manufacture, use, sell and import the applicable Licensed Product(s) on terms that are materially less favorable to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK PTI in the right aggregate than those offered by Biogen Idec in its final offer for a period of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such an additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokines.

Appears in 2 contracts

Samples: And License Agreement, And License Agreement (Proteostasis Therapeutics, Inc.)

Right of First Negotiation. If during During the Inhaled Option Period and/or Vaccines Option PeriodTerm, Liquidia desires to grant a non-exclusive license to its interest each Company Licensee shall promptly notify the applicable Pfizer Licensor in writing in the Joint Inhaled Collaboration Know-How event that it invents or Joint Vaccines Collaboration Know-How as described otherwise generates any improvements, modifications, or upgrades to any Third Party IP that are licensed to a Pfizer Licensor pursuant to the Scripps Agreement or any Patent Rights that, from time to time, the Parties identify as, and agree in writing are, the Patent Rights to which this Section 11.4(b)(iiishall apply (“Scripps Improvements”), then it shall first notify GSK and GSK Bio . Upon receipt of such desire in writingwritten notice from such Company Licensee, describing in reasonable detail the scope of the license it is interested in granting to a Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice”) and GSK and/or GSK Bio thereafter shall have the exclusive right of first negotiation to obtain an exclusive, worldwide, sublicensable license to Liquidia’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio Pfizer Licensor shall have thirty (30) days from the receipt of the ROFN Notice to inform Liquidia notify such Company Licensee that it intends to enter into negotiations with such Company Licensee to be granted exclusive rights with respect thereto. If such Pfizer Licensor does not so notify such Company Licensee in writing of its election to negotiate the terms of within such exclusive license, and another thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice during the first thirty (30) day period that it intends to enter into negotiations with such Company Licensee, then such Company Licensee shall be permitted to license any Patent Rights or Know-How that it Controls and submits that relates to the initial proposal Scripps Improvements to any Third Party on any terms (subject to the terms and conditions of the Scripps Agreement). In the event that such Pfizer Licensor provides such Company Licensee with such a written notice that it intends to enter into negotiations with such Company Licensee, such Pfizer Licensor and such Company Licensee shall enter into good faith negotiations in order to conclude an agreement within ninety (90) days from expiration of the second thirty (30) day period described in the foregoing sentence. In the event that such Pfizer Licensor and Company Licensee do not enter into a definitive written agreement within such ninety (90) day period, Liquidia shall negotiate exclusively in good faith with GSK or GSK Bio, for a period not to exceed six (6) months from GSK’s or GSK Bio’s receipt of the ROFN Notice (the “Negotiation Period”), the terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by the end of the Negotiation Period, then Liquidia shall be free to Company Licensee may thereafter negotiate with any Third Party for a non-exclusive license within the same applicable field Parties; provided that was the subject of negotiations such Company Licensee and its Affiliates may not enter into such an agreement with GSK or GSK Bio, and to grant such non-exclusive license to any Third Party; providedParty on terms which, that if Liquidia grants such non-exclusive license taken as a whole, are substantially identical to, or materially more favorable to a Third Party within nine (9) months after the expiration of Negotiation Period, then the terms of such Third Party license shall be no less favorable to Liquidia than than, the terms last proposed offered by GSK or GSK Bio such Company Licensee to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokinesPfizer Licensor.

Appears in 2 contracts

Samples: Patent And (Zoetis Inc.), Patent And (Zoetis Inc.)

Right of First Negotiation. If during the Inhaled Option Period and/or Vaccines Option Period, Liquidia desires to grant a non-exclusive license to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iii), then it shall first notify GSK and GSK Bio of such desire in writing, describing in reasonable detail the scope of the license it is interested in granting to a Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice”) and GSK and/or GSK Bio thereafter shall have the This Agreement includes an exclusive right of first negotiation (the “ROFN”) for ImmunoGen to obtain an exclusiverights to develop or commercialize, worldwideeither alone or with Licensee, sublicensable license to Liquidiathe Product in North America. Upon Licensee’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, completion of a Phase 2 Clinical Trial for a Product and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio shall have thirty (30) days from the receipt of the ROFN Notice to inform Liquidia in writing of its election to negotiate the terms of such exclusive license, and another thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice during upon the first thirty to occur of (30i) day period and submits the initial proposal within the second thirty (30) day period, Liquidia shall negotiate exclusively Licensee notifying ImmunoGen that its Board of Directors has directed management to undertake in good faith with GSK efforts to identify potential licensees or GSK Biocollaborators to develop and commercialize the Product or (ii) the date upon which the Licensee provides ImmunoGen a copy of the final and complete set of locked clinical trial data tables, figures, listings and safety reviews including, but not limited to, all statistical analyses and related data as per the clinical trial protocol and related statistical analysis plan (the “Phase 2 Clinical Trial Results”) for such Phase 2 Clinical Trial, Licensee shall notify ImmunoGen and for a period of [***] thereafter, ImmunoGen may exercise its ROFN by notifying Licensee in writing (the “lmmunoGen Option Exercise Notice”). If ImmunoGen does not exercise the ROFN during such [***] period, then Licensee shall be free to exceed six (6) months from GSK’s offer the opportunity to obtain a license to develop or GSK Biocommercialize the Product in North America to any third party and ImmunoGen shall have no further rights to the Product. If ImmunoGen exercises the ROFN, the Parties shall negotiate in good faith on an exclusive basis for up to [***] after the date of Licensee’s receipt of the ROFN ImmunoGen Exercise Option Notice (the “ImmunoGen License Negotiation Period”), . During this time the Parties would negotiate the terms under which Liquidia will this Agreement may be terminated and an agreement pursuant to which Licensee would grant such ImmunoGen an exclusive license (the “lmmunoGen Exclusive License”) with the right to GSK sublicense, under the Licensee IP to use, Develop, Commercialize and Manufacture the Products (and Compounds to the extent included or GSK Bioincorporated, or intended to be included or incorporated, in a Product) in North America. During the ImmunoGen License Negotiation Period, Licensee shall not offer the opportunity to obtain a license to develop or commercialize the Product in North America to any other third party. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license Parties have not entered into the ImmunoGen Exclusive License by the end of the ImmunoGen License Negotiation Period, then Liquidia Licensee shall be free to negotiate with any Third Party for offer the opportunity to obtain a non-exclusive license within the same applicable field that was the subject of negotiations with GSK or GSK Bio, and to grant such non-exclusive license to develop or commercialize the Product in North America to any Third Partythird party and ImmunoGen shall have no further rights to the Product; provided, that if Liquidia grants such non-exclusive license to however, for a Third Party within nine (9) months after the expiration period of Negotiation Period, then the terms of such Third Party license shall be no less favorable to Liquidia than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” ] after the ROFN Termination Date, Licensee agrees that if the financial terms and conditions offered to such confidential portions third party would, taken as a whole, be materially less favorable to Licensee than the last written offer proposed by ImmunoGen, then Licensee shall so notify ImmunoGen and ImmunoGen shall have been deleted and filed separately with the Securities and Exchange Commission right to send Licensee a new written notice to re-commence negotiations within [***] after receiving Licensee’s notice. If ImmunoGen provides such notice within such time period, the Parties shall negotiate for another [***] period (during which Licensee shall not offer the opportunity to any third party to obtain a license, or enter into an agreement pursuant to Rule 24b-2 which a third party would obtain the right to develop or commercialize the Product in North America) the terms of the Securities Exchange Act of 1934, as amendedImmunoGen Exclusive License based upon the terms and conditions offered to the third party. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products The Parties hereby acknowledge and agree that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokinesneither Party shall have an obligation to enter into an ImmunoGen Exclusive License.

Appears in 2 contracts

Samples: License Agreement (Fusion Pharmaceuticals Inc.), License Agreement (Fusion Pharmaceuticals Inc.)

Right of First Negotiation. If at any time during the Inhaled Option Period and/or Vaccines Option Periodterm of this Agreement SCOLR proposes or intends to enter into any Additional License Opportunity with any Third Party, Liquidia desires to grant a non-exclusive license to its or if SCOLR receives any proposal or indication of interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iii), then it shall first notify GSK and GSK Bio of such desire in writing, describing in reasonable detail the scope of the license it is interested in granting to from a Third Party with respect to any Additional License Opportunity that SCOLR intends to pursue (an “ALO”), SCOLR shall provide written notice to Wyeth of such proposal or intent, along with reasonable details regarding such Additional License Opportunity (such notice from whom Liquidia has received SCOLR to Wyeth referred to as a term sheet or letter of intent (the ROFN RFN Notice”) and GSK and/or GSK Bio thereafter shall have the exclusive ). SCOLR hereby grants to Wyeth a right of first negotiation with respect to obtain each ALO. With respect to each ALO, during the period of [***] from the date of the relevant RFN Notice, SCOLR shall provide to Wyeth all information reasonably requested by Wyeth with respect to such ALO and Wyeth shall inform SCOLR whether Wyeth desires to negotiate an exclusiveagreement between SCOLR and Wyeth relating to such ALO. If Wyeth notifies SCOLR that it desires to negotiate an agreement between SCOLR and Wyeth relating to an ALO, worldwideSCOLR and Wyeth shall in good faith negotiate transaction terms and conditions and an agreement relating to the relevant Additional License Opportunity during the [***] period (or such longer period as may be agreed to by Wyeth and SCOLR) following the date of the notice by Wyeth referred to in clause (a) or (b) above, sublicensable license and during such period SCOLR and its directors, officers, representatives and agents shall discontinue all, and shall not initiate, encourage or engage in any, discussions with any Third Party with respect to Liquidia’s interest such Additional License Opportunity. If Wyeth and SCOLR do not execute an agreement with respect to such Additional License Opportunity despite their good faith efforts to do so in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation period of products time referred to in the applicable field (i.e. a field outside vaccines applications and/or preceding sentence, SCOLR shall be free to enter into an agreement, within [***] after the Inhaled Field)discontinuation of negotiations between SCOLR and Wyeth, for such Additional License Opportunity with one or more Third Parties on terms no less favorable to SCOLR than the terms last offered by SCOLR to Wyeth. GSK In order to keep Wyeth fully informed of potential Additional License Opportunities, SCOLR shall notify Wyeth promptly after becoming aware of any invention, development, license or GSK Bio acquisition that could be the subject of an Additional License Opportunity. In addition to the foregoing, from time to time, SCOLR shall have thirty (30) days from disclose any new technology relating to the receipt modification of the ROFN Notice to inform Liquidia duration of the activity or effectiveness of active pharmaceutical ingredients suitable for use with any product containing ibuprofen or any enantiomer or salt thereof, either alone or in writing combination with one or more of its election to the active ingredients, that SCOLR Controls and, if requested by Wyeth, negotiate the terms of such exclusive license, and another thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice during the first thirty (30) day period and submits the initial proposal within the second thirty (30) day period, Liquidia shall negotiate exclusively in good faith with GSK or GSK Bio, for a period not to exceed six (6) months from GSK’s or GSK Bio’s receipt of Wyeth the ROFN Notice (the “Negotiation Period”), the terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by the end of the Negotiation Period, then Liquidia shall be free to negotiate with any Third Party for a non-exclusive license within the same applicable field that was the subject of negotiations with GSK or GSK Bio, and to grant such non-exclusive license to any Third Party; provided, that if Liquidia grants such non-exclusive license to a Third Party within nine (9) months after the expiration of Negotiation Period, then the terms of such Third Party license shall be no less favorable to Liquidia than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested rights with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokinesthereto.

Appears in 1 contract

Samples: Development and License Agreement (SCOLR Pharma, Inc.)

Right of First Negotiation. If during the Inhaled Option Period and/or Vaccines Option PeriodPerceptive Life Sciences Master Fund, Liquidia desires to grant a non-exclusive license to Ltd. and its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iiiAffiliates (“Perceptive Master Fund”), then it shall first notify GSK and GSK Bio RTW will each have a Right of such desire in writing, describing in reasonable detail the scope of the license it is interested in granting to a Third Party from whom Liquidia has received a term sheet or letter of intent First Negotiation (the ROFN NoticeROFN”) with respect to any future debt financings by the Company. Accordingly, before entering into a debt financing transaction (a “Debt Financing”) with any third party, the Company shall promptly notify Perceptive Master Fund and GSK and/or GSK Bio thereafter RTW in writing that it may pursue such a potential Debt Financing and Perceptive Master Fund and RTW shall each have the exclusive right of first negotiation to obtain an exclusive, worldwide, sublicensable license to Liquidia’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, and any other intellectual property rights five (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio shall have thirty (305) days from the receipt of such notice to provide the Company written notice that it desires to enter into good faith negotiations with the Company regarding the Debt Financing (the “ROFN Option”). If Perceptive Master Fund and RTW do not provide written notice that it is exercising its ROFN Option within such five (5) day period, then the Company shall have no further obligation with respect to the ROFN Notice to inform Liquidia in writing of its election Option and shall be free to negotiate and enter into any Debt Financing with any third party. If Perceptive Master Fund or RTW properly exercises the ROFN Option as described above, then the Parties shall negotiate exclusively, reasonably and in good faith concerning the terms of such exclusive license, and another the Debt Financing for a period of thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive licensedays. If GSK or GSK Bio delivers the parties do not execute and deliver an agreement with respect to the Debt Financing within such notice during the first thirty (30) day period and submits the initial proposal within the second thirty (30) day period, Liquidia shall negotiate exclusively in good faith with GSK or GSK Bio, for a period not to exceed six (6) months from GSK’s or GSK Bio’s receipt of then the ROFN Notice (the “Negotiation Period”), the terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by the end of the Negotiation Period, then Liquidia Company shall be free to negotiate and enter into any Debt Financing with any Third Party for a non-exclusive license within the same applicable field that was the subject of negotiations with GSK or GSK Bio, and to grant such non-exclusive license to any Third Partythird party; provided, provided that if Liquidia grants such non-exclusive license to third party transaction is, when taken as a Third Party within nine (9) months after the expiration of Negotiation Periodwhole, then the terms of such Third Party license shall be no materially and substantially less favorable to Liquidia the Company than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything offered to the contraryCompany by Perceptive Master Fund or RTW, then the licenses that Liquidia may grant Company will provide written notice describing and offering Perceptive Master Fund and RTW such Debt Financing for a period of five (5) days (after Perceptive Master Fund’s and RTW’s receipt of such notice) before entering such Debt Financing with a third party. If Perceptive Master Fund or RTW elects to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-Howpursue such Debt Financing, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) it shall be thereafter excluded from and not subject to this Section 4.3 as deliver written notice to the particular field proposed to GSK. Further, each time Liquidia desires to grant a nonCompany within such 5-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any timeday period, and the right parties will proceed to negotiate and finalize definitive agreements. This Subsection 5 shall automatically terminate and be of first negotiation described in this Section 4.3 shall only apply no further force or effect (a) upon the earlier of (i) the consummation of any Deemed Liquidation Event (as defined in the field Restated Certificate) or (ii) the consummation of prescription pharmaceutical productsthe Company’s first underwritten public offering of its Common Stock, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested or (b) with respect to portions of this agreement a Purchaser, if such Purchaser no long qualifies as indicated by “[***]” and such confidential portions have been deleted and filed separately with a Major Investor (as defined in the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar productsInvestor’s Rights Agreement). For purposes of this Section 4.3, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokines.

Appears in 1 contract

Samples: ’s Rights Agreement (Landos Biopharma, Inc.)

Right of First Negotiation. If during If, at any time prior to the Inhaled Option Period and/or Vaccines Option Periodfifth anniversary of the Effective Date, Liquidia Alnylam desires to grant a non-exclusive license any Third Party rights to its interest Develop and/or Commercialize one or more Licensed Product(s) in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described Field in Section 11.4(b)(iiiany portion of the Licensed Territory (excluding customary distribution arrangements entered into in the ordinary course of business by Alnylam), then it Alnylam shall first notify GSK and GSK Bio Genzyme in writing of its intent. Genzyme shall have [***] days from receipt of such written notice to notify Alnylam in writing as to whether Genzyme desires to negotiate for such rights in such territory, and if Genzyme so notifies Alnylam that it does desire to negotiate for such rights in writingsuch territory, describing in reasonable detail the scope of the license it is interested in granting to a Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice”) and GSK and/or GSK Bio thereafter Genzyme shall have the exclusive right of first negotiation to obtain an exclusive, worldwide, sublicensable license to Liquidia’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio shall have thirty (30) [***] days from the receipt date of the ROFN Notice such notification to inform Liquidia in writing of its election Alnylam to negotiate with Alnylam and to make one or more written non-binding offers to Alnylam concerning the terms acquisition of such rights in such territory by Genzyme. Genzyme shall have the exclusive license, and another thirty right for [***] days (30or such longer period as may be mutually agreed by the Parties) days to submit to Liquidia an initial proposal for the terms of after such exclusive license. If GSK or GSK Bio delivers such notice during the first thirty (30) day period and submits the initial proposal within the second thirty (30) [***] day period, Liquidia shall negotiate exclusively to finalize and enter into a definitive agreement with Alnylam for such rights in good faith with GSK or GSK Bio, for a period not to exceed six (6) months from GSK’s or GSK Bio’s receipt of the ROFN Notice (the “Negotiation Period”), the terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by the end of the Negotiation Period, then Liquidia shall be free to negotiate with any Third Party for a non-exclusive license within the same applicable field that was the subject of negotiations with GSK or GSK Bio, and to grant such non-exclusive license to any Third Party; provided, that if Liquidia grants such non-exclusive license to a Third Party within nine (9) months after the expiration of Negotiation Period, then the terms of such Third Party license shall be no less favorable to Liquidia than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. territory, provided that if either Genzyme does not provide such written notice within such [***] day period or Genzyme does provide such written non-binding offer within such subsequent [***] day period, or Genzyme provides such notice of interest and such confidential portions have been deleted written offer but for any reason Genzyme and filed separately Alnylam do not enter into a definitive agreement within the [***] day negotiation period, Alnylam shall be free to enter into an agreement with the Securities and Exchange Commission pursuant a Third Party(ies) relating to Rule 24b-2 of the Securities Exchange Act of 1934such rights in such territory, as amendedwithout further obligation to Genzyme. basis, or vaccine or biological products (including biosimilar products)[***]. For purposes of this Section 4.3clarity, “biological products” means prior to the exclusive negotiating periods described above, Alnylam shall be free to engage in discussions and exchange information with Third Parties with respect to the applicable Licensed Product(s) rights, but shall not enter into any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokinesbinding agreement with any Third Party with respect to such rights.

Appears in 1 contract

Samples: Exclusive License Agreement (Alnylam Pharmaceuticals, Inc.)

Right of First Negotiation. If If, at any time during the Inhaled Option Period and/or Vaccines Option PeriodTerm, Liquidia Genzyme desires to grant a non-exclusive license any Third Party rights to its interest Develop and/or Commercialize one or more Global Licensed Product(s) in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described Field in Section 11.4(b)(iiiany portion of the Licensed Territory (excluding customary distribution arrangements entered into in the ordinary course of business by Genzyme), then it Genzyme shall first notify GSK and GSK Bio Alnylam in writing of its intent. Alnylam shall have [***] days from receipt of such written notice to notify Genzyme in writing as to whether Alnylam desires to negotiate for such rights in such territory, and if Alnylam so notifies Genzyme that it does desire to negotiate for such rights in writingsuch territory, describing in reasonable detail the scope of the license it is interested in granting to a Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice”) and GSK and/or GSK Bio thereafter Alnylam shall have the exclusive right of first negotiation to obtain an exclusive, worldwide, sublicensable license to Liquidia’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio shall have thirty (30) [***] days from the receipt of the ROFN Notice to inform Liquidia in writing of its election to negotiate the terms date of such exclusive license, and another thirty (30) days notification to submit to Liquidia an initial proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice during the first thirty (30) day period and submits the initial proposal within the second thirty (30) day period, Liquidia shall negotiate exclusively in good faith with GSK or GSK Bio, for a period not to exceed six (6) months from GSK’s or GSK Bio’s receipt of the ROFN Notice (the “Negotiation Period”), the terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by the end of the Negotiation Period, then Liquidia shall be free to negotiate with any Third Party for a non-exclusive license within the same applicable field that was the subject of negotiations with GSK or GSK Bio, and to grant such non-exclusive license to any Third Party; provided, that if Liquidia grants such non-exclusive license to a Third Party within nine (9) months after the expiration of Negotiation Period, then the terms of such Third Party license shall be no less favorable to Liquidia than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. GLOBAL LICENSE TERMS Genzyme to negotiate with Genzyme and to make one or more written non-binding offers to Genzyme concerning the acquisition of such rights in such territory by Alnylam. Alnylam shall have the exclusive right for [***] days (or such longer period as may be mutually agreed by the Parties) after such [***] day period, to finalize and enter into a definitive agreement with Genzyme for such rights in such territory, provided that if either Alnylam does not provide such written notice within such [***] day period or Alnylam does provide such written non-binding offer within such subsequent [***] day period, or Alnylam provides such notice of interest and such confidential portions have been deleted written offer but for any reason Genzyme and filed separately Alnylam do not enter into a definitive agreement within the [***] day negotiation period, Genzyme shall be free to enter into an agreement with a Third Party(ies) relating to such rights in such territory, without further obligation to Alnylam. Genzyme shall not, during the Securities exclusive [***] and Exchange Commission pursuant [***] day negotiating periods described above, enter into discussions, exchange information, or otherwise negotiate with any Third Party with respect to Rule 24b-2 an agreement with respect to the Development and/or Commercialization of the Securities Exchange Act applicable Global Licensed Product(s) in the Field in the Licensed Territory. Notwithstanding the foregoing, during the period of 1934[***] months after the termination of any such negotiation that does not result in a definitive agreement between Alnylam and Genzyme, as amended. basisGenzyme shall not enter into a transaction with respect to such rights in such territory with any Third Party on terms that are, or vaccine or biological products (including biosimilar products)in the aggregate, materially more favorable to the Third Party than the last terms offered in writing by Alnylam to Genzyme unless Genzyme first re-offers such transaction to Alnylam on such more favorable terms and Alnylam does not accept such offer and enter into such transaction with Genzyme within [***] days after such re-offer. For purposes of this Section 4.3clarity, “biological products” means prior to the exclusive negotiating periods described above, Genzyme shall be free to engage in discussions and exchange information with Third Parties with respect to the applicable Global Licensed Product(s) rights, but shall not enter into any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokinesbinding agreement with any Third Party with respect to such rights.

Appears in 1 contract

Samples: Master Agreement (Alnylam Pharmaceuticals, Inc.)

Right of First Negotiation. If during (a) Commencing on the Inhaled Option Period and/or Vaccines Option Period, Liquidia desires to grant a non-exclusive license to its interest Effective Date and ending one hundred and eighty (180) days following the completion of the first Phase 2 clinical trial of first Product in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iii)Zydus Territory (i.e., then it shall first notify GSK and GSK Bio of such desire in writing, describing in reasonable detail the scope of the license it is interested in granting to a Third Party from whom Liquidia has received a term sheet or letter of intent database lock) (the “ROFN NoticePeriod) and GSK and/or GSK Bio thereafter ), Zydus shall have the exclusive first right of first negotiation to obtain negotiate an exclusive, worldwide, sublicensable exclusive license to Liquidiaunder the XOMA Technology and XOMA’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-HowTechnology to Develop, as applicablemake, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having have made, use, sale, offering sell and offer for sale or importation of products the Products in the applicable field XOMA Territory (i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio shall have thirty (30“XOMA Territory License”) days from the receipt of the ROFN Notice to inform Liquidia in writing of its election to negotiate the terms of such exclusive license, and another thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive licenseaccordance with this Section. If GSK or GSK Bio delivers such Zydus provides XOMA with written notice during the first thirty ROFN Period that it wishes to exercise such right (30) day period and submits the initial proposal within the second thirty (30) day perioda “Negotiation Notice”), Liquidia shall negotiate exclusively in good faith with GSK or GSK Bio, then for a period not to exceed six (6) months from GSK’s or GSK Bio[*] days following XOMA’s receipt of the ROFN Notice such notice (the “Negotiation Period”), ) the Parties shall negotiate in good faith the commercially reasonable terms under which Liquidia will grant such exclusive license to GSK or GSK Bioof a XOMA Territory License. If GSK Zydus does not provide a Negotiation Notice to XOMA during the ROFN Period, or GSK Bio if Zydus provides a Negotiation Notice during the ROFN Period and Liquidia fail to reach the Parties do not execute a binding written definitive agreement for the exclusive license XOMA Territory License within the Negotiation Period (each, a “ROFN Termination”), then XOMA shall have the right to grant licenses to one or more Third Parties to Develop, make, have made, use, sell and offer for sale the Products in the XOMA Territory (each such Third Party, a “XOMA Partner”), subject to XOMA’s payment obligations to Zydus as set forth in Section ‎7.3. If Zydus provided XOMA with a Negotiation Notice during the Negotiation Period, then notwithstanding the foregoing, for [*] -16 of 63- [*] = Certain information contained in this document, marked by brackets, has been omitted because it is both not material and would be competitively harmful if publicly disclosed. months following the end expiration of the Negotiation Period XOMA shall not grant a XOMA Territory License to any Third Party on terms that are materially less favorable to XOMA, taken as a whole, then the terms last offered in writing by Zydus. If after [*] months of the expiration of the Negotiation Period, then Liquidia shall be free to negotiate XOMA has not entered into a license agreement with any Third Party for a non-exclusive license within the same applicable field that was the subject of negotiations with GSK or GSK Bio, and to grant such non-exclusive license to any Third Party; provided, that if Liquidia grants such non-exclusive license to a Third Party within nine (9) months after the expiration of Negotiation Period, then the terms of such Third Party license shall be no less favorable to Liquidia than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and the Products in the XOMA Territory, then in such confidential portions have been deleted and filed separately with case, at Zydus’ request, the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products that cause Parties shall discuss in good faith terms on which Zydus may obtain a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokinesXOMA Territory License.

Appears in 1 contract

Samples: Collaboration and License Agreement (XOMA Corp)

Right of First Negotiation. If during During the Inhaled Option Period and/or Vaccines Option Term and subsequent to the ROFR Offer Period, Liquidia desires if Five Prime determines that it wishes to grant a nonout-exclusive license the right to its interest commercialize the Five Prime CSF1R Program in any territory, Five Prime will inform BMS in writing of same and the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How territory as described in Section 11.4(b)(iii), then it shall first notify GSK and GSK Bio of such desire in writing, describing in reasonable detail the scope of to which the license it is interested in granting will cover. BMS will have an exclusive right to negotiate, for a Third Party from whom Liquidia has received a term sheet or letter period of intent three (3) months thereafter, to obtain exclusive rights to develop and commercialize the Five Prime CSF1R Program for such territory (the “ROFN NoticeNegotiation Period) ). During the ROFN Negotiation Period, if requested by BMS, Five Prime will disclose to BMS all material information and GSK and/or GSK Bio thereafter results relating to the Five Prime CSF1R Program as promptly as practicable after such information and results become available. Any such information and results shall have be treated as Confidential Information of Five Prime hereunder. Notwithstanding the exclusive foregoing, the ROFN Negotiation Period shall be extended for any period during which Five Prime has not complied with its obligations in the preceding sentence. If the original notice is not for a worldwide license, then BMS’s rights shall remain in effect with respect to the territory not covered by the original notice if Five Prime subsequently determines to expand the territory of the license. If BMS does not exercise its right of first negotiation for such rights to obtain the Five Prime CSF1R Program or if an exclusive, worldwide, sublicensable license to Liquidia’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, agreement is not reached between BMS and any other intellectual property Five Prime for such rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio shall have thirty (30) days from the receipt of within the ROFN Notice to inform Liquidia in writing of its election to negotiate the terms of such exclusive license, and another thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice during the first thirty (30) day period and submits the initial proposal within the second thirty (30) day period, Liquidia shall negotiate exclusively in good faith with GSK or GSK Bio, for a period not to exceed six (6) months from GSK’s or GSK Bio’s receipt of the ROFN Notice (the “Negotiation Period”), the terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by the end of the Negotiation Period, then Liquidia shall Five Prime will be free to negotiate with out-license any Third Party for a non-exclusive license within the same applicable field that was the and all rights (subject of negotiations with GSK or GSK Bio, and to grant such non-exclusive license to any Third Party; provided, that if Liquidia grants such non-exclusive license to a Third Party within nine (9) months after the expiration of Negotiation Period, then the terms of such Third Party license shall be no less favorable to Liquidia than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything this Agreement) to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all Five Prime CSF1R Program for such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSKterritory. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule * INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 of the Securities Exchange Act of PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, as amendedAS AMENDED. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokines.EXECUTION VERSION

Appears in 1 contract

Samples: Clinical Trial Collaboration Agreement (Five Prime Therapeutics Inc)

Right of First Negotiation. If during at any time prior to the Inhaled Option Period and/or Vaccines Option Periodtenth anniversary of the Effective Time, Liquidia desires (A) FMC or any Affiliate of FMC shall develop any new technology, whether patented or a trade secret (such party developing such new technology, hereinafter referred to grant a non-exclusive license to its interest in as the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iii“inventor”), then it and the Inventor intends to sell or license such technology to a third party for applications in, or with a material special relationship to, Nutritional Substances and/or Pharmaceutical Substances outside of the Renal Business, the Inventor shall first notify GSK advise FAG of its intent to sell or license such technology and GSK Bio shall negotiate with FAG in good faith for the purpose of agreeing with FAG on either terms of a sale to FAG of such desire in writing, describing in reasonable detail technology or of a license granting FAG rights to use such technology for the scope commercialization of Nutritional Substances and/or Pharmaceutical Substances outside of the license it is interested in granting Renal Business. If the Inventor and FAG are unable to a Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice”) and GSK and/or GSK Bio thereafter shall have the exclusive right of first negotiation to obtain an exclusive, worldwide, sublicensable license to Liquidia’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio shall have thirty (30) days from the receipt of the ROFN Notice to inform Liquidia in writing of its election to negotiate the agree on mutually satisfactory terms of such exclusive sale or license, and another thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice during the first thirty (30) day period and submits the initial proposal within the second thirty (30) day period, Liquidia shall negotiate exclusively in good faith with GSK or GSK Bio, for a period not to exceed six (6) months from GSK’s or GSK Bio’s receipt of the ROFN Notice (the “Negotiation Period”), the terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by the end of the Negotiation Period, then Liquidia shall be free to negotiate with any Third Party for a non-exclusive license within the same applicable field that was the subject of negotiations with GSK or GSK Bio, and to grant such non-exclusive license to any Third Party; provided, that if Liquidia grants such non-exclusive license to a Third Party within nine (9) months after the expiration of Negotiation Period, then the terms of such Third Party license shall be no less favorable to Liquidia than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during after good faith negotiations, FAG shall have no further rights in or to such technology and the Inhaled Collaboration Term Inventor shall be free to sell or Vaccine Collaboration Termlicense such technology to third parties free and clear of any rights of FAG therein; (B) FAG or any Affiliate of FAG shall develop any new technology, whether patented or a trade secret (such party developing such new technology, hereinafter referred to as the “inventor”), and the Inventor intends to sell or license such technology to a third party for applications in, or with a material special relationship to, the Renal Business, the Inventor shall first advise FMC of its intent to sell or license such technology and shall negotiate with FMC in good faith for the purpose of agreeing with FMC on either terms of a sale to FMC of such technology or of a license granting FMC rights to use such technology in the Real Business. If the Inventor and FMC are unable to agree on mutually satisfactory terms of such sale or license, as the case may be, including after good faith negotiations, FMC shall have no further rights in or to such technology and the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia Inventor shall be free to grant non-exclusive licenses sell or license such technology to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field third parties free and clear of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right rights of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokinesFMC therein.

Appears in 1 contract

Samples: Closing Covenant Agreement (Fresenius Medical Care AG & Co. KGaA)

Right of First Negotiation. If during Fulcrum or any of its Affiliates intend to enter into any confidential discussions with a Third Party with respect to the Inhaled Option Period and/or Vaccines Option Periodlicense, Liquidia desires sale, assignment or other transfer or grant of rights (other than, in each case, the transfer or grant of solely subcontracting rights) to grant such Third Party to Research, Develop, or Commercialize any Licensed Compound or Licensed Product in the Field in the Fulcrum Territory, then, prior to entering into a non-exclusive license disclosure agreement with such Third Party, Fulcrum shall provide to its interest in Sanofi written notice of the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iii), then it shall first notify GSK and GSK Bio of such desire in writing, describing in reasonable detail the proposed scope of the license it is interested in granting Research, Development or Commercialization rights that Fxxxxxx proposes to a grant to such Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice”) and GSK and/or GSK Bio thereafter shall ). Thereafter, Sanofi will have an exclusive right, exercisable no later than [***] after receipt of any such ROFN Notice from Fulcrum, to notify Fulcrum in writing as to whether Sanofi desires to negotiate for such rights to Research, Develop or Commercialize the exclusive right of first negotiation to obtain an exclusive, worldwide, sublicensable license to Liquidia’s interest Licensed Compounds or Licensed Products in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, and any other intellectual property rights Fulcrum Territory (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field“ROFN Exercise Notice”). GSK or GSK Bio shall If Sanofi provides a ROFN Exercise Notice to Fulcrum within such [***] period, then Sanofi will have thirty (30) days a one-time right for [***] from the receipt date of the ROFN Notice to inform Liquidia in writing of its election to negotiate the terms of such exclusive license, and another thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice during the first thirty (30) day period and submits the initial proposal within the second thirty (30) day period, Liquidia shall negotiate exclusively in good faith with GSK or GSK Bio, for a period not to exceed six (6) months from GSK’s or GSK BioFulcrum’s receipt of the ROFN Notice (the “ROFN Negotiation Period”), ) to require the Parties to exclusively negotiate in good faith the terms under of a definitive agreement (or amendment to this Agreement) pursuant to which Liquidia will Fulcrum would grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for Sanofi the exclusive license by rights to Research, Develop or Commercialize the end of Licensed Compounds or Licensed Products in the Fulcrum Territory, and (b) upon Sanofi’s request during the ROFN Negotiation Period, (i) Fulcrum will provide Sanofi with all information and documentation reasonably requested by Sanofi in Fulcrum’s or its Affiliate’s possession and Control relating to the Licensed Compounds or Licensed Products in the Fulcrum Territory and (ii) afford Sanofi and its representatives reasonable access during normal business hours to Fulcrum’s personnel reasonably designated by Fulcrum to address Sanofi’s inquiries. Neither Party will have any obligation to enter into any agreement or amendment to this Agreement granting rights to Sanofi to Research, Develop or Commercialize the Licensed Compounds or Licensed Products in the Fulcrum Territory. If the ROFN Negotiation Period expires before the Parties have entered into an agreement or amendment to this Agreement with respect to Sanofi’s Research, Development or Commercialization of the Licensed Compounds or Licensed Products in the Fulcrum Territory, then Liquidia shall Fulcrum will have no further obligation to negotiate with Sanofi with respect to any grant of such rights to Sanofi and, for a period of [***], will be free to negotiate and enter into an agreement with any Third Party for with respect to a non-exclusive license within grant of rights to Research, Develop or Commercialize the same applicable field Licensed Compounds or Licensed Products in the Fulcrum Territory, provided that was (x) any transaction that is the subject of such negotiations and agreement with GSK one or GSK Bio, more Third Parties shall not exceed the scope of Development and to grant such non-Commercialization rights described in the applicable ROFN Notice; (y) Sanofi’s exclusive license negotiation rights under this Section 2.8 (Right of First Negotiation) shall remain in effect with respect to any Third Partynegotiations by Fulcrum in respect of the Licensed Compounds or Licensed Products for transactions of a different scope; provided, that and (z) if Liquidia grants such non-exclusive license Fulcrum or its Affiliates fail to a Third Party within nine (9) months after the expiration of Negotiation Period, then the terms of enter into any such Third Party license shall be no less favorable to Liquidia than agreement during such [***] period, following expiration of such [***], Sanofi would again have the terms last proposed by GSK or GSK Bio to Liquidiaright of first negotiation for such rights in accordance with the provisions of this Section 2.8 (Right of First Negotiation). Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described contrary in this Section 4.32.8 (Right of First Negotiation), either a Change of Control of Fulcrum or its Affiliates will not trigger Fulcrum’s obligation to the same Third Party or provide a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokinesROFN Notice.

Appears in 1 contract

Samples: Collaboration and License Agreement (Fulcrum Therapeutics, Inc.)

Right of First Negotiation. If during Depomed shall notify Santarus in writing in the Inhaled Option Period and/or Vaccines Option Period, Liquidia event that Depomed desires to grant a non-exclusive divest itself of its rights to the Product in the Territory (e.g., by asset sale or product license to its interest in the Joint Inhaled Collaboration Know-How a Third Party) or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iii), then it shall first notify GSK and GSK Bio of such desire in writing, describing in reasonable detail the scope of the license it is interested in granting to grant rights to a Third Party from whom Liquidia has received to develop or commercialize a term sheet or letter pharmaceutical product containing metformin and another generic active pharmaceutical ingredient (i.e., an active pharmaceutical ingredient that is produced and distributed within the Territory without composition of intent matter patent protection for the compound) in combination with Depomed’s proprietary AcuForm drug delivery technology incorporated within the Products (a “Combination Product”). If Santarus notifies Depomed in writing within [***] days after receipt of such notice (the “ROFN NoticeEvaluation Period”) that Santarus is not interested in obtaining all of Depomed’s rights in and GSK and/or GSK Bio thereafter to the Products or the applicable Combination Product (such rights, “Metformin Product Rights”), or if Santarus fails to notify Depomed of Santarus’ interest in obtaining the Metformin Product Rights, in either case prior to the expiration of the Evaluation Period, then Depomed shall have no further obligation to Santarus under this Agreement with respect to the exclusive right applicable Metformin Product Rights. If Santarus is interested in obtaining the Metformin Product Rights, it Confidential Information, indicated by [***] has been omitted from this filing and filed separately with the Securities Exchange Commission shall so notify Depomed in writing prior to the expiration of first negotiation to obtain an exclusive, worldwide, sublicensable license to Liquidia’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicableEvaluation Period, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio shall have thirty (30) days from the upon Depomed’s receipt of the ROFN Notice to inform Liquidia in writing of its election to negotiate the terms of such exclusive license, and another thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice during the first thirty (30) day period Santarus and submits the initial proposal within the second thirty (30) day period, Liquidia Depomed shall negotiate exclusively in good promptly commence good-faith with GSK or GSK Bionegotiations, for a period not to exceed six (6) months from GSK’s or GSK Bio’s receipt of [***] days and such longer period as may be mutually agreed upon by the ROFN Notice parties in writing in the event the parties have made material progress in the negotiations (the “Negotiation Period”), regarding the commercially reasonable terms under of an agreement pursuant to which Liquidia will grant such exclusive license to GSK or GSK BioSantarus shall obtain the Metformin Product Rights. If GSK or GSK Bio Depomed and Liquidia Santarus fail to reach a binding written enter into an agreement for the exclusive license by Metformin Product Rights prior to the end expiration of the Negotiation Period, then Liquidia Depomed shall be free thereafter have the right to negotiate and enter into an agreement with any a Third Party for granting the Metformin Product Rights to a non-exclusive license within the same applicable field that was the subject of negotiations with GSK or GSK Bio, and to grant such non-exclusive license to any Third Party; providedprovided that, that if Liquidia grants such non-exclusive license to for a Third Party within nine (9) months after the expiration period of Negotiation Period, then the terms of such Third Party license shall be no less favorable to Liquidia than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***], any such agreement may not be on terms and such confidential portions have been deleted conditions materially more favorable to the Third Party than the terms and filed separately conditions last offered by Santarus prior to the termination of discussions with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amendedDepomed. basis, or vaccine or biological products (including biosimilar products). For purposes The provisions of this Section 4.313.1 shall not apply to, and Depomed shall have no obligation to Santarus under this Section 13.1 in respect of, any acquisition of Depomed by a Third Party, any merger or consolidation with or involving Depomed, any acquisition by a Third Party of any material portion of the stock of Depomed, or any acquisition by a Third Party of a material portion of the assets of Depomed in addition to the Products or any Combination Product (biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokinesMerger Transaction”).

Appears in 1 contract

Samples: Promotion Agreement (Depomed Inc)

Right of First Negotiation. If during If, at any time prior to the Inhaled Option Period and/or Vaccines Option Period[***], Liquidia Genzyme desires to grant a non-exclusive license any Third Party rights to its interest Develop and/or Commercialize one or more Global AT3 Licensed Product(s) in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described Field in Section 11.4(b)(iiiany portion of the Licensed Territory (excluding customary distribution arrangements entered into in the ordinary course of business by Genzyme), then it Genzyme shall first notify GSK and GSK Bio Alnylam in writing of its intent. Alnylam shall have [***] days from receipt of such written notice to notify Genzyme in writing as to whether Alnylam desires to negotiate for such rights in such territory, and if Alnylam so notifies Genzyme that it does desire to negotiate for such rights in writingsuch territory, describing in reasonable detail the scope of the license it is interested in granting to a Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice”) and GSK and/or GSK Bio thereafter Alnylam shall have the exclusive right of first negotiation to obtain an exclusive, worldwide, sublicensable license to Liquidia’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio shall have thirty (30) [***] days from the receipt date of the ROFN Notice such notification to inform Liquidia in writing of its election Genzyme to negotiate with Genzyme and to make one or more written non-binding offers to Genzyme concerning the terms acquisition of such rights in such territory by Alnylam. Alnylam shall have the exclusive license, and another thirty right for [***] days (30or such longer period as may be mutually agreed by the Parties) days to submit to Liquidia an initial proposal for the terms of after such exclusive license. If GSK or GSK Bio delivers such notice during the first thirty (30) day period and submits the initial proposal within the second thirty (30) [***] day period, Liquidia shall negotiate exclusively to finalize and enter into a definitive agreement with Genzyme for such rights in good faith with GSK such territory, provided that if Confidential ACTIVE/100404760.2 Amended and Restated ALN-AT3 Global License Terms either Alnylam does not provide such written notice within such [***] day period or GSK BioAlnylam does provide such written non-binding offer within such subsequent [***] day period, or Alnylam provides such notice of interest and such written offer but for any reason Genzyme and Alnylam do not enter into a period not to exceed six (6) months from GSK’s or GSK Bio’s receipt of definitive agreement within the ROFN Notice (the “Negotiation Period”)[***] day negotiation period, the terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by the end of the Negotiation Period, then Liquidia Genzyme shall be free to negotiate enter into an agreement with a Third Party(ies) relating to such rights in such territory, without further obligation to Alnylam. [***] For clarity, prior to the exclusive negotiating periods described above, Genzyme shall be free to engage in discussions and exchange information with Third Parties with respect to the applicable Global AT3 Licensed Product(s) rights, but shall not enter into any binding agreement with any Third Party for a non-exclusive license within the same applicable field that was the subject of negotiations with GSK or GSK Bio, and to grant such non-exclusive license to any Third Party; provided, that if Liquidia grants such non-exclusive license to a Third Party within nine (9) months after the expiration of Negotiation Period, then the terms of such Third Party license shall be no less favorable to Liquidia than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokinesrights.

Appears in 1 contract

Samples: Global License Terms (Alnylam Pharmaceuticals, Inc.)

Right of First Negotiation. If during Parent will provide Seller a written notice (an “Initial Notice”) of each Marketing Approval (or a similar or an equivalent approval) by the Inhaled Option Period and/or Vaccines Option PeriodEuropean Medicines Agency or the Brazilian Health Surveillance Agency (or a similar, Liquidia desires equivalent or successor Governmental Body) for a particular indication of any Lixivaptan Product (each such particular indication (an “Approved Indication”)) in any portion of Europe, Brazil, Russia or the Commonwealth of Independent States (the “ROFN Territory”) within ten (10) days of receipt of such approval. Parent Parties hereby grant Seller and any Affiliates designated by Seller for such purpose (together, “Chiesi”) a right of first negotiation to grant a non-negotiate exclusive license rights to its interest commercialize any and all Lixivaptan Products for the Approved Indication in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described ROFN Territory identified in Section 11.4(b)(iii)an Initial Notice, then it shall first notify GSK and GSK Bio Chiesi must provide Parent with written notice of its exercise of such desire in writing, describing in reasonable detail the scope right of the license it is interested in granting to first negotiation (a Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice”) and GSK and/or GSK Bio thereafter shall have the exclusive right of first negotiation to obtain an exclusive, worldwide, sublicensable license to Liquidia’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio shall have within thirty (30) days from the receipt of the date on which it receives an Initial Notice; provided, however, that if Chiesi does not provide Parent with a ROFN Notice to inform Liquidia in writing of its election to negotiate the terms of within such exclusive license, and another thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice during the first thirty (30) day period and submits the initial proposal within the second thirty (30) day period, Liquidia Section 5.2 shall negotiate exclusively in be void and of no further force and effect with respect to the Lixivaptan Product Approved Indication for the ROFN Territory. During the applicable ROFN Term, Chiesi and Parent will promptly and diligently, on an exclusive and good faith with GSK or GSK Biobasis, negotiate commercially reasonable terms for a period not an exclusive commercial agreement for the Lixivaptan Product Approved Indication in the ROFN Territory. Prior to exceed six (6) months from GSK’s or GSK Bio’s receipt the expiration of the applicable ROFN Notice Term, and subject to the terms of Section 5.2, Parent, directly or indirectly, including through its Affiliates and their respective Representatives, will not negotiate or enter into any commercialization or similar agreement with any third party with respect to any Lixivaptan Product for the ROFN Territory. If Chiesi does not timely deliver a ROFN Notice, Parent may negotiate and enter into definitive agreements with a third party (the Negotiation PeriodThird Party Partner”), and Chiesi will have no further rights with respect to the terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement Lixivaptan Product Approved Indication for the exclusive license by the end ROFN Territory, but shall retain a right of the Negotiation Period, then Liquidia shall be free to negotiate first negotiation with any Third Party for a non-exclusive license within the same applicable field that was the subject of negotiations with GSK or GSK Bio, and to grant such non-exclusive license respect to any Third Party; provided, other Lixivaptan Product indication except to the extent that if Liquidia grants such non-exclusive license to a Third Party within nine (9the definitive agreement(s) months after the expiration of Negotiation Period, then the terms of with such Third Party license shall be no less favorable Partner obligate Parent to Liquidia than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a provide such Third Party Partner with a right of first negotiation, right of first refusal or similar rights in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-Howsuch ROFN Territory with respect to any additional Approved Indication, as the in which case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in refusal of Chiesi pursuant to this Section 4.3 5.1 and Section 5.2 shall only apply be subordinated in the field all respects to such right of prescription pharmaceutical productsfirst negotiation, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions right of this agreement as indicated by “[***]” and first refusal or similar rights of such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokinesThird Party Partner.

Appears in 1 contract

Samples: Stock Purchase Agreement (Centessa Pharmaceuticals LTD)

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Right of First Negotiation. If during During the Inhaled Option Period and/or Vaccines Option Period, Liquidia desires to grant a non-exclusive license to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iii), then it shall first notify GSK and GSK Bio of such desire in writing, describing in reasonable detail the scope two years of the license it is interested in granting Term of this Agreement, AspenBio grants to Merial a Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice”) and GSK and/or GSK Bio thereafter shall have the exclusive right of first negotiation to obtain an exclusivedistribute, worldwidemarket and sell all future animal health products developed by AspenBio ("Right of First Negotiation"). AspenBio shall notify Merial of future animal health products it intends to develop, sublicensable license distribute, market, and sell ("Product Notice"). Within ten business days of a request by AspenBio, and prior to Liquidia’s disclosure of any information regarding such future animal health products, Merial shall sign a confidentiality agreement whereby Merial agrees to maintain in confidence and not to use any information relating to such animal health products disclosed by AspenBio. To exercise the Right of First Negotiation, Merial shall provide AspenBio with notice of its interest in pursuing negotiations ("Notice of Interest") within 60 days of receipt of any Product Notice from AspenBio. In the Joint Inhaled Collaboration Knowevent that Merial does not enter into a confidentiality agreement in such time period, the Right of First Negotiation shall terminate immediately. The Notice of Interest shall be accompanied by a non-How or Joint Vaccines Collaboration Know-How, as applicable, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful refundable payment of $50,000 to AspenBio to exercise the Right of First Negotiation granted under this Section 3.5 for the making, having made, use, sale, offering for sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio shall have thirty (30) 30 days from the receipt Notice of Interest. Upon the ROFN Notice to inform Liquidia in writing of its election to negotiate the terms expiration of such exclusive license, and another thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice during the first thirty (30) day period and submits the initial proposal within the second thirty (30) -day period, Liquidia Merial may extend the Right of First Negotiation granted under this Section 3.5 for up to two additional 30-day periods by making an additional non-refundable payment of $50,000 for each such 30-day extension prior to the expiration of the Right of First Negotiation. After timely receipt of a Notice of Interest and the non-refundable payment or payments described above, AspenBio shall not enter into negotiations with any third parties while the Right of First Negotiation is in effect, provided, that the Right of First Negotiation may not be extended for more than 90 days following the date of receipt of a Notice of Interest (the "Negotiation Period") and during such Negotiation Period AspenBio and Merial each shall negotiate exclusively in good faith with GSK faith. In the event that Merial does not deliver a timely Notice of Interest or GSK Bio, for a period not no final agreement is consummated prior to exceed six (6) months from GSK’s or GSK Bio’s receipt of the ROFN Notice (the “Negotiation Period”), the terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by the end expiration of the Negotiation Period, then Liquidia AspenBio shall be free to negotiate and enter into agreements with any Third Party for a non-exclusive license within the same applicable field that was the subject of negotiations with GSK third parties to distribute or GSK Bio, and to grant market such non-exclusive license to any Third Party; provided, that if Liquidia grants such non-exclusive license to a Third Party within nine (9) months after the expiration of Negotiation Period, then the terms of such Third Party license shall be no less favorable to Liquidia than the terms last proposed by GSK or GSK Bio to Liquidiaanimal health product. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described Nothing in this Section 4.3, either 3.5 shall prevent AspenBio from conducting additional research and testing and market research and analysis (alone or in conjunction with third parties) prior to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on termination of the terms set forth Right of First Negotiation described above. Subject This Section 3.5 shall not apply to Section 4.4 below, Liquidia shall be free animal health products for which AspenBio receives a proposal to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basisdevelop for, or biological products (including biosimilar products) at any timeco-develop with, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokinesindependent third parties.

Appears in 1 contract

Samples: Distribution Agreement (Aspenbio Inc)

Right of First Negotiation. If In the event that GPC Biotech Controls any Derivative Compound during the Inhaled term of this Agreement for which there is clinical data demonstrating efficacy, GPC Biotech shall provide to Licensee written notice thereof (each, a “Compound Option Period and/or Vaccines Option Period, Liquidia desires to grant a non-exclusive license to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iiiNotice”), then it shall first notify GSK and GSK Bio of such desire in writing, describing in reasonable detail the scope of the license it is interested in granting to a Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice”) and GSK and/or GSK Bio thereafter Licensee shall have the an exclusive option and right of first negotiation to obtain an exclusive, worldwide, sublicensable license rights to Liquidia’s interest Commercialize such Derivative Compound in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products Licensee Territory in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio shall have Field by giving written notice to GPC Biotech within thirty (30) days from the after Licensee’s receipt of the ROFN Notice such Compound Option Notice. If Licensee fails to inform Liquidia provide timely written notice of its desire to Commercialize such Derivative Compound, or notifies GPC Biotech in writing of its election that Licensee does not desire to acquire such rights and obligations, then GPC Biotech shall have the right to enter into an agreement with a Third Party to Commercialize and otherwise Exploit such Derivative Compound, without any further obligation to negotiate the terms with Licensee, or provide to Licensee a right of such exclusive licensenegotiation, and another thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive licensewith respect thereto. If GSK or GSK Bio delivers such Licensee provides timely written notice during of interest, then the first thirty (30) day period and submits the initial proposal within the second thirty (30) day period, Liquidia Parties shall negotiate exclusively in good faith with GSK or GSK Biorespect to the foregoing, but neither Party shall have any obligation to enter into any agreement unless they are able to agree on mutually acceptable terms and conditions at such time. In the event the Parties are unable to conclude such an agreement within [...***...] after receipt by GPC Biotech of Licensee’s written notice of interest, Licensee shall provide to GPC Biotech a detailed written summary of the terms on which Licensee would have been prepared to conclude such agreement. If Licensee indicates in writing at such time to GPC Biotech that Licensee desires to continue negotiations with GPC Biotech, the Parties shall continue to negotiate in good faith, provided that GPC Biotech shall be free from and after the end of such [...***...] negotiation period to negotiate and enter into agreements with Third Parties; provided, further that, for a period not to exceed six (6) months from GSK’s or GSK Bio’s receipt of the ROFN Notice (the “Negotiation Period”), the terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by [...***...] after the end of the Negotiation Periodsuch [...***...] negotiation period, then Liquidia GPC Biotech shall be free to negotiate with not enter into any Third Party for a non-exclusive license within the same applicable field that was the subject of negotiations with GSK or GSK Bio, and to grant such non-exclusive license to agreement on any Third Party; provided, that if Liquidia grants such non-exclusive license to a Third Party within nine (9) months after the expiration of Negotiation Period, then the terms of such Third Party license shall be no less favorable to Liquidia GPC Biotech, when taken as a whole, than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms those set forth above. Subject in Licensee’s written offer to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokinesGPC Biotech.

Appears in 1 contract

Samples: Development and License Agreement (Pharmion Corp)

Right of First Negotiation. If during the Inhaled Option Period and/or Vaccines Option PeriodCypress shall be permitted, Liquidia desires subject to grant a non-exclusive license this Section 2.4, to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iii)develop, then it shall first notify GSK and GSK Bio of such desire in writingmake, describing in reasonable detail the scope of the license it is interested in granting to a Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice”) and GSK and/or GSK Bio thereafter shall have the exclusive right of first negotiation to obtain an exclusive, worldwide, sublicensable license to Liquidia’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, salesell, offering offer for sale and import any Cypress Analogs, but not any Cypress Formulations, for any indication and this Agreement shall not include any rights with respect to Cypress Compounds or importation of products in any Information or Patents that pertain to the applicable field Cypress Compounds. Beginning upon the Effective Date and ending [...***...] (i.e. a field outside vaccines applications and/or the Inhaled Field"Exclusive Period"). GSK or GSK Bio , Forest shall have thirty (30) days from a first right to negotiate with Cypress to obtain a license to further develop and commercialize Cypress Compounds for all indications to the receipt extent Forest has not exercised the Option with respect to such Cypress Compounds. In the event Cypress desires to enter into a license arrangement for further development or commercialization of the ROFN Notice any Cypress Analog in any indication or plans to inform Liquidia further develop or commercialize any Cypress Analog itself, before entering into discussions with any Third Party with respect to such license or commencing such activities itself, Cypress will notify Forest in writing of its election desire. Forest may then elect, by providing written notice to negotiate the terms of such exclusive licenseCypress, and another thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice during the first thirty (30) day period and submits the initial proposal within the second thirty (30) day period, Liquidia shall negotiate exclusively in enter into good faith negotiations with GSK or GSK Bio, Cypress with respect to such license for a period of 90 days following notice to Forest. In addition, Forest may provide written notice to Cypress at any time of its desire to negotiate a license arrangement for further development or commercialization of any Cypress Compound in any indication for a period of 90 days following notice to Cypress. If Cypress and Forest do not enter into an agreement with respect to exceed six such license during such 90 day period (6) months from GSK’s or GSK Bio’s receipt of such longer period agreed to in writing by the ROFN Notice (the “Negotiation Period”parties), the terms Cypress will be under which Liquidia no further obligation to negotiate a license with respect to such Cypress Compound, and, if such Cypress Compound is a Cypress Analog, Cypress will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by the end of the Negotiation Period, then Liquidia shall be free to further develop and commercialize, or to negotiate and enter into an agreement with any Third Party with regard to further development and commercialization of, such Cypress Analog in any indication on any terms, subject to the last sentence of this Section 2.4(e). In addition, in the event a Cypress Analog is commercialized by Cypress or a sublicensee during the Exclusive Period, Cypress shall pay to Forest, a royalty of [...***...] on net sales of such Cypress Analog by Cypress or any Third Party to whom Cypress grants a license to such Cypress Analog; provided that such royalty rate may be reduced by written agreement of Cypress and Forest after good faith negotiations to account for a non-exclusive license within the same applicable field any royalty payments that was the subject of negotiations with GSK Cypress or GSK Bio, and to grant such non-exclusive license its sublicensees must make to any Third Party; providedParties with respect to such Cypress Analog. Such royalty shall be payable for the Exclusive Period, but in any event, the payment term shall not be less than [...***...]. With respect to any good faith negotiations regarding a license arrangement for any Cypress Compounds under this Section 2.4(e), the parties agree that if Liquidia grants such non-exclusive license the fair market value of the rights subject to a negotiation shall be determined solely in respect of the incremental value of the marketing of the Cypress Compounds in question over and above the value of any Licensed Product then being marketed in the Licensed Territory by Forest and excluding value attributable to the conversion of sales of Licensed Product then being marketed to the Cypress Compounds in question. In addition, any agreement entered into by Cypress with any Third Party within nine (9) months after with respect to the expiration development or commercialization of Negotiation Period, then the any such Cypress Analog shall not be on principal financial terms of more favorable to such Third Party license shall be no less favorable to Liquidia than the then those principal financial terms last proposed offered by GSK or GSK Bio Cypress to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokinesForest.

Appears in 1 contract

Samples: License and Collaboration Agreement (Cypress Bioscience Inc)

Right of First Negotiation. If during (a) If, following the Inhaled Option Period and/or Vaccines Option PeriodEffective Date, Liquidia desires to grant Alfacell determines that a particular Modified Targeted Ranpirnase compound demonstrates activity across one or more tumor cell types and has commercial viability (and such determination is reasonably supported by reasonable non-exclusive license to its interest clinical or pre-clinical data in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iiirespect of such cell type(s)), then it shall first notify GSK and GSK Bio Alfacell shall, prior to instituting any Phase III development program in respect thereof, provide Par with a one time written notice of such desire in writing, describing in reasonable detail the scope of the license it is interested in granting to information that Alfacell possesses or that Alfacell has a Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice”) and GSK and/or GSK Bio thereafter shall have the exclusive contractual right of first negotiation to obtain an exclusive, worldwide, sublicensable license to Liquidia’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio shall have thirty (30) days from the receipt of the ROFN Notice to inform Liquidia in writing of its election to negotiate the terms of such exclusive license, and another thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice during the first thirty (30) day period and submits the initial proposal within the second thirty (30) day period, Liquidia shall negotiate exclusively in good faith with GSK or GSK Bio, for a period not to exceed six (6) months from GSK’s or GSK Bio’s receipt of the ROFN Notice (the “Negotiation Period”), the terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by the end of the Negotiation Period, then Liquidia shall be free to negotiate with any Third Party to obtain, subject to any corresponding contractual obligation, including copies of such data, and an estimate of the cost for developing and obtaining regulatory approval therefor, that is reasonably required by Par to determine whether or not to enter into negotiations for a non-license agreement with Alfacell with respect to such Modified Targeted Ranpirnase. The delivery of such notice shall automatically grant to Par an exclusive license within option (the same applicable field that was the subject of negotiations “Option”) to enter into an agreement with GSK or GSK Bio, and to grant such non-Alfacell for an exclusive license to permit Par to market, sell and have sold such Modified Targeted Ranpirnase in respect of the applicable indications (the “New License Agreement”). Par shall determine and notify Alfacell of its determination in writing, as soon as practicable, and in any Third Party; provided, that if Liquidia grants such non-exclusive license to a Third Party within nine (9) months event no more than *** after the expiration of Negotiation Period, then the terms grant of such Third Party license shall be no less favorable Option by Alfacell, to Liquidia than (i) exercise the terms last proposed Option by GSK or GSK Bio delivery of written notice to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date Alfacell of the ROFN Notice, and all its exercise of such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basisOption, or biological products (including biosimilar productsii) at any timereject the Option. The exercise, and the right or determination not to exercise, by Par of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription its rights under Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted information omitted and filed separately with the Securities and Exchange Commission Commission. Asterisks denote such omission. this Section 4.5(a) in respect of any granted Option shall not affect its rights in respect of any other Modified Targeted Ranpirnase compound that was not subject to such Option. Any data or other information provided by Alfacell to Par pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, this Section 4.5(a) shall be deemed and treated as amendedConfidential Information in accordance with and subject to Section 8.1. basisIf Par fails to exercise its Option within such ***, or vaccine if Par rejects its Option, or biological products if the Parties do not execute a New License Agreement despite their good faith efforts during the *** described in subsection (including biosimilar productsb) below, then within ten (10) business days after such failure, rejection or absence of execution (as applicable). For purposes , Par shall return to Alfacell all documentation containing Confidential Information of Alfacell that was received by Par pursuant to this Section 4.3, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokines4.5(a).

Appears in 1 contract

Samples: License Agreement (Alfacell Corp)

Right of First Negotiation. (a) If during at any time prior to expiration of the Inhaled Option Period and/or Vaccines Option PeriodAssigned Patents Merck chooses to sell or license the rights to promote, Liquidia desires market and sell the Product (i) in any countries or group of countries outside the Territory except to grant a non-exclusive license to its interest the extent Canada is included among such countries (in which case Section 11.2 shall apply) or (ii) in any one specific country outside the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described Territory unless that country is Canada (in which case Section 11.4(b)(iii11.2 shall apply), then it shall Guilford will have a right of first notify GSK and GSK Bio negotiation with respect to the purchase or license of all but not less than all of such desire in writing, describing in reasonable detail the scope rights from Merck. Such right of the license it is interested in granting first negotiation shall be exercised as follows: Merck will provide Guilford with written notice of such negotiation opportunity prior to initiating discussions with any third party. Such notice shall include a Third Party from whom Liquidia has received a term data sheet or letter of intent (the “ROFN Notice”"Data Sheet") setting forth the proposed territory, the proposed indication, applicable patent rights and GSK and/or GSK Bio thereafter expiration dates, sales in such proposed territory for the last five (5) years by month and year and sales/promotional support information. From the date of delivery of such written notice and Data Sheet and for a period of up to sixty (60) days thereafter, Guilford shall have the exclusive right of first negotiation to obtain an exclusive, worldwide, sublicensable license to Liquidia’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful enter into negotiations with Merck for the making, having made, use, sale, offering for such sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio shall have thirty (30) days from the receipt of the ROFN Notice to inform Liquidia in writing of its election to negotiate the terms of such exclusive license, license and another thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice during the first thirty (30) day period and submits the initial proposal within the second thirty (30) day period, Liquidia Merck shall negotiate exclusively in good faith with GSK or GSK BioGuilford during such period, for a period not subject to exceed six the following. If Guilford desires to engage in discussions with respect to such Data Sheet, it shall notify Merck of such desire within ten (610) months from GSK’s or GSK Bio’s business days of receipt of the ROFN Notice Data Sheet and Merck and Guilford shall cause a meeting of their respective management representatives within ten (the “Negotiation Period”)10) business days of Guilford providing such notice. Within ten (10) business days after such meeting, the terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by the end of the Negotiation Period, then Liquidia Guilford shall be free to negotiate with any Third Party for a non-exclusive license within the same applicable field that was the subject of negotiations with GSK or GSK Bio, and to grant such non-exclusive license to any Third Party; provided, that if Liquidia grants such non-exclusive license to a Third Party within nine (9) months after the expiration of Negotiation Period, then the terms of such Third Party license shall be no less favorable to Liquidia than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia notify Merck whether it desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How continue such discussions and, if not, whether Guilford in a different field than previously proposed to GSK good faith would be interested in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to future discussions regarding *The asterisk denotes that confidential portions of this agreement as indicated by “[***]” and such confidential portions exhibit have been deleted and filed separately with the Securities and Exchange Commission pursuant to omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential portions have been submitted separately to the Securities and Exchange Commission. any one or a subset of the countries in the proposed territory. If Guilford notifies Merck that it desires to continue discussions regarding the Data Sheet, as amendedMerck and Guilford shall negotiate in good faith the terms and conditions of such sale or license for the remaining portion of such sixty (60) day period. basisIf after engaging in such discussions for the remainder of such period the parties are unable to reach a mutually acceptable agreement, Merck shall have the right to freely negotiate with third parties for the sale or vaccine license of the rights to promote, market and sell the Product (i) in all countries or biological products any group of countries outside the Territory (including biosimilar products). For purposes other than Canada) that were included in the Data Sheet or (ii) in any one specific country outside the Territory (other than Canada) that was included in the Data Sheet; provided, however, that if Merck elects to proceed with the sale or license of such rights in some, but not all, of the countries in the proposed territory contemplated by the Data Sheet, it may do so but Guilford shall retain the right of first negotiation contemplated by this Section 4.3, “biological products” means 11.1(a) to the extent of any products that cause a biological effect country with respect to which (i) Guilford indicated it was interested in humans, including, for example, vaccines, monoclonal antibodies future discussions and cytokines(ii) Merck has not sold or licensed the rights in the Product in accordance with this Section 11.1(a) in such country(ies).

Appears in 1 contract

Samples: Transfer and License Agreement (Guilford Pharmaceuticals Inc)

Right of First Negotiation. If during Licensor shall not enter into an agreement with any Third Party to license the Inhaled Option Period and/or Vaccines Option Period, Liquidia desires Licensed IP with regard to grant a non-exclusive license to its interest the Development and Commercialization of Licensed Products in the Joint Inhaled Collaboration Know-How Territory for any Indication or Joint Vaccines Collaboration Know-How as described formulation not included in Section 11.4(b)(iii)the Field, then it shall unless Licensor has first notify GSK delivered to Avenue written notice offering Avenue to negotiate with Licensor the terms and GSK Bio conditions of an amendment to this Agreement to include such desire in writing, describing in reasonable detail the scope new Indication or formulation outside of the license Field, which notice shall identify the specific Indication or formulation for which it is interested in granting would like to enter into such negotiation (Avenue’s such right to negotiate herein referred to as “Right of First Negotiation;” such notice, a Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice;” such new indication or formulation, the “Identified New License) and GSK and/or GSK Bio thereafter shall have the exclusive right of first negotiation to obtain an exclusive, worldwide, sublicensable license to Liquidia’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field)). GSK or GSK Bio Avenue shall have respond to Licensor within thirty (30) calendar days from the following its receipt of the ROFN Notice to inform Liquidia indicate its interest in writing exercising its Right of First Negotiation (an “Exercise Notice”). If Avenue causes Licensor to receive such an Exercise Notice exercising its election to negotiate the terms Right of First Negotiation within such exclusive license, and another thirty (30) calendar day period, then, for a period of up to ninety (90) calendar days to submit to Liquidia an initial proposal for the terms following Licensor’s receipt of such exclusive licenseExercise Notice, the Parties shall use Commercially Reasonable Efforts to negotiate in good faith a reasonable agreement granting Avenue rights to Develop and Commercialize Licensed Products in the Identified New License on terms mutually acceptable to both Parties. If GSK or GSK Bio delivers such notice during In the first event that: (a) Avenue does not provide an Exercise Notice within thirty (30) day period and submits calendar days of receipt of the initial proposal ROFN Notice; or (b) Avenue provides an Exercise Notice to Licensor within the second such thirty (30) calendar day period, Liquidia but the Parties do not execute a definitive agreement granting Avenue rights to Develop and Commercialize Licensed Products in the Identified New License within the ninety (90) day negotiation period mentioned above, Avenue shall negotiate exclusively in good faith with GSK or GSK Bionot have any further rights, for a period and Licensor shall not to exceed six (6) months from GSK’s or GSK Bio’s receipt of the ROFN Notice (the “Negotiation Period”)have any further obligations, the terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio this Section 2.5 and Liquidia fail to reach a binding written agreement for the exclusive license by the end of the Negotiation Period, then Liquidia Licensor shall be free to negotiate enter into negotiations and/or execute a definitive agreement with any Third Party for a non-exclusive license within the same applicable field that was the subject of negotiations with GSK or GSK Bio, and to grant such non-exclusive license to any Third Party; provided, that if Liquidia grants such non-exclusive license to a Third Party within nine (9) months after the expiration of Negotiation Period, then the terms of granting such Third Party license shall be no less favorable the right to Liquidia than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, Develop and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK Commercialize Licensed Products in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokinesIdentified New License.

Appears in 1 contract

Samples: License Agreement (Avenue Therapeutics, Inc.)

Right of First Negotiation. If If, during the Inhaled Option Period and/or Vaccines Option Periodterm of this Agreement, Liquidia (i) Neurogenetics desires to grant a non-exclusive license sublicense to any Person (other than any Affiliate of Neurogenetics) its interest commercialization rights under this Agreement in the Joint Inhaled Collaboration Know-How United States or Joint Vaccines Collaboration Know-How sublicense or otherwise transfer (except as described permitted under Section 11.10) all of its rights under this Agreement (including the Neurogenetics Technology) worldwide, or (ii) a Third Person initiates such discussions with Neurogenetics and Neurogenetics is interested in Section 11.4(b)(iiientertaining such discussions (both (i) and (ii) are collectively referred to as a “Business Opportunity”), then it shall first Neurogenetics will promptly notify GSK and GSK Bio Lilly in writing thereof, with such notice containing all reasonable available information necessary for a potential licensee or commercialization partner to evaluate the Business Opportunity, including proposed terms of such desire transaction; provided that in writing, describing in reasonable detail no event will Neurogenetics be required to disclose to Lilly the scope identity or confidential information of any Third Person. Within [***] days of Lilly’s receipt of the license it is interested written notice, Lilly will respond to Neurogenetics in granting to a Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice”) and GSK and/or GSK Bio thereafter shall have the exclusive right of first negotiation to obtain an exclusive, worldwide, sublicensable license to Liquidiawriting regarding Lilly’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-HowBusiness Opportunity. If Lilly indicates interest in pursuing the Business Opportunity, as applicable, and any other intellectual property rights the Parties will negotiate in good faith to enter into a definitive agreement. If (which may include Liquidia Technologyi) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products Lilly indicates no interest in the applicable field (i.e. a field outside vaccines applications and/or Business Opportunity or does not respond to Neurogenetics with respect to the Inhaled Field). GSK or GSK Bio shall have thirty (30) days from the receipt of the ROFN Notice to inform Liquidia in writing of its election to negotiate the terms of such exclusive license, and another thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice during the first thirty (30) day period and submits the initial proposal applicable Business Opportunity within the second thirty (30) applicable [***] day period, Liquidia shall negotiate exclusively in or (ii) Lilly and Neurogenetics are unable, other than through lack of good faith with GSK or GSK Bioon the part of Neurogenetics, for to enter into a period not to exceed six (6) months from GSK’s or GSK Biodefinitive agreement within [***] days after Lilly’s receipt of the ROFN Notice (the “Negotiation Period”)Neurogenetics’ initial notice or such additional time as is reasonably necessary to obtain any required governmental consents or approval to enter into such agreement, the terms under which Liquidia Neurogenetics will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by the end of the Negotiation Period, then Liquidia shall be free to negotiate enter into such Business Opportunity with any Third Party for a non-exclusive license within the same applicable field that was the subject of negotiations with GSK or GSK Bio, and to grant such non-exclusive license to any Third Party; provided, that if Liquidia grants such non-exclusive license to a Third Party within nine (9) months after the expiration of Negotiation Period, then the another Person on terms of such Third Party license shall be no less favorable to Liquidia Neurogenetics than the terms those last proposed by GSK or GSK Bio to LiquidiaLilly. Notwithstanding anything in this Agreement to the contrary, the licenses that Liquidia may grant to any Business Opportunity entered into by Neurogenetics with a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall Person will be thereafter excluded from and not subject to Lilly’s rights under this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products that cause a biological effect in humansAgreement, including, for examplewithout limitation, vaccines, monoclonal antibodies Lilly’s right to receive the milestone payments and cytokinesroyalty payments.

Appears in 1 contract

Samples: Development and License Agreement (TorreyPines Therapeutics, Inc.)

Right of First Negotiation. If during For a period of [***] from the Inhaled Option Period and/or Vaccines Option PeriodEffective Date, Liquidia desires to grant if Anacor completes a non-exclusive license to its interest Phase II Study on a product that contains a compound having the same mechanism of action as the Licensed Compound (other than the Licensed Product) claimed by Anacor Background Patents in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iiiLead Indication ("Competing Product"), then it Anacor shall first notify GSK and GSK Bio of such desire in writing, describing in reasonable detail the scope of the license it is interested in granting grant to Licensee a Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice”) and GSK and/or GSK Bio thereafter shall have the exclusive right of first negotiation to obtain an exclusiveDevelop, worldwide, sublicensable license Manufacture and Commercialize such Competing Product at such time as the Phase II Data Set (as defined below) is completed. Anacor shall provide the Phase II Data Set to Liquidia’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, Licensee for its review and any other intellectual property rights consideration. Licensee shall provide written notice to Anacor within sixty (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio shall have thirty (3060) days from the of receipt of the ROFN Notice to inform Liquidia in writing Phase II Data Set of its election decision either to enter into negotiations with Anacor for such Competing Product or to forego such negotiations. If Licensee elects to enter into such negotiations, then the Parties will negotiate regarding such license for a period of up to ninety (90) days, such period of time may be extended if agreed by the terms Parties. Following the earlier of the expiration of such exclusive license, and another thirty ninety (30) days to submit to Liquidia an initial proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice during the first thirty (3090) day period and submits (or any agreed upon extended period) or the initial proposal within the second thirty (30) day perioddate Licensee notifies Anacor that it does not wish to proceed with such negotiations, Liquidia shall negotiate exclusively in good faith with GSK or GSK Bio, for a period not to exceed six (6) months from GSK’s or GSK Bio’s receipt of the ROFN Notice (the “Negotiation Period”), the terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by the end of the Negotiation Period, then Liquidia Anacor shall be free to negotiate with any Third Party for a non-exclusive license within the same applicable field that was the subject of negotiations with GSK or GSK Bio, Parties and shall have no further obligations to grant such non-exclusive license to any Third Party; provided, that if Liquidia grants such non-exclusive license to a Third Party within nine (9) months after the expiration of Negotiation Period, then the terms of such Third Party license shall be no less favorable to Liquidia than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to Licensee under this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested 2.8 with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products)that Competing Product. For purposes of this Section 4.32.8, “biological products” "Phase II Data Set" means any products that cause a biological effect in humanspackage of preclinical and clinical data related to the Competing Product generated by or on behalf of Anacor, includingincluding without limitation, for exampleas available, vaccinesthe data and results of all phase I clinical studies, monoclonal antibodies Phase II Studies, and cytokinesall available toxicology and pharmacokinetic data. [***] THE SYMBOL [***] IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION.

Appears in 1 contract

Samples: And Commercialization Agreement (Anacor Pharmaceuticals Inc)

Right of First Negotiation. If during CSL shall have a right of first refusal to the Inhaled Option Period and/or Vaccines Option Period, Liquidia desires grant of any rights in the Field after the Effective Date to BioCryst Intellectual Property Rights in territories outside the Territory (each such proposed grant being a “New Opportunity”). When BioCryst is ready to grant rights to a non-exclusive license New Opportunity, BioCryst shall submit to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iii), then it shall first notify GSK and GSK Bio CSL a reasonably detailed description of such desire New Opportunity, together with a financial proposal for the grant of rights to the New Opportunity. BioCryst shall promptly respond to all reasonable requests of CSL for additional information required in writing, describing in reasonable detail the scope connection with CSL's exercise of the license it is interested in granting to a Third Party right granted under this Section 2.8. CSL will have *** Business Days starting from whom Liquidia has received a term sheet or letter the date of intent receipt of BioCryst’s proposal (the “ROFN NoticeEvaluation Period”) to evaluate such proposal and GSK and/or GSK Bio thereafter to submit a counterproposal to BioCryst. In the event that CSL shall have submit a written counterproposal to BioCryst prior to the exclusive right expiration of first negotiation to obtain an exclusivethe Evaluation Period, worldwide, sublicensable license to Liquidia’s interest in then during the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio shall have thirty (30) days *** Business Days period from the receipt date of the ROFN Notice submission of CSL’s counterproposal to inform Liquidia in writing of its election to negotiate the terms of such exclusive license, and another thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice during the first thirty (30) day period and submits the initial proposal within the second thirty (30) day period, Liquidia shall negotiate exclusively in good faith with GSK or GSK Bio, for a period not to exceed six (6) months from GSK’s or GSK Bio’s receipt of the ROFN Notice BioCryst (the “Negotiation Period”), the Parties shall discuss in good faith the acceptable market terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license grant of rights to CSL in respect of the New Opportunity. During the Evaluation Period and the Negotiation Period (up to *** Business Days in the aggregate, which may be extended by mutual agreement) BioCryst shall not directly or indirectly propose, grant or negotiate with any third party any rights relating to the end relevant New Opportunity. To the extent that BioCryst and CSL shall not reach an agreement regarding the New Opportunity prior to the expiration of the Negotiation Period, then Liquidia BioCryst shall be free to negotiate and effect any transaction with any Third Party for a non-exclusive license within third party regarding the same applicable field that was the subject of negotiations with GSK or GSK Bio, and to grant such non-exclusive license to any Third Party; provided, that if Liquidia grants such non-exclusive license to a Third Party within nine (9) months after the expiration of Negotiation Period, then the terms of such Third Party license shall be no less favorable to Liquidia than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokinesrelevant New Opportunity.

Appears in 1 contract

Samples: License Agreement (Biocryst Pharmaceuticals Inc)

Right of First Negotiation. If during During the Inhaled Option Period and/or Vaccines Option PeriodTerm, Liquidia desires Idera hereby grants to grant Vivelix a non-exclusive license to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iii), then it shall first notify GSK and GSK Bio of such desire in writing, describing in reasonable detail the scope of the license it is interested in granting to a Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice”) and GSK and/or GSK Bio thereafter shall have the exclusive right of first negotiation to obtain an exclusive, worldwidesublicensable license, sublicensable license to Liquidia’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-HowDevelop, as applicablemake, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having have made, use, register, sell, have sold, offer for sale, offering for sale Commercialize, import and export any compound (other than Compounds) Controlled by Idera during the Term that has activity (as evidenced in preclinical models or importation of products in clinical development) in the applicable field (i.e. of inflammatory bowel disease and any and all intellectual property rights Controlled by Idera at any time covering the foregoing, and for which Idera has undertaken an active program to seek a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio partner for such field; provided, however, that Vivelix shall have thirty no such right with respect to any compound that has activity in the field of inflammatory bowel disease but for which Idera believes, in its good faith judgment based on data, inflammatory bowel disease will not be a lead indication. Idera will notify Vivelix in writing when any such compound is available for license and send to Vivelix all Data Controlled by Idera regarding such compound, which will be Confidential Information of Idera and subject to the confidentiality obligations set forth in Article 5. If Vivelix provides to Idera, within forty-five (3045) days from the after receipt of such data, a notice that includes the terms on which Vivelix would like to obtain such license under such intellectual property rights to such compound in the field of inflammatory bowel disease or the GI Field or, if agreed to by Idera any broader field, as determined by Vivelix in such notice (the “Chosen Disease Field”), Idera will negotiate in good faith exclusively with Vivelix for a period of ninety (90) days thereafter (or longer if such period is extended upon mutual agreement of the Parties) (the “ROFN Notice to inform Liquidia in writing of its election to negotiate End Date”) the terms of a definitive license agreement with respect to such exclusive license, and another thirty (30) days to submit to Liquidia an initial proposal for compound in the Chosen Disease Field. If the Parties do not agree on the terms of a definitive license agreement with respect to such exclusive license. If GSK or GSK Bio delivers compound during such notice during the first thirty (30) day period and submits the initial proposal within the second thirty (30) day time period, Liquidia shall negotiate exclusively in good faith with GSK or GSK Bio, for a period not Idera will be permitted to exceed six (6) months from GSK’s or GSK Bio’s receipt of the ROFN Notice (the “Negotiation Period”), the terms under which Liquidia will grant license such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by the end of the Negotiation Period, then Liquidia shall be free to negotiate with any Third Party for a non-exclusive license within the same applicable field that was the subject of negotiations with GSK or GSK Bio, and to grant such non-exclusive license to any Third Party; provided, that if Liquidia grants such non-exclusive license compounds to a Third Party within nine licensee, provided that prior to the date that is one (91) months year after the expiration of Negotiation PeriodROFN End Date, then Idera will not be permitted to grant a license to such compound in the terms of such Chosen Disease Field to a Third Party license shall be no on terms that are less favorable to Liquidia Idera when taken as a whole than the terms last proposed offered by GSK or GSK Bio Vivelix. For purposes of the immediately preceding sentence, if Idera has chosen to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party a license to such compound in a particular proposed one or more fields that together are more broad than the Chosen Disease Field, such broader field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and considered an element of such license that is more favorable to Idera. If Idera does not subject to this Section 4.3 as to the particular field proposed to GSK. Furtherexecute an agreement with a Third Party licensee during such one (1)-year period, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the Vivelix’s right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject above will again apply with respect to Section 4.4 belowsuch compound if since the date on which Idera last sent to Vivelix all Data Controlled by Idera regarding such compound, Liquidia shall be free Idera has generated or obtained additional, material data with regard to grant non-exclusive licenses to such compound and its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply use in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokinesinflammatory bowel disease.

Appears in 1 contract

Samples: License Agreement (Idera Pharmaceuticals, Inc.)

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