BioSci – Opt-in and Opt-out Provisions
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Opt In/Out TagOpt-In or -OutOption HolderOption DurationImplications for Financial ConsiderationDeal DateR&DClientLicensee CategoryStage at SigningDeal Source
Upfront Cash ($M)
Deal Size ($M)
Maximum Share (%)
DealTerritoryDeal SubjectDeal TypeDiseaseIndicationTechnologySub-Technology
Upfront Equity ($M)
Contingent Equity ($M)
R&D Support ($M)
FTE Rate ($M)Loan ($M)
Dev / Reg Milestones ($M)
Other Milestones ($M)
Total Precommercial Payments ($M)
Sales Milestones ($M)
EFR$200M (%)EFR$500M (%)EFR$1B (%)
Marketing Fee (%)
Transfer Price (%)
Manufacture Cost + (%)
Profit Split (%)Financial Term Explanations
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TagOutEither partyPhase III done10-20% royalty, depending on stage & party8/2009Emergent BioSolutions, TrubionAbbott, FacetTop PharmaPhase IFOIA 20.00 206.50 50.00 DealWorldwide
TRU-016 (CD37 modulator) for for chronic lymphocytic leukemia (CLL)
Co-Development, Co-Promotion, Equity, License, Termination
CancerLeukemiaRecombinant DNA 10.00 0.28 128.50 48.00 206.50 50.00
10-20% royalty if Trubion opts out of co-dev, depending on stage at opt-out
3
TagOutEither partyAny20-25% royalty if Ariad; 40% PS if Merck7/2007Takeda, ARIAD PharmaceuticalsMerckTop PharmaPhase IIFOIA 75.00 927.00 50.00 DealWorldwide
Taltorvic (ridaforolimus mTOR inhibitor) for sarcoma & solid tumors
Co-Development, Co-Promotion, License, Loan, Supply, Termination
CancerBroad Focus Cancer, Solid TumorsSyntheticsSmall Molecule 0.28 200.00 88.50 363.50 727.00 200.00 15.00 15.00 16.00 50.00
$200M loan for Ariad share of dev costs above $150M | $88.5M sarcoma | 5050 US PS for sacroma & other indications until opt-out
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TagOutEither partyAny10-15% royalty, depending on party & stage7/2007Roche, GenentechIpsen, TercicaMid Tier PharmaPreclinicalFOIA 18.00 12.00 DealWorldwideGrowth hormone & IGF-1 combination product for short stature
Co-Development, Co-Promotion, Equity, License, Option
Endocrinological & MetabolicGrowth Hormone DisordersRecombinant DNA 4.00 9.00 5.00 18.00 12.00 12.00 12.00 25.00 50.00
GNE purchases 708.6K Tercica shares | Add'l $4M eq purchase if GNE extends opt-in period, plus $5M eq at approval | 12% royalty to GNE if GNE never opts-in | 50/50 PS for Short Stature and AGHD Indications after GNE opt-in, but drops to 33.3% if GNE pays $10M to have tie-breaking vote
5
TagOutEither partyAny3-14% royalty, depending on stage8/2006Infinity PharmaceuticalsAstraZeneca, MedImmuneTop PharmaPhase I, DiscoveryFOIA 70.00 500.00 50.00 DealWorldwide
IPI-504 (hsp90 inhibitor) and Hedgehog cell-signaling pathway for cancer
Co-Development, Co-Promotion, License, Termination
CancerBroad Focus CancerSyntheticsSmall Molecule 140.00 140.00 350.00 150.00 50.00
$75M for each of Hedgehog & Hsp90 Products | $140M for Hedgehog Products | $140M for Hsp90 Products
6
TagOutEither partyAny5-12% royalty, depending on stage7/2006AlnylamMerckTop PharmaDiscoveryFOIA 84.50 50.00 DealWorldwideRNAi for nine non-druggable targets
Co-Development, Co-Promotion, License, Option, Research, Restatement, Termination
UnlimitedOligonucleotidesRNAi 0.49 41.00 43.50 84.50 10.00 11.40 13.00 50.00
10-15% ROW royalty for RNAi Products; 5-10% on Merck Development Products | $30.5M for Opt-out RNAi Product; $5.5M for Profit Sharing RNAi Product; $7.5M on Merck's Opt-in for RHOA Product | 50/50 PS on Profit Sharing RNAi Products in US | $41M for Merck Development Products
7
TagOutEither partyAny1.5-6% royalties & milestones depending on stage7/2006ChemDivClinical Data, Avalon PharmaceuticalsOther BiotechDiscoveryFOIA 0.20 50.00 DealWorldwideScreening of combichem library against drug targetsCo-Development, License, ResearchUnlimitedScreening, SyntheticsCombinatorial 0.20 0.20 50.00
8
TagOutEither partyAnyreduced royalty & milestones TBD1/2006
Nycomed Pharma, Takeda, Bradley Pharmaceuticals
MedigeneOther BiotechFiledFOIA 5.00 69.50 10.00 DealNAFTAPolyphenon ointment for genital warts in USCo-Development, LicenseDermatologic, Infectious-ViralActinic Keratosis, Other Infectious-ViralNatural Product 14.00 20.50 39.50 30.00 10.00 10.00 10.00
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TagOutEither partyAnyIndependent 2-22% royalty, depending on stage9/2005Facet, Abbott, AbbVie, PDL BioPharmaBiogenMajor BiotechPhase II, Orphan IndicationFOIA 40.00 520.00 50.00 DealWorldwide
Zinbryta (daclizumab) for multiple sclerosis, M200 (volociximab) & HuZAF (fontolizumab)
Co-Development, Co-Promotion, Equity, License, Supply
Autoimmune/Inflammatory, Cancer, Central Nervous System
Broad Focus Autoimmune/Inflammatory, Multiple Sclerosis, Solid Tumors
MonoclonalsHumanized Abs 5.00 0.25 85.00 240.00 370.00 50.00 12.00 13.60 16.80 15.00 50.00
$85M in dev/reg milestones for IL-2R or INFy for 1st indication | $80M for each of 2nd & 3rd IL-2R or INFy indications, plus $40M for each of 2nd &3rd A5B1 indications | 50/50 PS in NA and EU | ROW Royalty of 12-20%
10
TagOutEither partyAny3-12% royalty, depending on stage5/2005Lexicon PharmaceuticalsSchering-Plough, Merck, OrganonTop PharmaDiscoveryFOIA 22.50 82.50 50.00 DealWorldwide
Drug targets from genes that encode secreted proteins & antibody targets
Co-Development, License, Research, Termination
UnlimitedGenomics, TransgenicsGene Expression 50.00 0.30 10.00 82.50 50.00
3-12% royalty on Opt-out Products, depending on stage of dev at opt-out
11
TagOutEither partyAny1.5-9.5% royalty, depending on stage/party5/2005XomaNovartis, ChironTop PharmaDiscoveryFOIA 10.00 60.00 30.00 DealWorldwideCD40, M-CSF, MN & EphB3 Mabs for cancer
Co-Development, Co-Promotion, License, Loan, Option, Research, Restatement, Termination
CancerBroad Focus CancerMonoclonalsHuman Abs 0.28 50.00 60.00 30.00
Xoma funds 30% Chiron 70% | $50M loan facility (see separate contract) | 22.5-30% PS to Xoma, with lower rate paid until $15M differential utilized (or reduced via milestones accomplished)
12
TagOutEither partyAny1.75-9% royalty, depending on stage2/2005Mirati Therapeutics, MethylGeneEnVivo PharmaceuticalsOther BiotechDiscoveryFOIA 0.50 1.70 50.00 DealWorldwide
HDAC (histone deacetylase) inhibitors for Huntington's & neuro diseases
Co-Development, Co-Promotion, License, Research, Termination, Warrant
Central Nervous System
Alzheimer's Disease, Other Central Nervous System, Parkinson's Disease
Genomics, Screening, SyntheticsGene Expression, Small Molecule 1.20 0.15 1.70 50.00
52.5K warrant shares of MethylGene common | $600K for 4 MethylGene FTEs @ $150K/FTE, plus first $600K for Alzheimer's program (all other costs shared 50/50)
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TagOutEither partyAnyroyalty-free (but sublicense rev sharing)11/2004Cambridge Antibody TechnologyAstraZenecaTop PharmaDiscoveryFOIA 305.00 21.00 DealWorldwideHuman antibodies for inflammation
Co-Development, Co-Promotion, Equity, License, Research
Autoimmune/InflammatoryBroad Focus Autoimmune/InflammatoryMonoclonalsHuman Abs 105.00 0.22 100.00 205.00 100.00 19.00 19.00 19.00 75M pounds sterling
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TagOutEither partyPhase II data0-8% royalty, depending on stage7/2004Seattle GeneticsApplera, Quest Diagnostics, CeleraMid Tier PharmaDiscoveryFOIA 18.00 50.00 DealWorldwideADC technology for novel cell surface proteins to treat cancer
Co-Development, Co-Promotion, License, Option, Research
CancerBroad Focus CancerMonoclonalsConjugates 0.28 3.00 3.00 15.00 50.00
0-8% royalty by Continuing party after opt-out, depending on stage of dev at opt-out
15
TagOutEither partyPhase IIb data$25M milestones & 10-15% royalty6/2004AlnylamMerckTop PharmaDiscoveryFOIA 3.00 33.50 50.00 DealWorldwideRNAi VEGF for ocular diseases
Co-Development, Co-Promotion, License, Research, Termination
OphthalmicBroad Focus OphthalmicOligonucleotidesRNAi 0.49 30.50 33.50 10.40 11.40 13.00 50.00
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TagOutEither partyAny3-25% royalty, depending on stage of dev12/2003Lilly, UroGene, SGX PharmaceuticalsPierre FabreMid Tier PharmaDiscoveryFOIA 25.00 DealEuropeInhibitors of RON tyrosine kinase for bladder cancer in Europe
Co-Development, License, Research, Termination
CancerBladderGenomics, SyntheticsPharmacogenomics, Small Molecule 0.20 25.00 25.00 25.00 50/50 cost sharing
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TagOutEither partyAnyroyalty-free license vs 50% PS12/2003ViaCellAmgenMajor BiotechPreclinicalFOIA 30.00 50.00 DealWorldwideStem cell based cell therapy
Co-Development, Equity, License, Option, Warrant
UnlimitedCell Therapy - Stem Cells/Factors 20.00 10.00 50.00 50/50 PS on Collaboration Products
18
TagOutEither partyAny$8.5M milestones plus 2-6% royalty10/2003Bristol-Myers Squibb, MedarexClinical Data, Avalon PharmaceuticalsOther BiotechDiscoveryFOIA 50.00 DealWorldwideHuman antibodies to selected cancer targetsCo-Development, License, ResearchCancerBroad Focus CancerMonoclonalsHuman Abs 50.00 2-6% royalty if one party opts-out, depending on stage at opt-out
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TagOutEither partyAny2% lower royalty & no co-promotion8/2002Rigel PharmaceuticalsDaiichi SankyoJapanese PharmaDiscoveryFOIA 1.00 29.04 6.00 DealWorldwideProtein degradation of MDM2 ubiquitin ligase for cancer therapy
Co-Development, Co-Promotion, License, Option, Research
CancerBroad Focus CancerScreening, SyntheticsSmall Molecule 5.04 0.28 20.00 3.00 29.04 4.00 4.00 4.00
6 FTEs/yr for 3 yrs @ $275K, $280K & $285K/FTE/yr | 4% royalty, but 6% if Rigel co-dev | Add'l $3M if Rigel co-dev
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TagOutEither partyAny3% add'l royalty until 65% cost recovered6/2002Applera, Quest Diagnostics, CeleraAbbottTop PharmaDiagnosticFOIA 50.00 DealWorldwideIn vitro diagnostic products and services
Co-Development, Co-Promotion, License, Research, Termination
CancerDiagnosticsDNA Probes 50.00
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TagOutEither partyAny0.5-4% royalty, depending on IP1/2002Seattle GeneticsDanisco, GenencorOther BiotechLead Molecule, DiscoveryFOIA 1.00 5.50 50.00 DealWorldwideADEPT technology for cancer prodrugsCo-Development, Equity, License, ResearchCancerBroad Focus Cancer, MelanomaMonoclonals 3.00 0.20 1.50 6.00 50.00 3-4% royalty if SGEN opts-out of co-dev
22
TagOutEither partyAny1-2% royalty, depending on party11/2001Ionis Pharmaceuticals
Achieve Life Science, OncoGenex Pharmaceuticals
Other BiotechPreclinicalFOIA 0.50 0.50 65.00 DealWorldwideOGX-011 (antisense inhib of clusterin) for prostate cancerCo-Development, License, TerminationCancerProstateOligonucleotidesAntisense/Triple helix 0.33 0.50 65.00
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TagOutEither partyAnyby stage: 2.5-25% PS plus 1-5% royalty10/2001Athersys
Johnson & Johnson, 3-Dimensional Pharmaceuticals
Top PharmaDiscoveryFOIA 50.00 DealWorldwide
Small molecules to GPCR targets (VR1, MCHR1, CXCR3, Glucagon rec)
Co-Development, License, ResearchUnlimitedGenomics, ScreeningGene Expression, Proteomics 0.25 50.00
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TagOutEither partyPhase IIb dataIf appvd: 300% of share plus 4% lower PS7/2001Lilly, ICOSBiogenMajor BiotechPhase IFOIA 8.00 111.50 50.00 DealWorldwide
Oral LFA-1 (Leukocyte Function Antigen-1) antagonists for inflammation
Co-Development, Co-Promotion, License, Loan, Supply, Termination
Autoimmune/InflammatoryBroad Focus Autoimmune/InflammatorySyntheticsSmall Molecule 20.00 30.00 21.00 79.00 32.50 50.00 50.00 $20M forgivable loan, based on clinical milestones
25
TagOutEither partyAny$8.5M milestones plus 3-5% royalty6/2001Amgen, deCODE GeneticsMedarex, Bristol-Myers Squibb, GenmabTop PharmaDiscoveryFOIA 17.00 50.00 DealWorldwideFully human antibodies from genomic dataCo-Development, License, ResearchUnlimitedGenomics, MonoclonalsHuman Abs, Pharmacogenomics 8.50 8.50 15.00 3.50 4.40 4.70 50.00
Licensee pays 3-5% royalty on unilateral products | Licensee pays $8.5M in dev/reg milestones for each add'l unilateral product | Licensee pays $8.5M in dev/reg milestones for 1st unilateral product
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TagOutEither partyPhase III done$8.5M milestones plus 3-5% royalty2/2001Medarex, Bristol-Myers Squibb, GenPharmSeattle GeneticsOther BiotechDiscoveryFOIA 22.50 50.00 DealWorldwide
Human MAb to p97 (melanotransferrin) for treatment of melanoma
Co-Development, License, ResearchCancerMelanomaMonoclonalsHuman Abs 8.50 14.00 22.50 3.50 4.40 4.70 50.00
5% max royalty on Unilateral Products | $8.5M for first Unilateral Product | $14M for add'l Unilateral Products
27
TagOutEither partyAny5% royalty on Independent Product12/1999Novartis, ChironPathoGenesisOther BiotechDiscoveryFOIA 50.00 DealWorldwideCombinatorial chemistry to discover novel anti-bacterialsCo-Development, License, ResearchInfectious-BacterialBroad Focus Infectious-BacterialScreening, SyntheticsCombinatorial, Small Molecule
28
TagOutLicenseePhase I data5% royalty until dev cost recovered, then 1%11/2008Infinity PharmaceuticalsPurdue PharmaMid Tier PharmaDiscoveryFOIA 13.50 20.00 DealNAFTAFAAH (Fatty Acid Amide Hydrolase) for solid tumors in USLicense, Research, TerminationCancerSolid TumorsSyntheticsSmall Molecule 13.50 0.38 13.50 12.50 17.00 18.50 $13.5M over 3 yrs @ $375K/FTE
29
TagOutLicenseeAnyroyalty-free and supply at cost +10%8/2004Palatin TechnologiesPfizer, King PharmaceuticalsTop PharmaPhase IIFOIA 15.00 250.00 50.00 DealWorldwide
PT-141 (melanocortin receptor agonist) sexual dysfunction in NAFTA & ROW
Co-Development, Co-Promotion, Equity, License, Warrant
Genitourinary/GynecologicSexual DysfunctionPeptides 5.00 12.50 37.50 50.00 120.00 130.00 50.00
$12.5M warrant | $27.5M cash & $10M eq for ED | $40M cash & $10M eq for other | 40% PS to Palatin in NAFTA to $400M, then 35% PS above; 50/50 in ROW
30
TagOutLicensorPhase I dataReduced PS (50 to 26%) if KHK opt-out of co-dev6/2016Kyowa Hakko KirinAevi Genomic MedicineOther BiotechPhase I, Orphan IndicationFOIA 2.00 20.00 50.00 DealNAFTAAnti-LIGHT (TNFSF14 mAb) for severe pediatric onset IBD in NACo-Development, License, Option, SupplyGastrointestinalIBD - OtherMonoclonalsHuman Abs 0.35 18.00 20.00 10.00 50.00
$2M on license exercise | equal sharing up to $17.5M aggergate, then all by Medgenics in Territory & EU | $150K-$350K/FTE | KHK pays 13% royalty to Medgenics on EU sales | 50/50 PS in NA if KHK co-develops; otherwise 74% PS to Medgenics
31
TagOutLicensorPhase II dataReduced PS (25 to 15% floor) based on reduced cost3/2016Arcturus TherapeuticsProvidence TherapeuticsOther BiotechDiscovery, FormulationSEC Full 0.50 0.50 25.00 DealWorldwide
Individualized LUNAR delivery of mRNA vaccine for brain, breast and ovarian neoplasms
Co-Development, Joint Venture, License, Research
CancerBrain, Breast, OvarianDrug Delivery, VaccinesOther 0.35 0.50 25.00 25% PS to Arcturus (unless opt-out)
32
TagOutLicensorPhase I data2x co-dev cost & 1-5% of Net Income5/2015BerylliumArQuleOther BiotechDiscoveryFOIA 50.00 DealWorldwideScreening small molecules targeting PD-1 and PDL-1
Co-Development, License, Research, Termination
CancerBroad Focus CancerScreening, SyntheticsSmall Molecule 0.33 50.00
33
TagOutLicensorPhase III datareimb of add'l co-dev cost plus 10-13.5% royalty12/2014MacroGenicsJohnson & Johnson, JanssenTop PharmaPreclinicalFOIA 50.00 700.00 30.00 DealWorldwide
Duvortuxizumab (MGD011 humanized CD19 /CD3) for multiple B-cell malignancies
Co-Development, Co-Promotion, Equity, License, Option, Termination
CancerLeukemia, LymphomaMonoclonalsBispecific 75.00 0.28 210.00 215.00 550.00 150.00 10.00 10.00 10.00 30.00
$210M for DLBCL (diffuse large B-cell lymphoma) | $215M for add'l indications | 30% PS in NA if MacroGenics pays 20% of Global Dev Costs
34
TagOutLicensorPhase II data6-12.5% royalty, depending on stage & sales11/2014Proteostasis TherapeuticsAstellas PharmaJapanese PharmaDiscovery, Orphan IndicationFOIA 408.80 12.50 DealWorldwide
Protein folding platform to treat alpha-1 anti-trypsin deficiency via UPR modulation
Co-Development, Co-Promotion, Equity, License, Loan, Option, Research
Other/MiscellaneousGenetic DisordersScreening, SyntheticsSmall Molecule 5.00 5.80 0.33 56.00 66.80 342.00 5.50 6.00 6.75
$5M equity via conversion of 7/14 note | 17.75 FTEs @ $325K/FTE | 5.5-7.5% if no co-dev; 6-12.5% if co-dev, depending on how far into clinical trials
35
TagOutLicensorPhase III done50% US PS, less share of Selling Expenses4/2012Novartis, EndocyteMerckTop PharmaPhase IIIFOIA 120.00 1,001.50 50.00 DealWorldwideVintafolide (EC145) folate conjugate for lung & ovarian cancer
Co-Development, Co-Promotion, License, Option, Termination
CancerLung, OvarianSyntheticsSmall Molecule 0.25 47.50 334.00 501.50 500.00 14.00 14.00 15.00 50.00
Endocyte pays 75% of PROC (ovarian) Ph III plus 100% of Companion Diagnostic; Merck pays all other dev costs | 14-20% ex-US royalty | $47.5M for Ovarian (PROC) | $60M for Lung; $274N for Other Indications | 50% PS in US
36
TagOutLicensorAnyroyalty reduced 4x (1 - actual co-dev/co-dev cap)10/2010Amicus TherapeuticsGlaxoSmithKlineTop PharmaPhase III, Orphan IndicationFOIA 30.00 234.00 19.00 DealWorldwideAmigal (migalastat) for Fabry disease
Co-Development, Equity, License, Supply, Termination
Endocrinological & MetabolicLysosomal Storage DisordersSyntheticsSmall Molecule 31.00 0.30 93.50 154.50 80.00 16.50 18.00 18.50
$31M equity (19.9% OS @ 30% premium to FMV - see separate agmt) | 14-19% royalty, subject to reduction of 4x ratio of actual co-dev cost vs. total co-dev cap, if Amicus opts out of co-dev
37
TagOutLicensorAny14-24% royalty, depending on stage & sales1/2009ZymoGeneticsBristol-Myers SquibbTop PharmaPhase IFOIA 105.00 1,106.50 40.00 DealWorldwidePEG-IFN Lambda for HCV
Co-Development, Co-Promotion, License, Option
Infectious-ViralHepatitis CDrug Delivery, Peptides, Recombinant DNAPEG Products 0.26 430.00 286.50 821.50 285.00 14.00 14.50 16.25 40.00
14-20% royalty in ROW (max 24% in US if Opt-out after unblinding first Ph III) | $430M for HCV | $286.5M for HBV plus non-Hepatitis indications | 40% US PS if co-dev
38
TagOutLicensorFiling8-12% royalty & milestones, based on stage & sales1/2009AlnylamMerck, CubistTop PharmaPhase IIFOIA 20.00 102.50 50.00 Deal
Africa, Europe, Middle East, NAFTA, South America
ALN-RSV01 for respiratory syncytial virus infections ex-Asia
Co-Development, License, Supply, Termination
Infectious-ViralRespiratory Syncytial Virus/RSVOligonucleotidesRNAi 0.36 30.00 22.50 72.50 30.00 10.50 12.20 13.90 50.00 10-16% royalty ex-NAFTA | 50% PS in NAFTA
39
TagOutLicensorFiling16-23% royalty, depending on sales & dev costs12/2008ExelixisBristol-Myers SquibbTop PharmaPhase III, Phase IFOIA 240.00 1,100.00 50.00 DealWorldwide
Cabozantinib (XL184 MET, VEGFR2, RET inhib) & XL281 (RAF kinase inhib) for thyroid & solid tumors
Co-Development, Co-Promotion, Development, License, Termination
CancerOther Cancer, Solid TumorsSyntheticsSmall Molecule 0.26 30.00 530.00 800.00 300.00 14.00 14.00 15.00 50.00
$195M on signing & $45M in 2009 | $150M in sales milestones for each product | $30M for XL184 for thyroid cancer | $315M in dev/reg milestones for XL281; $130M for XL184 in major tumor & $135M in glioblastoma | 50/50 US PS for XL184 if EXEL co-develops | 14-18% ex-US for XL184; 12-16% for XL281
40
TagOutLicensorAny4-14% royalty, depending on stage, product & sales8/2008Facet, Abbott, PDL BioPharmaBristol-Myers SquibbTop PharmaPhase IFOIA 30.00 1,155.00 30.00 DealWorldwide
Elotuzumab (HuLuc63 CS1 Mab) for multiple myeloma & option for PDL-241
Co-Development, License, OptionCancerMultiple MyelomaMonoclonalsHumanized Abs 0.26 260.00 465.00 755.00 400.00 13.00 13.00 13.50 30.00
$200M in sales milestones for each compound | 13-16% ex-US royalty for HuLuc63; 12-14% ex-US royalty for Other Products | $260M for MM | $110M for each of 2nd & 3rd indication for HuLuc63; $15M on PDL-241 option exercise, $110M for PDL-241 1st indication, plus $60M for each of 2nd & 3rd indication | 30% PS to PDL in US
41
TagOutLicensorFilingAll Products: 18-24% royalty, depending on sales10/2007
Madrigal Pharmaceuticals, Synta Pharmaceuticals
GlaxoSmithKlineTop PharmaPhase IIFOIA 80.00 1,010.00 50.00 DealWorldwide
Elesclomol (STA-4783 oxidative stress inducer to trigger apoptosis) for melanoma
Co-Development, Co-Promotion, Equity, License, Termination
CancerMelanomaSyntheticsSmall Molecule 45.00 0.25 135.00 450.00 710.00 300.00 16.00 16.00 17.50 50.00
$45M in aggregate put equity at two milestones for 125% FMV | 16-22% royalty in ROW | 40% PS in US for first $500M, then 50/50 PS thereafter
42
TagOutLicensorPhase IIb dataNew Indications: recoup costs lower PS & milestones10/2007
Madrigal Pharmaceuticals, Synta Pharmaceuticals
GlaxoSmithKlineTop PharmaPhase IIFOIA 80.00 1,010.00 50.00 DealWorldwide
Elesclomol (STA-4783 oxidative stress inducer to trigger apoptosis) for melanoma
Co-Development, Co-Promotion, Equity, License, Termination
CancerMelanomaSyntheticsSmall Molecule 45.00 0.25 135.00 450.00 710.00 300.00 16.00 16.00 17.50 50.00
$45M in aggregate put equity at two milestones for 125% FMV | 16-22% royalty in ROW | 40% PS in US for first $500M, then 50/50 PS thereafter
43
TagOutLicensorFiling30% PS in Shared Territory8/2007Nektar Therapeutics, AerogenBayerTop PharmaPhase II, FormulationFOIA 50.00 175.00 30.00 DealWorldwide
BAY41-6551 (NKTR-061, inhaled amikacin) for gram-negative pneumonias
Co-Development, Co-Promotion, License, Supply, Termination
Infectious-BacterialPneumoniaDrug Delivery, SyntheticsOther, Small Molecule 70.00 120.00 55.00 14.25 22.20 26.10 30.00 48.00
14-30% in ROW; also 30% in US if opt-out of PS | 48% PS to Nektar in US (eliminated per 12/10 am) | Supply by Nektar dropped per 12/10 am
44
TagOutLicensorAny13-29% royalty, depending on stage12/2005MaxygenRocheTop PharmaPreclinicalFOIA 8.00 104.00 37.00 DealWorldwideMAXY_VII (recombinant factor VIIa) for acute bleeding indications
Co-Development, License, Option, Termination
HematologicOther HematologicRecombinant DNA 0.35 52.00 44.00 104.00 27.60 30.00 33.25 27-37% in US; 20-30% in ROW
45
TagOutLicensorAnypre-opt-out co-dev reimb via sales milestones12/2004Amgen, MicrometMerck Serono, SeronoTop PharmaPhase IIFOIA 10.00 148.00 15.00 DealWorldwide
MT201 (adecatumumab) anti EpCAM human monoclonal for cancer
Co-Development, Co-Promotion, License, Option
CancerBreast, ProstateMonoclonalsHuman Abs 0.20 84.00 54.00 148.00 8.00 8.50 9.25 50.00
royalty is in addition to any profit split for co-co dev | 50% PS if co-dev & co-promote in US and/or EU
46
TagOutLicensorPhase IIb data13.25-17% royalties11/2004MedarexBristol-Myers SquibbTop PharmaPhase IIIFOIA 25.00 223.75 45.00 DealWorldwide
Yervoy (ipilimumab MDX-010 huMAb to CTLA-4) & MDX-1379 (gp-100) for melanoma
Co-Development, Co-Promotion, Equity, License, Option
CancerMelanomaMonoclonalsHuman Abs 60.00 58.75 143.75 55.00 10.50 12.60 13.80 45.00 US PS if Co-Promotes | 15% max royalty for ex-US
47
TagOutLicensorAny4-8% royalty in NAFTA vs. 50% PS6/2002Amgen, TularikDaiichi Sankyo, SankyoJapanese PharmaDiscoveryFOIA 2.00 81.25 50.00 DealWorldwideScreening of 5 orphan GPCR drug targets
Co-Development, Co-Promotion, License, Research
UnlimitedScreening, SyntheticsSmall Molecule 14.75 0.28 19.50 36.25 45.00 4.00 5.00 5.50 50.00
4-8% royalty ex-NAFTA | 50% split of Distributable Margin in NAFTA
48
TagOutLicensorFilingsubsequent milestones plus 5-12% royalty2/2002Ligand, PharmacopeiaSchering-Plough, Merck, OrganonTop PharmaDiscoveryFOIA 15.00 95.25 12.00 DealWorldwideDiscovery of drug candidates
Co-Development, Co-Promotion, License, Option, Research
UnlimitedScreening, SyntheticsCombinatorial 5.00 20.00 0.29 29.00 8.75 77.75 17.50 5.50 5.80 6.40 35.00
$15M on restatement date | $5M equity put by Pharmacopeia | $4M/yr for 5 yrs | $162/Manhour x1800 hours | 5-12% if Lead Optimized; otherwise 3-5% | 35% co-co option for 35% PS
49
TagOut/InEither partyAny200% of share of dev costs6/2011Meda ABBausch HealthMid Tier PharmaApprovedFOIA 76.00 DealNAFTA
Elidel (pimecrolimus 1% cream) and Xerese (acyclovir and hydrocortisone cream) for derm in NAFTA
LicenseDermatologicBroad Focus Dermatologic 16.00 92.00
22% royalty for 2011, declining to 18% in 2012 then 10% thereafter
50
TagOut/InEither partyFiling65% of dev costs12/2010XomaServierMid Tier PharmaPhase IIFOIA 15.00 738.00 19.00 Deal
Africa, Asia, Europe, Middle East, NAFTA, South America
Xoma 052 (gevokizumab) anti-IL1 beta mAb for diabetes and cardio ex-US & Japan
Co-Development, License, Loan, Supply, Termination
Autoimmune/Inflammatory, Cancer, Cardiovascular, Endocrinological & Metabolic, Ophthalmic
Broad Focus Cancer, Broad Focus Cardiovascular, Diabetes, Other Autoimmune/Inflammatory, Uveitis
MonoclonalsHumanized Abs 50.00 18.00 68.00 262.00 413.00 325.00 10.00 10.40 11.10 10.00
$325M or $186M (155M Euros) if Xoma keeps diabetes for US/Japan | 10% EFR in US/Japan if Retained Territory released by Xoma | 10.4% EFR in US/Japan if Retained Territory released by Xoma | 11.1% EFR in US/Japan if Retained Territory released by Xoma | 19% max royalty, based on Daily Cost of Treatment and COGS as function of Sales price | 15M Euros | $325M precomm'l payments if Xoma keeps diabetes in US/Japan; otherwise $413M | $20M US plus 40M Euros | $174M plus add'l $88M if Xoma drops co-dev
51
TagOut/InEither partyPhase II data150% of dev costs (internal & out-of-pocket)6/2010Shire, DyaxLeadiant Biosciences, DefianteMid Tier PharmaPhase IIIFOIA 2.50 112.50 41.00 DealAfrica, Europe, Middle East
Kalbitor (DX-88 ecallantide) for hereditary angioedema (HAE) in Europe, Mideast & Africa
Co-Development, Equity, License, Supply, Termination
Autoimmune/InflammatoryOther Autoimmune/InflammatorySyntheticsSmall Molecule 2.50 10.00 15.00 97.50 41.00
52
TagOut/InEither partyPhase III data200% of share of dev cost (250% if first Ph III data)10/2009Bristol-Myers Squibb, AmylinTakedaTop PharmaPhase II, DiscoveryFOIA 75.00 1,320.00 30.00 DealWorldwidePramlintide/metreleptin and davalintide for treatment of obesity
Co-Development, Co-Promotion, License, Supply, Termination
Endocrinological & MetabolicObesityPeptides 0.30 115.00 330.00 520.00 800.00 15.00 15.00 17.50
53
TagOut/InEither partyFiling105-120% cost plus interest, depending on stage8/2008Bausch HealthGlaxoSmithKlineTop PharmaPhase III, Orphan IndicationFOIA 125.00 820.00 50.00 DealWorldwide
Retigabine (KCNQ2/3 receptor potassium channel modulator) for epilepsy
Co-Development, Co-Promotion, LicenseCentral Nervous SystemEpilepsySyntheticsSmall Molecule 135.00 420.00 680.00 140.00 15.00 18.00 19.00 50.00
ROW royalty: 15-20% for Retigabine; 10-20% for Add'l Product | $135M for Epilepsy | $90M for each of 3 Non-Epilepsy Indications, plus $150M for first Additional Product | 50% PS in NA & Oceania for immediate release product; 30-50% for modified release product, depending on year and sales level
54
TagOut/InEither partyPhase II data2x dev cost if Merck opt-in; 100% dev cost if GTx11/2007Oncternal Therapeutics, GTxMerckTop PharmaPhase II, Preclinical, Lead MoleculeFOIA 40.00 592.00 23.00 DealWorldwide
Ostarine (selective androgen receptor modulator) for cancer-related muscle loss
Co-Development, Co-Promotion, Equity, License, Research, Termination
Cancer, Endocrinological & Metabolic
Other Cancer, Other Endocrinological & Metabolic
SyntheticsSmall Molecule 30.00 15.00 60.00 447.00 592.00 13.00 13.00 13.00
1.285M common shares @ $23.34/sh (see Equity agmt) | $5M in R&D funding/yr for 3 yrs | $60M for Ostarine for Cancer Cachexia | $220M for sarcopenia; $142M add'l for cancer cachexia; $85M for any other indication
55
TagOut/InEither partyPhase IIb data100% of development costs11/2007Amicus TherapeuticsTakeda, Shire
Major Biotech, Top Pharma
Phase II, Orphan IndicationFOIA 50.00 440.00 22.00 Deal
Africa, Asia, Europe, Middle East, NAFTA, South America
Plicera for Gaucher, Amigal for Fabry & AT2220 for Pompe genetic disorders ex-US
Co-Development, License, Option, Termination
Endocrinological & Metabolic, Other/Miscellaneous
Genetic Disorders, Lysosomal Storage Disorders
SyntheticsSmall Molecule 60.75 0.25 150.00 260.75 240.00 11.50 12.75 14.88 50/50 sharing of $121.5M budgeted dev costs over 3 yrs
56
TagOut/InEither partyPhase III done100% cost plus 25% compounded annual interest9/2007Shire, NPS PharmaceuticalsTakeda, Nycomed PharmaTop PharmaPhase IIIFOIA 10.00 225.00 18.00 Deal
Africa, Asia, Europe, Middle East, South America
Gattex/Revestive (teduglutide GLP-2) for short bowel syndrome and GI ex-NAFTA
Co-Development, License, TerminationGastrointestinal
Bowel Movement Disorders, Other Gastrointestinal
Peptides 0.28 50.00 145.00 205.00 20.00 18.00 18.00 18.00 $50M for SBS
57
TagOut/InEither partyFiling50% of dev costs plus 100% of share of dev costs6/2007Bristol-Myers Squibb, ZymoGeneticsBayerTop PharmaFiledFOIA 30.00 158.00 20.00 Deal
Africa, Asia, Europe, Middle East, NAFTA, South America
Recothrom (rThrombin) for hemostasis ex-USCo-Development, LicenseHematologicOther HematologicRecombinant DNA 23.00 53.00 105.00 13.50 16.00 18.20 18.00
15-20% sales commission to Bayer on US co-promotion (see separate analysis) | $23M in ex-US milestones, plus add'l $40M on US approval (see separate analysis)
58
TagOut/InEither partyAny100-200% of cost share, depending on stage9/2006Oncternal Therapeutics, GTxIpsenMid Tier PharmaPhase IIIFOIA 30.00 74.20 25.00 DealEurope
Acapodene (toremifene) for treatment of prostate cancer & prevention of fractures in Europe
Co-Development, License, Supply, Termination
Bone Disease, CancerOther Bone Disease, ProstateSyntheticsSmall Molecule 0.23 11.70 32.50 74.20 30.00
23M Euros | royalty rate is 30% minus cost of supply; min of 14.5% for PIN, 13% for ADT Indication | 9M Euros for ADT | 25M Euros for PIN
59
TagOut/InEither partyPhase II data50% of dev costs (FTE & direct out-of-pocket)8/2006Human Genome SciencesGlaxoSmithKlineTop PharmaLead MoleculeFOIA 24.00 24.00 50.00 DealWorldwideBenlysta (belimumab hMAb to BLyS) to treat lupus
Co-Development, Co-Promotion, License, Supply
Autoimmune/InflammatorySystemic Lupus ErythematosusMonoclonalsHuman Abs 24.00 50.00
60
TagOut/InEither partyAny30% of share of dev costs1/2006ARCA BiopharmaBayerTop PharmaPhase IIIFOIA 50.00 385.00 37.50 Deal
Africa, Asia, Europe, Middle East, NAFTA, South America
Alfimeprase for peripheral arterial occlusions ex-USCo-Development, License, TerminationCardiovascularPeripheral Arterial DiseaseRecombinant DNA 0.30 75.00 90.00 215.00 170.00 17.50 23.00 27.75 15.00
61
TagOut/InEither partyAny2x share of development costs12/2005Agennix, GPC BiotechCelgene, PharmionMajor BiotechPhase IIIFOIA 37.10 247.60 34.00 DealAsia, Europe, Middle East
Satraplatin for prostate cancer in Europe, Mideast, Australia & New Zealand
Co-Development, License, SupplyCancerProstateNatural Product 0.26 30.50 75.00 142.60 105.00 27.00 29.00 31.44 10.00
62
TagOut/InEither partyPhase IIb data200% of share of dev cost9/2005Facet, Abbott, AbbVie, PDL BioPharmaBiogenMajor BiotechPhase II, Orphan IndicationFOIA 40.00 520.00 50.00 DealWorldwide
Zinbryta (daclizumab) for multiple sclerosis, M200 (volociximab) & HuZAF (fontolizumab)
Co-Development, Co-Promotion, Equity, License, Supply
Autoimmune/Inflammatory, Cancer, Central Nervous System
Broad Focus Autoimmune/Inflammatory, Multiple Sclerosis, Solid Tumors
MonoclonalsHumanized Abs 5.00 0.25 85.00 240.00 370.00 50.00 12.00 13.60 16.80 15.00 50.00
$85M in dev/reg milestones for IL-2R or INFy for 1st indication | $80M for each of 2nd & 3rd IL-2R or INFy indications, plus $40M for each of 2nd &3rd A5B1 indications | 50/50 PS in NA and EU | ROW Royalty of 12-20%
63
TagOut/InEither partyAny75% dev cost b4 first Ph III data; 100% if later5/2005BioMarinMerck Serono, SeronoTop Pharma
Phase III, Preclinical, Orphan Indication
FOIA 25.00 257.00 18.00 Deal
Africa, Asia, Europe, Middle East, NAFTA, South America
Kuvan (sapropterin dihydrochloride) and Phenylase (phenylalanine ammonia lyase) ex-NA & Japan
Co-Development, License, Supply, Termination
Endocrinological & MetabolicOther Endocrinological & MetabolicRecombinant DNA, SyntheticsSmall Molecule 45.00 187.00 257.00 11.50 14.20 16.10
64
TagOut/InEither party1 yr from Opt-out2-3.5x share of dev cost, depending on stage3/2005ARCA BiopharmaKirinJapanese PharmaPreclinical, DiscoveryFOIA 2.00 2.00 60.00 DealWorldwideNU206 growth factor for radiation-induced mucositis and IBDCo-Development, License, SupplyDental/Oral, GastrointestinalIBD - Other, MucositisRecombinant DNA 0.25 2.00 10.00 60.00
2-9.975% royalty after opt-out, depending on stage and which party opts out
65
TagOut/InEither partyPhase IIb data75% of dev costs or 100% if approved1/2005New River PharmaceuticalsTakeda, Shire
Major Biotech, Top Pharma
Phase IIIFOIA 50.00 505.00 50.00 DealWorldwideVyvanse (NRP104 lisdexamfetamine dimesylate) for ADHD
Co-Development, Co-Promotion, License, Supply
PsychiatricAttention Deficit Hyperactivity Disorder 355.00 405.00 100.00 12.00 13.20 14.60 20.00 50.00
12-16% in Major EU; 12% in ROW except for Major EU and US | COGS +20% | US profit split of 25% to New River for first two years, then 50% thereafter
66
TagOut/InEither partyPhase II data250% of dev costs9/2004XomaAphtonOther BiotechDiscoveryFOIA 30.00 DealWorldwideAnti-gastrin monoclonal antibodies
Co-Development, Co-Promotion, License, Option, Supply
CancerColorectal, Other CancerMonoclonalsHuman Abs 0.33 30.00
67
TagOut/InEither partyPhase III data62.5% dev cost (Ph II) or 75% (Ph III)4/2004GenentechRocheTop PharmaDiscoverySEC Full 50.00 DealWorldwideJoint research in oncology, immunology and protein therapeutics
Co-Development, Co-Promotion, License, Option, Research, Supply
Autoimmune/Inflammatory, Cancer
Broad Focus Autoimmune/Inflammatory, Broad Focus Cancer
Recombinant DNA, SyntheticsSmall Molecule 20.00 50.00
68
TagOut/InEither partyPhase III data150% dev cost (plus 5% royalty if Ph III)9/2002Bristol-Myers Squibb, AmylinLillyTop PharmaPhase IIIFOIA 80.00 555.00 50.00 DealWorldwideBYETTA (exenatide) GLP-1 for type 2 diabetes
Co-Development, Co-Promotion, Equity, License, Loan, Option, Supply, Termination
Endocrinological & MetabolicDiabetesSyntheticsSmall Molecule 30.00 110.00 0.27 110.00 155.00 70.00 555.00 50.00
$70M on SR Product launch | $60M development and $50M commercialization credit facilities | 50/50 in US; 80/20 in favor of Lilly ex-US up to $1B/yr, then 75/25 in favor of LIlly ex-US
69
TagOut/InEither partyPhase I data200% of internal and out-of-pocket costs4/2002GentaSanofi, AventisTop PharmaPhase IIIFOIA 50.00 405.00 28.00 DealWorldwideGenasense (G3139 BCL-2 downregulator) for cancer
Co-Development, Co-Promotion, Equity, License, Loan, Supply
CancerBroad Focus CancerOligonucleotidesAntisense/Triple helix 0.22 75.00 195.00 85.00 405.00 20.00 20.40 21.80
US: 15% on first $300M in cum US sales, then 20-28% royalty on annual US sales; ROW is 15-19% royalty (see separate contract | $75M convertible note (w/ conversion at 425th patient in Ph III trial)
70
TagOut/InEither partyPhase IIb dataReimb 75% of out-of-pocket dev costs4/1998Johnson & Johnson, CentocorMerck, Schering-PloughTop PharmaPhase IIIFOIA 20.00 62.00 40.00 Deal
Africa, Asia, Europe, Middle East, NAFTA, South America
Remicade (chimeric Anti-TNF antibody) for RA and IBD ex-US, Japan, China and Indonesia
Co-Development, Co-Promotion, Distribution, Option
Autoimmune/Inflammatory, Gastrointestinal
IBD - Crohn's Disease, IBD - Other, IBD - Ulcerative Colitis, Rheumatoid Arthritis
MonoclonalsHumanized Abs 12.00 10.00 20.00 62.00 40.00 $10M for Crohn's | 32% to $150M, then 40% > $150M/yr
71
TagOut/InEither partyAny10% interest on share thru I; 20% if later1/1998Lundbeck A/S, SynapticGrunenthalMid Tier PharmaDiscoveryFOIA 4.00 DealEurope, South America
Targeting alpha-2 adrenergic receptors to treat pain in Europe and S America
Co-Development, License, ResearchCentral Nervous SystemPainRecombinant DNA 4.00 4.00 4.00
72
TagOut/InEither partyFiling100% of Ph II or 125% of Ph III dev costs2/1997Transcend TherapeuticsBoehringer IngelheimMid Tier PharmaPhase IIIFOIA 5.00 46.00 25.00 DealWorldwide
Procysteine (glutathione-repleting agent) for Acute Respiratory Distress Syndrome (ARDS)
Co-Development, Co-Promotion, License, Supply, Termination
RespiratoryAcute Respiratory Distress Syndrome 5.00 13.00 23.00 46.00 25.00 25.00 25.00 7.00
25% in US, 10% in Japan, 15% in ROW | 7% of Net Sales cap on Manu Cost (plus royalty)
73
TagOut/InEither partyFiling10% interest on share thru II; 30% if Ph III5/1995IDM Pharma, Takeda, EpimmuneSchwarz PharmaMid Tier PharmaPhase IIFOIA 2.00 18.50 50.00 DealEurope, NAFTA
Cylexin (CY 1503 selectin blocker) for lung injury and MI in NAFTA & Europe
Co-Development, Co-Promotion, Equity, License, Supply
CardiovascularMyocardial InfarctionCarbohydrates 2.00 14.50 18.50 9.00 10.60 11.30 35.00 50.00
8-12% royalty in Europe if Cytel doesn't supply | 30-35% transfer price in Europe | 50% PS from co-promotion in NAFTA
74
TagOut/InEither partyPhase IIb dataAdd'l 4% royalty to rejoin dev after opt-out5/1991Millennium, Takeda, COR TherapeuticsLillyTop PharmaLead Molecule, DiscoveryFOIA 8.95 50.00 DealWorldwidePlatelet aggregation inhibitors (PAI) for cardiovascular
Co-Development, Co-Promotion, License, Option, Research
CardiovascularBroad Focus CardiovascularPeptides, SyntheticsSmall Molecule 7.70 1.25 8.95 50.00 7% royalty if no co-promotion
75
TagOut/InLicenseeAny3x option fee plus 4x dev cost incurred3/2013bluebird bioCelgeneMajor BiotechDiscoveryFOIA 75.00 505.00 50.00 DealWorldwideChimeric antigen receptor (CAR) T cell gene therapy for cancer
Co-Development, Co-Promotion, Equity, License, Loan, Option, Research
CancerBroad Focus Cancer
Cell Therapy - Stem Cells/Factors, Oligonucleotides
Gene Therapy 20.00 0.33 100.00 165.00 145.00 505.00 6.00 7.50 8.75 5.00 50.00
$20M or 9.9% OS in Bluebird IPO | 50/50 co-dev and PS option in US, w reduction in milestones to $70M for 1st, plus $40M for 2nd | Bluebird pays thru Ph I, then all by Celgene | $75M convertible Debt Financing for US Co-Dev; plus $25M non-convertible debt | $165M for 1st Indication | $80M in R&D Collaboration extension payments plus $65M for Second Indication
76
TagOut/InLicenseeFiling120% of dev costs, plus approval milestone9/2012OnconovaBaxalta, Shire, Baxter
Major Biotech, Top Pharma
Phase IIIFOIA 50.00 887.50 21.00 DealEurope, Middle East
Estybon (rigosertib multi-kinase inhibitor) for MDS and pancreatic cancer in Europe & Turkey
Co-Development, Equity, License, Option, Termination
CancerLeukemia, PancreaticSyntheticsSmall Molecule 50.00 5.00 207.50 325.00 637.50 250.00 13.00 14.50 16.75
$50M in preferred equity 7/12, per Onconova's 2014 10-K | $5M at IPO, per Onconova's 2014 10-K | $207.5M for MDS IV | $150M for MDS Oral, plus $175M for Pancreatic
77
TagOut/InLicenseePhase IIb data50% costs, plus add'l 15% costs going-forward9/2008Gilead, CV TherapeuticsMenariniMid Tier PharmaApproved, FormulationFOIA 70.00 285.00 33.00 DealEurope, South AmericaRenexa (ranolazine SR) for angina in Europe and S. America
Co-Development, Co-Promotion, License, Supply
CardiovascularAnginaDrug Delivery, SyntheticsSmall Molecule, Sustained Release 0.35 10.00 80.00 160.00 125.00 22.00 25.50 29.25 10.00 88.4M Euros
78
TagOut/InLicenseeFiling$20M, 115% costs, $55M milestones & +4% royalty6/2008rEVO BiologicsLundbeck A/S, Ovation PharmaMid Tier PharmaFiledFOIA 3.00 231.50 16.00 DealNAFTARecombinant antithrombin alfa for thromboembolic events in USCo-Development, License, SupplyCardiovascularOther CardiovascularRecombinant DNA, Transgenics 10.00 6.00 57.50 76.50 155.00 13.63 15.05 15.53
$10M for HR Indication dev | $6M for HD Indication | $17.5M for HR Indication, plus $40M for DIC/Sepsis Indication
79
TagOut/InLicenseePhase II data150% cost if IND tox; 300% cost if first Ph II10/2006InterMuneRocheTop PharmaPreclinicalFOIA 60.00 560.00 19.00 DealWorldwideDanoprevir (ITMN-191) cyclic macrocycle for HCV
Co-Development, Co-Promotion, License, Termination
Infectious-ViralHepatitis CPeptides 250.00 310.00 240.00 14.00 15.00 17.00 50.00
80
TagOut/InLicenseePhase II datareturn to base milestone/royalty terms3/2006Merck, Alnylam, Sirna TherapeuticsGlaxoSmithKlineTop PharmaDiscoveryFOIA 6.00 99.50 8.00 DealWorldwidesiRNA therapeutics for PDE4A, PDE4B & RSV respiratory targetsEquity, License, ResearchInfectious-Viral, Respiratory
Broad Focus Respiratory, Respiratory Syncytial Virus/RSV
OligonucleotidesRNAi 6.00 47.50 40.00 99.50 6.00 6.00 7.00
$6M eq at 25% premium | $3-5M Target Expansion Fee, plus $17.5M for each of 2nd and 3rd indications
81
TagOut/InLicenseePhase III data2x cost if Ph II; 3x thru II & 2x add'l if III 12/2004Amgen, MicrometMerck Serono, SeronoTop PharmaPhase IIFOIA 10.00 148.00 15.00 DealWorldwide
MT201 (adecatumumab) anti EpCAM human monoclonal for cancer
Co-Development, Co-Promotion, License, Option
CancerBreast, ProstateMonoclonalsHuman Abs 0.20 84.00 54.00 148.00 8.00 8.50 9.25 50.00
royalty is in addition to any profit split for co-co dev | 50% PS if co-dev & co-promote in US and/or EU
82
TagOut/InLicenseeAny45% (3 yr) or 80% dev cost reimb6/2003Takeda, MillenniumJohnson & Johnson, Ortho BiotechTop PharmaFiledFOIA 15.00 505.00 24.00 Deal
Africa, Asia, Europe, Middle East, NAFTA, South America
VELCADE (bortezomib) for myeloma ex-US
Co-Development, Co-Promotion, License, Option, Supply
CancerBroad Focus Cancer, Multiple MyelomaSyntheticsSmall Molecule 0.28 75.00 300.00 390.00 115.00 13.00 14.80 18.20 15.00
83
TagOut/InLicenseePhase IIb data150% of option exercise amt ($35-75M)10/2002ExelixisGlaxoSmithKlineTop PharmaDiscoveryFOIA 30.00 614.00 17.00 DealWorldwide
Chk1, SS-RTK, ADAM10 & Dual KDR/FGFR1 inhibitor targets for cancer, cardio & inflammation
Co-Development, Co-Promotion, Equity, License, Loan, Option, Research, Termination
Autoimmune/Inflammatory, Cancer, Cardiovascular
Broad Focus Autoimmune/Inflammatory, Broad Focus Cancer, Broad Focus Cardiovascular
Genomics, SyntheticsGene Expression, Small Molecule 14.00 30.00 90.00 85.00 165.00 150.00 564.00 50.00 10.00 10.00 10.75
$14M (2M @ $7/sh) in initial equity @ 100% premium per 10/28/02 PR | $30M add'l put equity @ 125% of FMV if GSK Expands Program | $90M over 6 yrs | 10-13% for 1st product (increasing for add'l products, up to 13-17% for 5 products) | $85M loan facility (increasing to $300M if GSK Expands Program) | $35-75M for 1st Compound, depending when accepted by GSK | $20M on Expanded Option exercise, $40M in Expanded Option payments plus add'l $90M in R&D funding
84
TagOut/InLicenseePhase IIb data125% share of dev cost (direct & indirect)8/1998VertexBayer, Schering AGTop PharmaPreclinical, Lead MoleculeFOIA 6.00 87.50 30.00 DealWorldwide
VX-853 & orally active neurophilin compounds for neurological diseases
Co-Development, Co-Promotion, License, Research, Supply
Central Nervous SystemBroad Focus Central Nervous SystemSyntheticsSmall Molecule 22.00 25.00 34.50 87.50 15.00 15.00 15.00 30.00
$25M for VX-853 | 25-30% transfer price, depending on annual sales | $17.25M in milestones for other compounds, 2x max
85
TagOut/InLicenseePhase IIb data150% share to IND; 200% if pre-II or 250%10/1995Purdue Pharma, CoCensysPfizer, Warner-LambertTop PharmaLead Molecule, DiscoveryFOIA 25.70 9.00 DealWorldwideNMDA receptor subtype antagonists for CNS diseases
Co-Promotion, Development, Equity, License, Option, Research
Central Nervous SystemBroad Focus Central Nervous SystemScreening, SyntheticsSmall Molecule 7.00 2.20 0.22 11.50 5.00 25.70 6.00 6.00 6.75 25.00
9% of Net Sales if Co-Promote in US | 15-25% PS if CoCensys elects to codev
86
TagOut/InLicenseeIND2x dev costs incurred (FTE & external)5/1995Amgen, Onyx PharmaceuticalsPfizer, Warner-LambertTop PharmaLead MoleculeFOIA 30.20 8.00 Deal
Africa, Asia, Europe, Middle East, NAFTA, South America
Ibrance (Palbociclib PD-0332991 CDK4 inhibitor) for breast cancer ex-Japan
Co-Promotion, Equity, License, Research, Restatement
CancerBreastScreening, Transcription Factors 7.00 6.20 8.50 8.50 30.20 8.00 8.00 8.00
87
TagInEither partyPhase II data45-200% dev cost, depending on party & stage6/2015Juno TherapeuticsCelgeneMajor BiotechPhase IIFOIA 150.20 1,150.20 50.00 DealWorldwideCAR-T and TCR technologies for cancer and autoimmune diseases
Co-Development, Co-Promotion, Equity, License, Option
Autoimmune/Inflammatory, Cancer
Broad Focus Autoimmune/Inflammatory, Broad Focus Cancer
Cell Therapy - Stem Cells/Factors 850.00 150.00 1,100.00 50.00
9.1M shares @ $93/sh | Celgene has contingent rights to purchase up to 30% OS of Juno, per Celgene corp presentation | 50% PS on Juno originated programs (other than CD19 or CD22) & 30% PS globally on Celgene-originated programs | $50-75M on option exercise for each of CD19 & CD22 Program, depending on stage at exercise
88
TagInLicenseePhase I data$20M plus add'l 1% royalty3/2015Ziopharm, IntrexonMerck KGaA, Merck Serono, PrecigenTop PharmaDiscoveryFOIA 115.00 608.00 13.00 DealWorldwideChimeric antigen receptor T-cell (CAR-T) products for cancer
Assignment, License, Option, Research, Supply
CancerBroad Focus CancerCell Therapy - Stem Cells/Factors 10.00 77.50 200.50 403.00 205.00 2.00 3.00 4.50
$205M per Product | $10M for first two Targets, plus $5M for each add'l Target selected by Serono | $77.5M for 1st indication | $130.5M for add'l indications, plus $20M if Serono opts-in for Out-of-Scope Target; $40M for Allogeneic Cell Therapy entering Ph II or III using cells not from patients in trial; $10M on initiation of Ph III for solid tumor indication
89
TagInLicenseePhase II data$3-25M plus 50% cost, depending on stage & PS1/2015AgenusIncyteMajor BiotechLead Molecule, DiscoveryFOIA 25.00 495.00 15.00 DealWorldwide
Retrocyte Display platform to develop immuno-oncology antibodies targeting GITR, OX40, LAG-3 & TIM-3
Co-Development, Co-Promotion, Equity, License, Option, Research
CancerBroad Focus CancerMonoclonalsHuman Abs, Humanized Abs 35.00 60.00 0.28 220.00 85.00 425.00 70.00 15.00 15.00 15.00
Add'l 10M shares purchased 2/17 @ $6/sh, per Agenus' 9Q17 | 6-12% for Royalty-Bearing Products (TIM-3 & LAG-3); 15% royalty on GITR & OX-40 per 2/17 Amendment per Agenus' 9Q17 | 50/50 sharing of profits for the GITR and OX40 antibody programs, plus two of the add'l targets added in 11/15, per Agenus' 2016 10-K; PS eliminated per 2/17 Amendment per Agenus' 2016 10-K | $70M for Royalty-Bearing Products | Initially $20M for Profit-Share Products (GITR & OX-40); As of 2/17 Am, add'l milestones for GITR and OX-40 of $220M in aggregate, per Agenus' 9Q17 | $80M for each Royalty-Bearing Product | $490M (counting 2/17 add'l equity, and 1 Royalty-Bearing Product)
90
TagInLicenseePreclin tox$7.5M plus 50% of dev costs (FTE & other)7/2006AlnylamMerckTop PharmaDiscoveryFOIA 84.50 50.00 DealWorldwideRNAi for nine non-druggable targets
Co-Development, Co-Promotion, License, Option, Research, Restatement, Termination
UnlimitedOligonucleotidesRNAi 0.49 41.00 43.50 84.50 10.00 11.40 13.00 50.00
10-15% ROW royalty for RNAi Products; 5-10% on Merck Development Products | $30.5M for Opt-out RNAi Product; $5.5M for Profit Sharing RNAi Product; $7.5M on Merck's Opt-in for RHOA Product | 50/50 PS on Profit Sharing RNAi Products in US | $41M for Merck Development Products
91
TagInLicenseePhase II data$10M IND ($42M POC) exercise +$47M milestones12/2005Catalyst Biosciences, TargaceptAstraZenecaTop PharmaPhase II, DiscoveryFOIA 10.00 373.40 19.00 DealWorldwide
Neuronal nicotinic receptors, including TC-1734 for Alzheimer's and cognitive dysfunction
Co-Promotion, Development, License, Option, Research, Termination
Central Nervous System, PsychiatricAlzheimer's Disease, SchizophreniaSyntheticsSmall Molecule 26.40 0.27 165.00 172.00 373.40 11.00 11.00 12.00
$26.4M over 4 yrs | IND: $10M on Option Compound exercise, plus $75M dev/reg; POC: $42M on exercies, plus $130M dev/reg
92
TagInLicenseePhase III doneterms TBD9/2004Merck KGaAClinical Data, Genaissance PharmaceuticalsOther BiotechPhase IIFOIA 45.50 10.00 DealWorldwide
Vilazodone (selective serotonin reuptake inhibitor (SSRI) & 5HT1A partial agonist) for depression
Co-Development, Co-Promotion, Equity, License, Option
PsychiatricDepression & ManiaSyntheticsSmall Molecule 1.30 44.20 45.50 10.00 10.00 10.00
1M Euros of Genaissance equity | 34M Euros worth of equity for milestones
93
TagInLicenseePreclin tox$7.5M plus 50% of dev costs (FTE & other)9/2003AlnylamMerckTop PharmaDiscoveryFOIA 4.00 16.00 50.00 DealWorldwideRNAi technology for non-druggable targets
Co-Development, Co-Promotion, Equity, License, Option, Research, Termination
UnlimitedOligonucleotidesRNAi 5.00 5.00 2.00 16.00 10.00 11.40 13.00 50.00
10-15% ROW royalty for RNAi Products; 5-8% on Merck Products | 50/50 PS on Profit Sharing RNAi Products in US
94
TagInLicenseeIND$1M plus 50% of fully burdened dev cost5/2001ExelixisPDL BioPharmaOther BiotechDiscoveryFOIA 44.50 40.00 DealWorldwideHumanized antibodies for cancer
Co-Development, License, Loan, Option, Research
CancerBroad Focus CancerMonoclonalsHumanized Abs 8.00 30.00 6.50 44.50 7.00 7.00 7.00 40.00
95
TagInLicenseeApproval50% of Ph II & 75% of Ph III dev cost7/1999GenentechRocheTop PharmaApproved, Orphan IndicationSEC Full 1,900.00 20.00 DealWorldwideDNase/Pulmozyme drug and affiliation agreementDevelopment, ResearchRespiratoryCystic FibrosisDrug DeliveryOther
96
TagInLicenseeINDReimb 300% dev costs (200% after Term)4/1994Amgen, Onyx PharmaceuticalsBayerTop PharmaDiscoveryFOIA 78.50 50.00 DealWorldwide
Nexavar (sorafenib) oral Ras kinase inhibitor for liver & kidney cancer
Co-Development, Co-Promotion, Equity, License, Loan, Research, Settlement
CancerKidney, LiverScreening, Transcription Factors 13.50 25.00 0.20 40.00 78.50 50.00
7% royalty for Japan & any co-dev opt-out countries | 50/50 PS in all co-dev countries (Onyx opted-out in Japan)
97
TagInLicensorPhase II data65% cost (max $10M) at IND; 90% (max $25M) at II7/2007Roche, GenentechIpsen, TercicaMid Tier PharmaPreclinicalFOIA 18.00 12.00 DealWorldwideGrowth hormone & IGF-1 combination product for short stature
Co-Development, Co-Promotion, Equity, License, Option
Endocrinological & MetabolicGrowth Hormone DisordersRecombinant DNA 4.00 9.00 5.00 18.00 12.00 12.00 12.00 25.00 50.00
GNE purchases 708.6K Tercica shares | Add'l $4M eq purchase if GNE extends opt-in period, plus $5M eq at approval | 12% royalty to GNE if GNE never opts-in | 50/50 PS for Short Stature and AGHD Indications after GNE opt-in, but drops to 33.3% if GNE pays $10M to have tie-breaking vote
98
TagInLicensorPhase IIb dataIL-1: $140M for 45% PS in NAFTA3/2003Regeneron PharmaceuticalsNovartisTop PharmaPhase IIFOIA 27.00 625.00 50.00 Deal
Africa, Asia, Europe, Middle East, NAFTA, South America
IL-1 Trap for rheumatoid arthritis ex-Japan
Co-Development, Co-Market, Co-Promotion, Equity, License, Option
Autoimmune/InflammatoryRheumatoid ArthritisRecombinant DNA 48.00 0.30 50.00 125.00 500.00 50.00 50/50 PS for
99
TagInLicensorPhase IIb data35% US PS or 2% higher royalty4/2002Cubist, Merck, AdolorGlaxoSmithKlineTop PharmaPhase IIIFOIA 50.00 260.00 50.00 DealWorldwide
Entereg (alvimopan mu receptor antag) for postop ileus, IBS and constipation
Co-Development, Co-Promotion, License, Supply, Termination
Gastrointestinal
Bowel Movement Disorders, IBD - Other, Other Gastrointestinal
SyntheticsSmall Molecule 50.00 160.00 260.00 20.00 20.00 20.00 50.00
18-20% royalty for Ex-US, depending on Product indication | $40M for IBS Product; $30M for each of Constipation & OBD Acute Products; $25M for OBD Chronic Product; $35M max for Add'l Products | 35-50% US PS, depending on years from launch and Product indication
100
TagInLicensorAnyFee TBD but 30% of cost attributed to US3/1995Biogen, IDECRoche, GenentechTop PharmaPhase IIFOIA 4.00 56.50 40.00 DealWorldwide
Rituxin (rituximab chimeric CD20 MAb) for non-Hodgkin's lymphoma and RA
Co-Development, Co-Promotion, Equity, License, Supply
Autoimmune/Inflammatory, CancerLeukemia, Lymphoma, Rheumatoid ArthritisMonoclonals 5.00 17.50 30.00 56.50 11.25 11.70 11.85 40.00
$5M pref eq at 3/95 signing | 10-12% royalty ex-NA | 30% PS in NA up to $50M in Operating Profits, then 40% PS in NA above $50M/yr
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